MMR - Completed - ClinicalTrials.gov | Search Date: September 24, 2014
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RankNCT Number
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TitleRecruitmentStudy ResultsConditionsInterventions
Sponsor/Collaborators
GenderAge GroupsPhasesEnrollmentFunded BysStudy TypesStudy DesignsOther IDsFirst ReceivedStart Date
Completion Date
Last UpdatedLast Verified
Results First Received
Acronym
Primary Completion Date
Outcome Measures
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3
2NCT00352898NCT00352898
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
BothChildPhase 2400IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
105909July 14, 2006April 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
3NCT00353288
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
BothChildPhase 2446IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
105908July 17, 2006March 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
6NCT00197015
OR NCT00197015
Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children
CompletedHas Results
Hepatitis A Vaccine|Hepatitis A
Biological: Havrix®|Biological: M-M-R®II|Biological: VARIVAX®
GlaxoSmithKline
BothChildPhase 31474IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
208109/231
September 13, 2005
October 2003June 2009April 11, 2013
November 2012
March 11, 2010January 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
7NCT01874457
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)
BothChild150OtherObservational
Time Perspective: Prospective
ASCLIN/002/2008
June 7, 2013May 2008August 2009June 13, 2013June 2013
No Study Results Posted
March 2009
Immunoresponse after first dose|Immunoresponse after revaccination
http://ClinicalTrials.gov/show/NCT01874457
9
8NCT00474266
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
BothChildPhase 31000IndustryInterventional
Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
109670May 15, 2007June 2007February 2008June 7, 2012February 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
10NCT00975507
OR NCT00975507
ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)
CompletedHas 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.
BothChildPhase 3480IndustryInterventional
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 1998June 1999April 29, 2014April 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
11NCT00388440
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
BothChildPhase 4150IndustryInterventional
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
13NCT00985166
OR NCT00985166
A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
CompletedHas 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.
BothChildPhase 3801IndustryInterventional
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 2000May 2003August 1, 2014August 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
14NCT00822237
OR NCT00822237
Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)
CompletedHas ResultsVaricella
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.
BothChildPhase 3598IndustryInterventional
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, 2009January 2009
December 2009
April 29, 2014April 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
15NCT00313950
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
BothChildPhase 4470IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Single Blind (Outcomes Assessor)
HAF65April 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
16NCT00263653
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
BothChildPhase 3297IndustryInterventional
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, 2014June 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
17NCT00488683
OR NCT00488683
B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants
CompletedHas Results
Meningococcal Disease
Biological: MenACWY-CRM|Biological: DTaP-Hib-IPV|Biological: PCV|Biological: MMR|Biological: Hib
Novartis Vaccines|Novartis
BothChildPhase 2216IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
V59P16|2006-003476-35
June 19, 2007July 2007June 2009
September 5, 2014
September 2014
May 30, 2013May 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
18NCT00156559
OR NCT00156559
MMR and Varicella Vaccine in Premature Infants
Completed
No Results Available
Chickenpox|Rubella|Rubeola|Mumps
University of Rochester
BothChildPhase 432OtherObservational
Time Perspective: Prospective
DMID 03-140|N01-AI-25460
September 8, 2005
January 2004May 2005June 12, 2008
September 2005
No Study Results Posted
http://ClinicalTrials.gov/show/NCT00156559
22
21NCT00871117
OR NCT00871117
Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years
CompletedHas 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
BothChildPhase 3478IndustryInterventional
Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
111852March 26, 2009March 2009January 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
22NCT00986232
OR NCT00986232
ProQuad Dose Selection Study (V221-011)(COMPLETED)
CompletedHas 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.
BothChildPhase 21551IndustryInterventional
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, 2014April 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
24NCT00406211
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
BothChildPhase 3398IndustryInterventional
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
25NCT00000815
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.
BothChildPhase 2270NIH|IndustryInterventional
Allocation: Randomized|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label
ACTG 225|11202
November 2, 1999
August 2001May 16, 2012May 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
30NCT01198574
OR NCT01198574
Sub-clinical Inflammation and Iron Supplementation
CompletedHas ResultsAnemia
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
FemaleChild|AdultPhase 3402OtherInterventional
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, 2012May 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
32NCT00262002
OR NCT00262002
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants
CompletedHas 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
BothChildPhase 2601IndustryInterventional
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 2006June 16, 2014June 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
34NCT00289783
OR NCT00289783
Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
CompletedHas 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
BothChildPhase 34441IndustryInterventional
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 2006August 2008
October 18, 2012
October 2012June 15, 2012February 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
35NCT00985153
OR NCT00985153
Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children
CompletedHas 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.
BothChildPhase 33927IndustryInterventional
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 2000May 2001April 21, 2010April 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
36NCT00474526
OR NCT00474526
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
CompletedHas 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
BothChildPhase 34545IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
V59P14May 16, 2007March 2007
November 2009
February 24, 2014
February 2014May 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
37NCT00310856
OR NCT00310856
Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)
CompletedHas Results
Meningococcal Meningitis
Biological: MenACWY-CRM|Biological: MenC-CRM|Biological: DTaP-Hib-IPV|Biological: PC7|Biological: MMR|Biological: Varicella
Novartis Vaccines|Novartis
BothChildPhase 2175IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
V59P9April 3, 2006June 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
38NCT00257127
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)
BothChild|Adult101NIHInterventional
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 2006August 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
39NCT00013871
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)
BothChild|Adult300NIHInterventional
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
42NCT00578175
OR NCT00578175
Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age
CompletedHas 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
BothChildPhase 21851IndustryInterventional
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, 2010February 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
45NCT00984295
OR NCT00984295
Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
CompletedHas 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.
BothChildPhase 31913IndustryInterventional
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, 2014August 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
48NCT00103844
OR NCT00103844
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
CompletedHas Results
Chronic Myeloid Leukemia|Philadelphia-Positive Myeloid Leukemia
Drug: Dasatinib|Drug: Imatinib
Bristol-Myers Squibb
BothAdult|SeniorPhase 2150IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Crossover Assignment|Primary Purpose: Treatment|Masking: Open Label
CA180-017
February 15, 2005
February 2005March 2008August 3, 2010June 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
49NCT00101660
OR NCT00101660
Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
CompletedHas Results
Chronic Myeloid Leukemia|Philadelphia-Positive Myeloid Leukemia
Drug: Dasatinib
Bristol-Myers Squibb
BothAdult|SeniorPhase 2387IndustryInterventional
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 2005April 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
50NCT00101816
OR NCT00101816
Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
CompletedHas Results
Chronic Myeloid Leukemia|Blast Crisis
Drug: Dasatinib
Bristol-Myers Squibb
BothAdult|SeniorPhase 2124IndustryInterventional
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 2008August 3, 2010June 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
51NCT00101647
OR NCT00101647
Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia
CompletedHas Results
Chronic Myelogenous Leukemia
Drug: Dasatinib
Bristol-Myers Squibb
BothAdult|SeniorPhase 2197IndustryInterventional
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 2008April 13, 2011April 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
52NCT00432523
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
BothChildPhase 3752IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Masking: Open Label
X04-MMRr-301
February 7, 2007
January 2005July 2006April 3, 2009April 2009
No Study Results Posted
July 2006
http://ClinicalTrials.gov/show/NCT00432523
54
53NCT00373958
OR NCT00373958
Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
CompletedHas Results
Vaccines, Pneumococcal
Biological: 13 valent pneumococcal conjugate vaccine|Biological: 7vPnc pneumococcal conjugate vaccine
PfizerBothChildPhase 3666IndustryInterventional
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 2013March 26, 2010June 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
54NCT00345683
OR NCT00345683
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
CompletedHas 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
BothChildPhase 34021IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Single Blind (Caregiver)
105988June 26, 2006July 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
55NCT00148941
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
BothChildPhase 34087IndustryInterventional
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
56NCT00871000
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
BothChildPhase 3303IndustryInterventional
Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
111815March 26, 2009April 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
58NCT00892775
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
BothChildPhase 2501IndustryInterventional
Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
108760May 4, 2009June 2009
December 2010
June 1, 2011May 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
62NCT01148394
OR NCT01148394
Enhanced Recovery After Colorectal Surgery
Completed
No Results Available
Fast Track|Enhanced Recovery
Other: Multimodal rehabilitation
University of Valencia
BothAdult|Senior119OtherInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Open Label
FT-1June 21, 2010January 2009June 2010June 21, 2010June 2010
No Study Results Posted
March 2010
Postoperative stay|Postoperative complications
http://ClinicalTrials.gov/show/NCT01148394
65
64NCT00192166
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
BothChildPhase 21200IndustryInterventional
Allocation: Randomized|Intervention Model: Single Group Assignment|Primary Purpose: Prevention|Masking: Double-Blind
D153-P522
September 12, 2005
October 2002May 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
65NCT00263692
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
BothChildPhase 2401IndustryInterventional
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, 2012February 2012
No Study Results Posted
September 2004
Immunogenicity after vaccination.|Immunogenicity and safety after vaccination.
http://ClinicalTrials.gov/show/NCT00263692
70
69NCT00314041
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
BothChildPhase 2240IndustryInterventional
Allocation: Randomized|Endpoint Classification: Pharmacodynamics Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Double-Blind
6029A1 D110 P500
April 10, 2006June 1997April 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
71NCT00566527
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 31260IndustryInterventional
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, 2009April 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
72NCT00258895
OR NCT00258895
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
CompletedHas Results
Diphtheria|Tetanus|Pertussis
Biological: DAPTACEL®: DTaP|Biological: DAPTACEL®: DTaP
Sanofi Pasteur, a Sanofi Company|Sanofi
BothChildPhase 3649IndustryInterventional
Allocation: Non-Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
P3T11
November 24, 2005
March 2005April 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
75NCT00258700
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
BothChildPhase 3478IndustryInterventional
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 2005July 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
76NCT01182311
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)
BothAdult|Senior200NIHObservational
Time Perspective: Prospective
100187|10-DK-0187
August 13, 2010
August 2010April 1, 2014March 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
77NCT00483574
OR NCT00483574
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
CompletedHas 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
BothChildPhase 31378IndustryInterventional
Allocation: Non-Randomized|Endpoint Classification: Safety Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
MTA48June 6, 2007May 2007April 2009
January 20, 2014
January 2014May 10, 2011January 2009
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.
http://ClinicalTrials.gov/show/NCT00483574
79
78NCT00370227
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
BothChildPhase 3390IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
107706
August 30, 2006
October 2006March 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
79NCT00454987
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
BothChildPhase 4288IndustryInterventional
Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Prevention|Masking: Open Label
109664|109666|109668
March 30, 2007May 2007May 2010June 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
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