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1 | Rank | NCT Number | Expert search terms | Title | Recruitment | Study Results | Conditions | Interventions | Sponsor/Collaborators | Gender | Age Groups | Phases | Enrollment | Funded Bys | Study Types | Study Designs | Other IDs | First Received | Start Date | Completion Date | Last Updated | Last Verified | Results First Received | Acronym | Primary Completion Date | Outcome Measures | URL |
3 | 2 | NCT00352898 | NCT00352898 | Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™ | Completed | No Results Available | Rubella|Varicella|Mumps|Measles | Biological: MeMuRu-OKA (study vac)|Biological: MMR, Varicella vacc (control) | GlaxoSmithKline | Both | Child | Phase 2 | 400 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 105909 | July 14, 2006 | April 2006 | September 29, 2011 | September 2011 | No Study Results Posted | Varicella, MMR titres at 42-56 days after first vaccination|Seropositivity rates. Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study) | http://ClinicalTrials.gov/show/NCT00352898 | |||
4 | 3 | NCT00353288 | OR NCT00353288 | Immunogenicity, Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™ | Completed | No Results Available | Measles|Mumps|Rubella|Varicella | Biological: MeMuRu-OKA (study vacc)|Biological: MMR, Varicella vacc (control) | GlaxoSmithKline | Both | Child | Phase 2 | 446 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 105908 | July 17, 2006 | March 2006 | October 9, 2008 | October 2008 | No Study Results Posted | November 2006 | Varicella seroconversion and MMR titres at 42-56 days after first vaccination|Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study) | http://ClinicalTrials.gov/show/NCT00353288 | ||
7 | 6 | NCT00197015 | OR NCT00197015 | Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children | Completed | Has Results | Hepatitis A Vaccine|Hepatitis A | Biological: Havrix®|Biological: M-M-R®II|Biological: VARIVAX® | GlaxoSmithKline | Both | Child | Phase 3 | 1474 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 208109/231 | September 13, 2005 | October 2003 | June 2009 | April 11, 2013 | November 2012 | March 11, 2010 | January 2009 | Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups.|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups|Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups|Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups|Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Antibody Titers in HAV+MMR+V and MMR+V→HAV Groups|Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups|Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V→HAV Group|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value in MMR+V→HAV Group|Number of Subjects With Vaccine Response to Havrix®|Number of Subjects Reporting Solicited Local Symptoms|Number of Subjects Reporting Solicited General Symptoms|Number of Subjects Reporting Measles, Mumps, Rubella and Varicella Specific Solicited General Adverse Events|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Number of Subjects Reporting Serious Adverse Events (SAEs)|Number of Subjects Reporting New Chronic Illnesses|Number of Subjects Reporting Medically Significant Events | http://ClinicalTrials.gov/show/NCT00197015 | |
8 | 7 | NCT01874457 | OR NCT01874457 | Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella) | Completed | No Results Available | Mumps|Rubella|Measles | Biological: MMR (Mumps, Measles and Rubella) | The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) | Both | Child | 150 | Other | Observational | Time Perspective: Prospective | ASCLIN/002/2008 | June 7, 2013 | May 2008 | August 2009 | June 13, 2013 | June 2013 | No Study Results Posted | March 2009 | Immunoresponse after first dose|Immunoresponse after revaccination | http://ClinicalTrials.gov/show/NCT01874457 | ||
9 | 8 | NCT00474266 | OR NCT00474266 | Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children | Completed | No Results Available | Rubella|Meningococcal Serogroup A, C, W-135, Y Diseases|Varicella|Mumps|Measles | Biological: Meningococcal vaccine GSK134612|Biological: Priorix-Tetra™|Biological: Meningitec™ | GlaxoSmithKline | Both | Child | Phase 3 | 1000 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 109670 | May 15, 2007 | June 2007 | February 2008 | June 7, 2012 | February 2011 | No Study Results Posted | February 2008 | Meningococcal rSBA titres|Anti-measles seroconversion|Anti-mumps seroconversion|Anti-rubella seroconversion|Anti-varicella seroconversion|Meningococcal rSBA titres|Anti-meningococcal polysaccharide concentrations|Anti-measles concentrations|Anti-mumps concentrations|Anti-rubella concentrations|Anti-varicella titres|Occurrence of solicited local and general symptoms|Occurrence of general symptoms specific for MMR and varicella vaccination (Priorix-Tetra™)|Occurrence of unsolicited symptoms|Occurrence of serious adverse events|Occurrence of specific adverse events of rash, new onset of chronic illness(es) and conditions prompting emergency room visits and physician office visits not related to common illnesses | http://ClinicalTrials.gov/show/NCT00474266 | |
11 | 10 | NCT00975507 | OR NCT00975507 | ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED) | Completed | Has Results | Measles|Mumps|Rubella|Varicella | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live|Biological: Comparator: Placebo|Biological: Comparator: Varivax|Biological: Comparator: M-M-R II | Merck Sharp & Dohme Corp. | Both | Child | Phase 3 | 480 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double Blind (Subject, Investigator) | V221-009|2009_660 | September 10, 2009 | March 1998 | June 1999 | April 29, 2014 | April 2014 | September 23, 2009 | January 1999 | Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline|Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL|Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | http://ClinicalTrials.gov/show/NCT00975507 | |
12 | 11 | NCT00388440 | OR NCT00388440 | Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore. | Completed | No Results Available | Measles|Mumps|Rubella | Biological: MMR vaccine (Priorix) | GlaxoSmithKline | Both | Child | Phase 4 | 150 | Industry | Interventional | Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Prevention|Masking: Open Label | 209762/147 | October 13, 2006 | November 2000 | October 13, 2006 | October 2006 | No Study Results Posted | Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)|Antibody concentration to all vaccine antigens after vaccination | http://ClinicalTrials.gov/show/NCT00388440 | |||
14 | 13 | NCT00985166 | OR NCT00985166 | A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014) | Completed | Has Results | Measles|Mumps|Rubella|Varicella | Biological: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)|Biological: Comparator: M-M-R II|Biological: Comparator: Varivax|Biological: Comparator: Placebo | Merck Sharp & Dohme Corp. | Both | Child | Phase 3 | 801 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double Blind (Subject, Investigator) | V221-014|2009_668 | September 24, 2009 | August 2000 | May 2003 | August 1, 2014 | August 2014 | December 23, 2009 | May 2002 | Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | http://ClinicalTrials.gov/show/NCT00985166 | |
15 | 14 | NCT00822237 | OR NCT00822237 | Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed) | Completed | Has Results | Varicella | Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)|Biological: Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)|Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR) | Merck Sharp & Dohme Corp. | Both | Child | Phase 3 | 598 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double Blind (Subject, Investigator, Outcomes Assessor) | V210-057|2009_510 | January 9, 2009 | January 2009 | December 2009 | April 29, 2014 | April 2014 | October 28, 2010 | October 2009 | Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process). | http://ClinicalTrials.gov/show/NCT00822237 | |
16 | 15 | NCT00313950 | OR NCT00313950 | Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine | Completed | No Results Available | Measles|Mumps|Rubella|Hepatitis A | Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella|Biological: Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine|Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella | Sanofi Pasteur, a Sanofi Company|Sanofi | Both | Child | Phase 4 | 470 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Single Blind (Outcomes Assessor) | HAF65 | April 11, 2006 | September 2006 | April 2010 | January 17, 2014 | January 2014 | No Study Results Posted | December 2009 | To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines. | http://ClinicalTrials.gov/show/NCT00313950 | |
17 | 16 | NCT00263653 | OR NCT00263653 | Safety, Reactogenicity & Immunogenicity Study to Evaluate a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™ in Toddlers (13-14 m) Primed With 3 Doses of Hib and MenC-CRM197 | Completed | No Results Available | Haemophilus Influenzae Type b|Neisseria Meningitidis | Biological: Haemophilus influenzae type b- and meningococcal (vaccine) | GlaxoSmithKline | Both | Child | Phase 3 | 297 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 103954 | December 8, 2005 | March 2005 | September 2005 | June 26, 2014 | June 2014 | No Study Results Posted | March 2005 | Any grade 3 solicited symptoms (d 0 - 3)|Sol (d 0-3, local & general), unsol & MMR specific (d 0-42) symptoms. SAEs (whole study). Subjects with Hib-MenC (pre&42 d post vacc): SBA-MenC titers, anti-PRP, -PSC conc. Subjects with MMR (42 d post vacc): anti-measles, -mumps, -rubella seroconversion | http://ClinicalTrials.gov/show/NCT00263653 | |
18 | 17 | NCT00488683 | OR NCT00488683 | B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants | Completed | Has Results | Meningococcal Disease | Biological: MenACWY-CRM|Biological: DTaP-Hib-IPV|Biological: PCV|Biological: MMR|Biological: Hib | Novartis Vaccines|Novartis | Both | Child | Phase 2 | 216 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | V59P16|2006-003476-35 | June 19, 2007 | July 2007 | June 2009 | September 5, 2014 | September 2014 | May 30, 2013 | May 2009 | Summary of Memory B Cells Per 2 x 105 LOC by Serogroup A, C, W-135 and Y|Memory B Cells by Serogroup A, C, W-135 and Y|Memory B Cells Per 2x100000 by Serogroup A,C, W-135 and Y at One Month After Primary MenACWY-CRM Vaccination and Third MenACWY-CRM Vaccination|Memory B Cells 1 Month After Primary Vaccination and Rise From Pre-third Dose to 1 Month After Third Dose of MenACWY-CRM Vaccination|Memory B Cells 1 Month After Primary Vaccination and 1 Week After Third Vaccination by Serogroup A, C, W-135 and Y|CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and at 12 Months of Age and One Month After MenACWY-CRM Third Vaccination|Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|Increase in Serogroup A, C, W-135 and Y Specific hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination|Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination|Serogroup A, C, W-135 and Y Specific hSBA Titers After MenACWY-CRM Primary Vaccination|Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants|Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM|Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months|Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations.|Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations|Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age|Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age|Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination | http://ClinicalTrials.gov/show/NCT00488683 | |
19 | 18 | NCT00156559 | OR NCT00156559 | MMR and Varicella Vaccine in Premature Infants | Completed | No Results Available | Chickenpox|Rubella|Rubeola|Mumps | University of Rochester | Both | Child | Phase 4 | 32 | Other | Observational | Time Perspective: Prospective | DMID 03-140|N01-AI-25460 | September 8, 2005 | January 2004 | May 2005 | June 12, 2008 | September 2005 | No Study Results Posted | http://ClinicalTrials.gov/show/NCT00156559 | ||||
22 | 21 | NCT00871117 | OR NCT00871117 | Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years | Completed | Has Results | Diphtheria|Pertussis and/or Poliomyelitis Diseases|Tetanus | Biological: GSK Biologicals'Kinrix®|Biological: Merck and Company's MMRII|Biological: Merck and Company's Varivax | GlaxoSmithKline | Both | Child | Phase 3 | 478 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 111852 | March 26, 2009 | March 2009 | January 2010 | February 17, 2011 | February 2011 | January 13, 2011 | January 2010 | Number of Subjects With Booster Responses to Diphteria and Tetanus|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL)|Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Above Cut-off Value|Geometric Mean Concentrations (GMCs) for Anti-D and Anti-T Antibodies|GMCs for Anti-PT, Anti-FHA, Anti-PRN Antibodies|Number of Subjects With an Anti-polio 1, 2, 3 Booster Response|Number of Subjects Seroprotected Against Diphteria and Tetanus|Number of Subjects Protected Against Poliovirus 1, 2 and 3|Number of Subjects Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Number of Subjects With Solicited Local and General Symptoms|Number of Subjects With Unsolicited Adverse Events|Number of Subjects With Serious Adverse Events (SAEs) | http://ClinicalTrials.gov/show/NCT00871117 | |
23 | 22 | NCT00986232 | OR NCT00986232 | ProQuad Dose Selection Study (V221-011)(COMPLETED) | Completed | Has Results | Measles|Mumps|Rubella|Varicella | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live|Biological: Comparator: M-M-R II|Biological: Comparator: PUVV | Merck Sharp & Dohme Corp. | Both | Child | Phase 2 | 1551 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double Blind (Subject, Investigator) | V221-011|2009_667 | September 25, 2009 | April 1999 | September 2000 | April 30, 2014 | April 2014 | January 25, 2010 | April 2000 | Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL|Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)|Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)|Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)|Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)|Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) | http://ClinicalTrials.gov/show/NCT00986232 | |
25 | 24 | NCT00406211 | OR NCT00406211 | Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine | Completed | No Results Available | Rubella|Varicella|Mumps|Measles | Biological: MMRV|Biological: MMR (Priorix®)|Biological: Varicella (Varilrix®) | GlaxoSmithKline | Both | Child | Phase 3 | 398 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 208136/039|208136/040|208136/041 | December 1, 2006 | July 2004 | December 2004 | November 8, 2012 | November 2012 | No Study Results Posted | December 2004 | Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year|Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination | http://ClinicalTrials.gov/show/NCT00406211 | |
26 | 25 | NCT00000815 | OR NCT00000815 | A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group | Completed | No Results Available | HIV Infections|Measles | Biological: Attenuvax|Biological: M-M-R-II | National Institute of Allergy and Infectious Diseases (NIAID)|Merck Sharp & Dohme Corp. | Both | Child | Phase 2 | 270 | NIH|Industry | Interventional | Allocation: Randomized|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label | ACTG 225|11202 | November 2, 1999 | August 2001 | May 16, 2012 | May 2012 | No Study Results Posted | Comparison of measles seroconversion rates at 13 months of age between HIV-infected children vaccinated at 12 months of age and HIV-infected children vaccinated at 6 and 12 months of age|Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children.|Comparison of seroconversion rates at 13 months of age (following single vaccination) of HIV-uninfected children with HIV-infected children following vaccination at 12 months of age|Comparison of measles seroconversion rates in HIV-infected children vaccinated at 6 months of age with HIV-infected children vaccinated at 12 months of age|Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees|Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees | http://ClinicalTrials.gov/show/NCT00000815 | |||
31 | 30 | NCT01198574 | OR NCT01198574 | Sub-clinical Inflammation and Iron Supplementation | Completed | Has Results | Anemia | Dietary Supplement: Iron group|Dietary Supplement: Vitamin A group|Dietary Supplement: Iron and vitamin A group|Dietary Supplement: Placebo group | Indonesia University|Department of Medical Research, Lower Myanmar | Female | Child|Adult | Phase 3 | 402 | Other | Interventional | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Factorial Assignment|Primary Purpose: Prevention|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) | SCIVA | September 8, 2010 | July 2010 | December 2010 | May 15, 2012 | May 2012 | December 31, 2011 | SCI&Anaemia | December 2010 | Haemoglobin Level|Status of Tissue Iron Store|Status of Cellular Iron Deficiency | http://ClinicalTrials.gov/show/NCT01198574 |
33 | 32 | NCT00262002 | OR NCT00262002 | Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants | Completed | Has Results | Prevention of Meningococcal Disease | Biological: MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)|Biological: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)|Biological: MenACWY PS (MenACWY-CRM, polysaccharide vaccine)|Biological: HBV (Hepatitis B vaccine)|Biological: Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)|Biological: MMR (Measles, Mumps and Rubella vaccine)|Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)|Biological: Menjugate (Men C conjugated vaccine) | Novartis Vaccines|Novartis | Both | Child | Phase 2 | 601 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | V59P5|2004-000195-13 | December 2, 2005 | September 2004 | October 2006 | June 16, 2014 | June 2014 | September 2, 2013 | July 2005 | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine|Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine|Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines|Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine|Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines|Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine|Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.|Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine|Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine|Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines|ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | http://ClinicalTrials.gov/show/NCT00262002 | |
35 | 34 | NCT00289783 | OR NCT00289783 | Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine | Completed | Has Results | Meningococcal Infection|Haemophilus Influenzae Type b Infection | Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine|Biological: ActHIB|Biological: PedvaxHIB|Biological: Pediarix|Biological: Prevnar|Biological: M-M-R II|Biological: Varivax | GlaxoSmithKline | Both | Child | Phase 3 | 4441 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double Blind (Subject, Caregiver, Investigator) | 103813|105067 | February 9, 2006 | February 2006 | August 2008 | October 18, 2012 | October 2012 | June 15, 2012 | February 2008 | Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations|Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers|Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers|hSBA-MenC Antibody Titers|hSBA-MenY Antibody Titers|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)|Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8|Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter|Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)|Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)|Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)|Number of Subjects With Anti-varicella Titer Equal to or Above 1:5|Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)|Anti-D and Anti-T Antibody Concentrations|Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)|Anti-HBS Antibody Concentrations|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)|Anti-poliovirus Types 1, 2 and 3 Titers|Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values|Anti-PSC and Anti-PSY Antibody Concentrations|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PRP Antibody Concentrations|Anti-PRP Antibody Concentrations|Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values|Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values|hSBA-MenC and hSBA-MenY Antibody Titers|hSBA-MenC and hSBA-MenY Antibody Titers|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PSC and Anti-PSY Antibodies Concentrations|Anti-PSC and Anti-PSY Antibody Concentrations|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value|Anti-PRP Antibody Concentrations|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PSC and Anti-PSY Antibody Concentrations|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)|Anti-PRP Antibody Concentrations|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4|Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)|Anti-measles Antibody Concentrations|Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values|Anti-mumps Antibody Titers|Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)|Anti-rubella Antibody Concentrations|Number of Subjects With Anti-varicella Titer Equal to or Above 1:40|Anti-varicella Antibody Titers|Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40|Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit|Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit|Number of Subjects Reporting Solicited Local and General Symptoms|Number of Subjects Reporting Solicited Local and General Symptoms|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)|Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination|Number of Subjects Reporting Serious Adverse Events (SAEs)|Number of Subjects Reporting Serious Adverse Events (SAEs)|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)|Number of Subjects Reporting Rash|Number of Subjects Reporting Rash|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8. | http://ClinicalTrials.gov/show/NCT00289783 | |
36 | 35 | NCT00985153 | OR NCT00985153 | Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children | Completed | Has Results | Measles|Mumps|Rubella|Varicella | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live|Biological: Comparator: Varivax|Biological: Comparator: M-M-R II | Merck Sharp & Dohme Corp. | Both | Child | Phase 3 | 3927 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double Blind (Subject, Investigator) | 2009_669|V221-012 | September 25, 2009 | March 2000 | May 2001 | April 21, 2010 | April 2010 | January 13, 2010 | May 2001 | Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL|Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer|Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer|Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer|Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer|Number of Participants With Serious Vaccine-related CAEs | http://ClinicalTrials.gov/show/NCT00985153 | |
37 | 36 | NCT00474526 | OR NCT00474526 | A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants | Completed | Has Results | Meningitis, Meningococcal | Biological: Meningococcal ACWY Conjugate Vaccine|Biological: DTaP-IPV-HBV|Biological: Hib|Biological: Rotavirus|Biological: Pneumococcal 7-valent Conjugate Vaccine|Biological: HAV|Biological: MMR-V|Biological: DTaP | Novartis Vaccines|Novartis | Both | Child | Phase 3 | 4545 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | V59P14 | May 16, 2007 | March 2007 | November 2009 | February 24, 2014 | February 2014 | May 27, 2013 | September 2008 | Percentage of Subjects With hSBA Titer >=1:8 - US Subjects|Geometric Mean hSBA Titers - US Subjects|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series|Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series|Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series|Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series|Geometric Mean hSBA Titers Post-infant Series - US Subjects|Geometric Mean hSBA Titers Post-infant Series - LA Subjects|Percentage of Subjects With hSBA Titer >=1:8 - US Subjects|Percentage of Subjects With hSBA Titer >=1:4 - US Subjects|Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects|Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects|Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects|Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects|Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects|Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects|Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject|Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject|Persistence Antibodies Geometric Mean Titers - US Subject|Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject|Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject|Persistence Antibodies Geometric Mean Titers - LA Subjects|Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects|Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects|Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects|Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects|Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects|Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects|Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects|Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects|Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects | http://ClinicalTrials.gov/show/NCT00474526 | |
38 | 37 | NCT00310856 | OR NCT00310856 | Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months) | Completed | Has Results | Meningococcal Meningitis | Biological: MenACWY-CRM|Biological: MenC-CRM|Biological: DTaP-Hib-IPV|Biological: PC7|Biological: MMR|Biological: Varicella | Novartis Vaccines|Novartis | Both | Child | Phase 2 | 175 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | V59P9 | April 3, 2006 | June 2005 | November 2006 | August 29, 2013 | August 2013 | August 29, 2013 | November 2006 | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age|Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age|hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age|hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age|Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | http://ClinicalTrials.gov/show/NCT00310856 | |
39 | 38 | NCT00257127 | OR NCT00257127 | Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs | Completed | No Results Available | HIV Infections | Biological: Pneumococcal 7-valent conjugate vaccine|Biological: Pneumococcal polysaccharide vaccine|Biological: Hepatitis B vaccine|Biological: Measles, mumps, and rubella virus vaccine, live | National Institute of Allergy and Infectious Diseases (NIAID)|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Both | Child|Adult | 101 | NIH | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label | P1061s|10132|PACTG P1061s | November 18, 2005 | February 2006 | August 2006 | December 4, 2013 | December 2013 | No Study Results Posted | August 2006 | Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol|Seropositivity, as determined by antibody levels|Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory | http://ClinicalTrials.gov/show/NCT00257127 | ||
40 | 39 | NCT00013871 | OR NCT00013871 | Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs | Completed | No Results Available | HIV Infections|Hepatitis B|Measles|Pneumococcal Infections|Pertussis | Biological: Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed|Biological: Measles-Mumps-Rubella Vaccine (Live)|Biological: Pneumococcal Vaccine, Polyvalent (23-valent)|Biological: Pneumococcal Conjugate Vaccine, Heptavalent|Biological: Hepatitis B Vaccine (Recombinant) | National Institute of Allergy and Infectious Diseases (NIAID)|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Both | Child|Adult | 300 | NIH | Interventional | Primary Purpose: Prevention | P1024|PACTG 1024|10609|ACTG P1024 | March 31, 2001 | November 2004 | November 25, 2013 | November 2013 | No Study Results Posted | http://ClinicalTrials.gov/show/NCT00013871 | |||||
43 | 42 | NCT00578175 | OR NCT00578175 | Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age | Completed | Has Results | Measles-Mumps-Rubella-Varicella Vaccine|Diseases Caused by Measles, Mumps, Rubella and Varicella Viruses. | Biological: Priorix-Tetra™ (MMRV vaccine 208136)|Biological: ProQuad®|Biological: Havrix®|Biological: Prevnar® | GlaxoSmithKline | Both | Child | Phase 2 | 1851 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double Blind (Subject, Outcomes Assessor) | 110058 | December 20, 2007 | November 2007 | February 2009 | January 31, 2013 | November 2012 | March 5, 2010 | February 2009 | Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)|Concentration of Antibodies to Varicella Virus (VZV)|Number of Subjects With Seroresponse for Antibodies to Mumps Virus|Number of Subjects With Seroresponse for Antibodies to Measles Virus|Number of Subjects With Seroresponse for Antibodies to Rubella Virus|Concentration of Antibodies to Hepatitis A Virus (HAV)|Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F|Antibody Titers to Mumps Virus|Concentration of Antibodies to Measles Virus|Concentration of Antibodies to Rubella Virus|Number of Subjects With Vaccine Response to Havrix®|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Number of Subjects Reporting Solicited Local Symptoms|Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination|Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination|Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash|Number of Subjects Reporting Investigator-confirmed Varicella-like Rash|Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling|Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)|Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits|Number of Subjects Reporting Serious Adverse Events | http://ClinicalTrials.gov/show/NCT00578175 | |
46 | 45 | NCT00984295 | OR NCT00984295 | Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines | Completed | Has Results | Measles|Mumps|Rubella|Varicella | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live|Biological: Comparator: Tripedia|Biological: Comparator: Comvax|Biological: Comparator: Varivax|Biological: Comparator: M-M-R II | Merck Sharp & Dohme Corp. | Both | Child | Phase 3 | 1913 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | V221-013|2009_666 | September 23, 2009 | June 2000 | December 2001 | August 1, 2014 | August 2014 | February 3, 2010 | October 2001 | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL|Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL|Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL|Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer|Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer|Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL|Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)|Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT|Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT|Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT|Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT|Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT|Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT|Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT|Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT|Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT | http://ClinicalTrials.gov/show/NCT00984295 | |
49 | 48 | NCT00103844 | OR NCT00103844 | Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia | Completed | Has Results | Chronic Myeloid Leukemia|Philadelphia-Positive Myeloid Leukemia | Drug: Dasatinib|Drug: Imatinib | Bristol-Myers Squibb | Both | Adult|Senior | Phase 2 | 150 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Crossover Assignment|Primary Purpose: Treatment|Masking: Open Label | CA180-017 | February 15, 2005 | February 2005 | March 2008 | August 3, 2010 | June 2010 | December 2, 2009 | August 2006 | Number of Participants With Major Cytogenetic Response (MCyR) at Week 12|MCyR at Any Time Prior to Crossover|Duration of MCyR at 12 Months and 18 Months|Duration of MCyR at 24 Months|Time to MCyR Prior to Crossover|Complete Hematologic Response (CHR) at Any Time Prior to Crossover|Duration of Complete Hematologic Response (CHR)|Time to CHR Prior to Crossover|Major Molecular Response (MMR)|CHR After Crossover|Cytogenetic Response After Crossover|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover|Health-Related Quality of Life Prior to Crossover|Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib | http://ClinicalTrials.gov/show/NCT00103844 | |
50 | 49 | NCT00101660 | OR NCT00101660 | Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib | Completed | Has Results | Chronic Myeloid Leukemia|Philadelphia-Positive Myeloid Leukemia | Drug: Dasatinib | Bristol-Myers Squibb | Both | Adult|Senior | Phase 2 | 387 | Industry | Interventional | Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label | CA180-013 | January 12, 2005 | February 2005 | April 2008 | February 29, 2012 | February 2012 | December 22, 2009 | September 2006 | Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)|Number of Imatinib-intolerant Participants With MCyR|Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months|Median Time From First Dosing Date to Date of MCyR|Number of Participants With Complete Hematologic Response (CHR)|Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months|Median Time From First Dosing Until CHR|Number of Participants With Major Molecular Response (MMR)|Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores|Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE|Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE|Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib | http://ClinicalTrials.gov/show/NCT00101660 | |
51 | 50 | NCT00101816 | OR NCT00101816 | Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate | Completed | Has Results | Chronic Myeloid Leukemia|Blast Crisis | Drug: Dasatinib | Bristol-Myers Squibb | Both | Adult|Senior | Phase 2 | 124 | Industry | Interventional | Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label | CA180-006 | January 13, 2005 | December 2004 | March 2008 | August 3, 2010 | June 2010 | December 15, 2009 | August 2006 | Major and Overall Hematologic Response (MaHR and OHR)|Median Duration of Major Hematologic Response (MaHR)|Median Duration of Overall Hematologic Response (OHR)|Time to MaHR and OHR|Number of Participants With Complete, Partial, Minor, Minimal, or No Cytogenetic Response|Number of Participants With CHR or NEL, MiHR, or no Hematologic Response|Number of Participants Achieving Major Molecular Response (MMR)|MaHR and Major Cytogenetic Response (MCyR) Among Participants With Baseline BCR-ABL Point Mutations|Minimally Significant Changes From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), AEs Leading to Discontinuation, Drug-Related AEs|Pharmacokinetics (PK) of Dasatinib - Maximum Observed Plasma Concentration (Cmax)|Pharmacokinetics (PK) of Dasatinib - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h or 24 h(AUC[0-T])|Pharmacokinetics (PK) of Dasatinib - Time to Maximum Observed Plasma Concentration (Tmax)|Pharmacokinetics (PK) of Dasatinib - Plasma Half-life (T-HALF)|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h (AUC[0-T])|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)|Population PK of Dasatinib | http://ClinicalTrials.gov/show/NCT00101816 | |
52 | 51 | NCT00101647 | OR NCT00101647 | Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia | Completed | Has Results | Chronic Myelogenous Leukemia | Drug: Dasatinib | Bristol-Myers Squibb | Both | Adult|Senior | Phase 2 | 197 | Industry | Interventional | Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Single Group Assignment|Primary Purpose: Treatment|Masking: Open Label | CA180-005 | January 12, 2005 | December 2004 | March 2008 | April 13, 2011 | April 2011 | December 22, 2009 | August 2006 | Major and Overall Hematologic Response (MaHR and OHR)|Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response)|Percentage of Participants Who Achieved MaHR and Did Not Progress at 24 Months in the Imatinib-Resistant Group (Based on the Kaplan-Meier Estimate of the Duration of Response)|Percentage of Participants Who Achieved OHR and Did Not Progress at 12 Months and 24 Months|Median Time in Days From First Dosing Date to Date of MaHR|Time to OHR|Best Cytogenetic Response|Best Confirmed Hematologic Response|Number of Participants Who Achieved a Major Molecular Response (MMR) During Treatment Period|MaHR and MCyR Among Participants With Baseline BCR-ABL Point Mutations|Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Hematologic Toxicities, and Toxicities Leading to Discontinuation|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 Hours (AUC[0-T])|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)|Population PK of Dasatinib | http://ClinicalTrials.gov/show/NCT00101647 | |
53 | 52 | NCT00432523 | OR NCT00432523 | Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route | Completed | No Results Available | Measles|Mumps|Varicella | Biological: M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX® | Sanofi Pasteur MSD | Both | Child | Phase 3 | 752 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Masking: Open Label | X04-MMRr-301 | February 7, 2007 | January 2005 | July 2006 | April 3, 2009 | April 2009 | No Study Results Posted | July 2006 | http://ClinicalTrials.gov/show/NCT00432523 | ||
54 | 53 | NCT00373958 | OR NCT00373958 | Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine | Completed | Has Results | Vaccines, Pneumococcal | Biological: 13 valent pneumococcal conjugate vaccine|Biological: 7vPnc pneumococcal conjugate vaccine | Pfizer | Both | Child | Phase 3 | 666 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double-Blind | 6096A1-004 | September 7, 2006 | September 2006 | June 2008 | January 17, 2013 | January 2013 | March 26, 2010 | June 2008 | Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series|Percentage of Participants Reporting Pre-specified Systemic Events|Percentage of Participants Reporting Pre-specified Local Reactions|Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)|Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose|Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose | http://ClinicalTrials.gov/show/NCT00373958 | |
55 | 54 | NCT00345683 | OR NCT00345683 | Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age. | Completed | Has Results | Meningococcal Infection|Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine|Haemophilus Influenza b Infections | Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)|Biological: PedvaxHIB|Biological: Prevnar|Biological: M-M-R II|Biological: Varivax | GlaxoSmithKline | Both | Child | Phase 3 | 4021 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Single Blind (Caregiver) | 105988 | June 26, 2006 | July 2007 | November 2008 | November 21, 2012 | November 2012 | June 15, 2012 | November 2008 | Number of Subjects Reporting Serious Adverse Events (SAEs)|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|Number of Subjects Reporting Rash|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Number of Subjects With Serious Adverse Events (SAEs)|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|Number of Subjects With Rash|Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits | http://ClinicalTrials.gov/show/NCT00345683 | |
56 | 55 | NCT00148941 | OR NCT00148941 | Immune Response & Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccine. | Completed | No Results Available | Poliomyelitis|Diphtheria|Pertussis|Prophylaxis|Tetanus | Biological: Diphtheria, tetanus, pertussis, poliovirus type 1, 2 & 3 | GlaxoSmithKline | Both | Child | Phase 3 | 4087 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 213503/048 | September 7, 2005 | January 2005 | November 2006 | February 2, 2012 | February 2012 | No Study Results Posted | November 2006 | Lot-to-lot consistency: immunogenicity one month post-vaccination:|Anti-D antibody concentrations, anti-T antibody concentrations, anti-PT antibody concentrations, anti-FHA antibody concentrations, anti-PRN antibody concentrations, anti-poliovirus type 1, type 2 and type 3 antibody titers.|Non-inferiority: immunogenicity one month post-vaccination:|Anti-D booster response, anti-T booster response, anti-PT booster response, anti-FHA booster response, anti-PRN booster response, anti-poliovirus type 1, type 2 and type 3 antibody titers|Safety:|incidence of increased circumferential swelling at the DTaP-containing vaccine injection site within 4 days after vaccination.|Immunogenicity one month after vaccination:|Anti-D antibody concentration, anti-T antibody concentration, anti-PT antibody concentration, anti-FHA antibody concentration, anti-PRN antibody concentration, anti-poliovirus type 1, type 2 and type 3 booster response|Safety:|Safety and reactogenicity of the study vaccines in all groups during the entire study period | http://ClinicalTrials.gov/show/NCT00148941 | |
57 | 56 | NCT00871000 | OR NCT00871000 | Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children. | Completed | No Results Available | Poliomyelitis|Diphtheria|Pertussis|Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines|Tetanus | Biological: Boostrix Polio™ 711866|Biological: Priorix Tetra TM 208136|Biological: Tetravac TM | GlaxoSmithKline | Both | Child | Phase 3 | 303 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 111815 | March 26, 2009 | April 2009 | November 2009 | January 22, 2011 | January 2011 | No Study Results Posted | November 2009 | Immunogenicity of the study vaccine antigens.|Immunogenicity of the study vaccine antigens.|Booster responses to study vaccine antigens.|Occurrence of solicited local and general symptoms.|Occurrence of unsolicited symptoms|Occurrence of serious adverse events (SAEs) | http://ClinicalTrials.gov/show/NCT00871000 | |
59 | 58 | NCT00892775 | OR NCT00892775 | Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds | Completed | No Results Available | Rubella Disease|Mumps Disease|Varicella Disease|Measles Disease | Biological: Priorix-Tetra TM (combined measles-mumps-rubella-varicella vaccine)|Biological: GSK Biologicals' 208136, new formulation | GlaxoSmithKline | Both | Child | Phase 2 | 501 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) | 108760 | May 4, 2009 | June 2009 | December 2010 | June 1, 2011 | May 2011 | No Study Results Posted | December 2010 | Seroconversion rates for measles, mumps, rubella and varicella|Measles, mumps, rubella and varicella seroconversion rates|Measles, mumps, rubella and varicella antibody titres|Occurrence of any and any grade 3 (severe) solicited local symptoms (injection site redness, pain and swelling)|Occurrence of any and any grade 3 (severe) solicited general in terms of fever, rash, any sign of meningitis including febrile convulsion and parotitis|Occurrence of unsolicited symptoms|Occurrence of serious adverse events | http://ClinicalTrials.gov/show/NCT00892775 | |
63 | 62 | NCT01148394 | OR NCT01148394 | Enhanced Recovery After Colorectal Surgery | Completed | No Results Available | Fast Track|Enhanced Recovery | Other: Multimodal rehabilitation | University of Valencia | Both | Adult|Senior | 119 | Other | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label | FT-1 | June 21, 2010 | January 2009 | June 2010 | June 21, 2010 | June 2010 | No Study Results Posted | March 2010 | Postoperative stay|Postoperative complications | http://ClinicalTrials.gov/show/NCT01148394 | ||
65 | 64 | NCT00192166 | OR NCT00192166 | Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Liquid Formulation (CAIV-T), Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months | Completed | No Results Available | Influenza | Biological: CAIV-T | MedImmune LLC|Wyeth is now a wholly owned subsidiary of Pfizer | Both | Child | Phase 2 | 1200 | Industry | Interventional | Allocation: Randomized|Intervention Model: Single Group Assignment|Primary Purpose: Prevention|Masking: Double-Blind | D153-P522 | September 12, 2005 | October 2002 | May 2003 | December 5, 2008 | December 2008 | No Study Results Posted | March 2003 | All episodes of AOM, occurring during the influenza season, associated with a positive culture for influenza virus antigenically similar to those contained in the vaccine.|The first episode during the influenza season of AOM associated with a positive culture for influenza virus; all episodes during the influenza season of AOM; all during the influenza season, of AOM associated with fever. | http://ClinicalTrials.gov/show/NCT00192166 | |
66 | 65 | NCT00263692 | OR NCT00263692 | Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety | Completed | No Results Available | Prophylaxis: Diphtheria, Tetanus, Pertussis, Poliovirus | Biological: Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3 | GlaxoSmithKline | Both | Child | Phase 2 | 401 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Crossover Assignment|Primary Purpose: Prevention|Masking: Open Label | 213503/047 | December 8, 2005 | November 2002 | September 2004 | June 21, 2012 | February 2012 | No Study Results Posted | September 2004 | Immunogenicity after vaccination.|Immunogenicity and safety after vaccination. | http://ClinicalTrials.gov/show/NCT00263692 | |
70 | 69 | NCT00314041 | OR NCT00314041 | Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants | Completed | No Results Available | Meningitis, Meningococcal | Biological: Meningococcal C|Biological: DTP/Hib | Wyeth is now a wholly owned subsidiary of Pfizer | Both | Child | Phase 2 | 240 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Pharmacodynamics Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double-Blind | 6029A1 D110 P500 | April 10, 2006 | June 1997 | April 1998 | February 20, 2013 | February 2013 | No Study Results Posted | April 1998 | Antibody responses to MnCC and concomitant vaccines|Safety and reactogenicity | http://ClinicalTrials.gov/show/NCT00314041 | |
72 | 71 | NCT00566527 | OR NCT00566527 | Comparative Study of Immunogenicity and Safety of a 2-Dose Regimen of ProQuad® Manufactured With rHA | Completed | No Results Available | Measles|Mumps|Rubella|Varicella | Biological: ProQuad® manufactured with recombinant Human Albumine | Sanofi Pasteur MSD | Both | Child|Adult|Senior | Phase 3 | 1260 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | MRV02C | November 29, 2007 | November 2007 | December 2008 | April 3, 2009 | April 2009 | No Study Results Posted | December 2008 | antibody response rates to measles, mumps, rubella and varicella measured at Day 42 following Dose 2|From Day 0 to Day 4 following each dose, the rates of subjects with solicited injection-site adverse reactions (injection site erythema; injection site swelling; injection site pain)|Unsolicited injection-site adverse reactions starting from Day 5 to Day 28; Systemic adverse events and rectal (or rectal equivalent) temperature ≥ 39.4°C starting from Day 0 to Day 28|The GMTs to measles, mumps, rubella and varicella; the rate of subjects with varicella antibody titres <1.25 gpELISA units/mL in subjects with baseline varicella antibody titre <1.25 gpELISA units/mL.|antibody response rates for measles, mumps, rubella (MMR) and varicella; GMTs to MMR and varicella; rate of subjects with varicella antibody titres >1.25 gpELISA U/mL in subjects with varicella antibody titre <1.25 gpELISA U/mL.|Intensity, onset, duration and relationship (for systemic adverse events only) of events; Specific description for rashes; Rectal temperature ≥38.0°C | http://ClinicalTrials.gov/show/NCT00566527 | |
73 | 72 | NCT00258895 | OR NCT00258895 | Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL® | Completed | Has Results | Diphtheria|Tetanus|Pertussis | Biological: DAPTACEL®: DTaP|Biological: DAPTACEL®: DTaP | Sanofi Pasteur, a Sanofi Company|Sanofi | Both | Child | Phase 3 | 649 | Industry | Interventional | Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | P3T11 | November 24, 2005 | March 2005 | April 2007 | January 10, 2014 | January 2014 | August 18, 2009 | December 2006 | Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination|Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination|Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination|Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.|Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination | http://ClinicalTrials.gov/show/NCT00258895 | |
76 | 75 | NCT00258700 | OR NCT00258700 | Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine | Completed | No Results Available | Haemophilus Influenzae Type b Disease|Meningococcal Serogroup Diseases | Biological: Haemophilus influenzae type b- and meningococcal (vaccine) | GlaxoSmithKline | Both | Child | Phase 3 | 478 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 103974 (primary study)|104056 | November 24, 2005 | February 2005 | July 2006 | November 3, 2011 | October 2011 | No Study Results Posted | July 2006 | 1 m after the 3rd dose of primary vaccination: SBA-MenC titre ≥ 1:8 (seroprotection status), anti-PRP concentration ≥ 0.15 µg/ml. 42 d after the booster vaccination: SBA-MenC titre ≥ 1:128, anti-PRP concentration ≥ 1 μg/ml|Antibody levels to all vaccine antigens:1 m post dose 3, prior to & 42 d post booster. After each dose: Solicited (d 0-3, local & general), unsolicited (d 0-30) & MMR specific (d 0-42) symptoms. SAEs (whole study). | http://ClinicalTrials.gov/show/NCT00258700 | |
77 | 76 | NCT01182311 | OR NCT01182311 | Duration of Long-term Immunity After Hepatitis B Virus Immunization | Completed | No Results Available | Hepatitis B | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|National Institutes of Health Clinical Center (CC) | Both | Adult|Senior | 200 | NIH | Observational | Time Perspective: Prospective | 100187|10-DK-0187 | August 13, 2010 | August 2010 | April 1, 2014 | March 2014 | No Study Results Posted | To measure anti-HBs titers and immune response in HIV positive and negative adults who were vaccinated more than 10 years ago and to compare them to individuals who spontaneously recovered from acute hepatitis B more than 10 years ago|To assess the clinical, serological and immunological response to a booster dose of hepatitis B vaccine in those individuals who did not maintain the immune response to the primary vaccination. | http://ClinicalTrials.gov/show/NCT01182311 | |||||
78 | 77 | NCT00483574 | OR NCT00483574 | Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers | Completed | Has Results | Meningococcal Meningitis|Measles|Mumps|Rubella|Varicella | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|Biological: Measles-mumps-rubella-varicella vaccine|Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV) and Hepatitis A | Sanofi Pasteur, a Sanofi Company|Sanofi | Both | Child | Phase 3 | 1378 | Industry | Interventional | Allocation: Non-Randomized|Endpoint Classification: Safety Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | MTA48 | June 6, 2007 | May 2007 | April 2009 | January 20, 2014 | January 2014 | May 10, 2011 | January 2009 | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | http://ClinicalTrials.gov/show/NCT00483574 | |
79 | 78 | NCT00370227 | OR NCT00370227 | Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine | Completed | No Results Available | Pneumococcal Disease | Biological: 10 valent pneumococcal conjugate (vaccine) | GlaxoSmithKline | Both | Child | Phase 3 | 390 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 107706 | August 30, 2006 | October 2006 | March 2007 | September 20, 2012 | September 2012 | No Study Results Posted | March 2007 | Post vacc: rectal fever >39°C|AEs/ SAEs (42 days/up to 6 mo post last vacc); prior & 42-56 days post vacc: immune response to pneumo & MMRV vaccines antigens. | http://ClinicalTrials.gov/show/NCT00370227 | |
80 | 79 | NCT00454987 | OR NCT00454987 | Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine | Completed | No Results Available | Haemophilus Influenzae Type b|Neisseria Meningitidis | Biological: Menitorix|Biological: Infanrix IPV | GlaxoSmithKline | Both | Child | Phase 4 | 288 | Industry | Interventional | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label | 109664|109666|109668 | March 30, 2007 | May 2007 | May 2010 | June 12, 2014 | September 2011 | No Study Results Posted | May 2010 | SBA-MenC titre|Anti-PRP concentration|Anti-PSC concentration.|Anti-FHA concentration|anti-PRN concentration|anti-PT concentration|All SAEs considered related to vaccination by the investigator in all subjects of groups HibMen and LicMenC.|SAEs occurring after administration of to Infanrix™ IPV and Menitorix™ vaccines to UK subjects. | http://ClinicalTrials.gov/show/NCT00454987 |