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Live total number of trial participants10,282,104Live total number of trials1,681Live total trials by control typePlacebo - inert591Placebo adjuvant619Placebo-adjuvant161Active control - same-disease vaccine418Active control - unrelated-disease vaccine196Other30No-intervention18Placebo unknown70Placebo excipient195
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Record IDVaccineYear (published)PopulationN (vax)N (control)Control TypeComparator Type EFFICACYComparator SAFETY INERTComparator Type EFFICACYControl Group (specify if placebo)Review StatusReviewer InitialsReview NotesOutcome TypePrimary OutcomeResult SummarySafety OutcomePMID / DOILinkNotes (See WHO placebo-ethics guidance (PMC4157320) in guidelines doc)
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RCT015Bacillus anthracis vaccine (AV7909)2016Healthy adults 18–65 years of age10521Active ControlActive control – same-disease vaccineNoLicensed anthrax vaccine (BioThrax)Review CompleteADSafety & ImmunogenicityTo evaluate the safety, tolerability, and immunogenicity of different doses and schedules of AV7909 compared to the licensed BioThrax vaccine.AV7909 elicited a more rapid and robust antibody response compared to the licensed BioThrax vaccine. A two-dose AV7909 regimen was non-inferior to a three-dose BioThrax regimen.The vaccine was well-tolerated. Local reactions such as tenderness and pain were more frequent with AV7909 than with the comparator, but most were mild to moderate. No deaths or withdrawals due to adverse events occurred.26979136PubMed
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RCT018Bordetella pertussis (CP5DT/CP5) 1994Children 17 m - 6 y 6870Active ControlActive control – same-disease vaccineNoCP4DT/CP4 vaccines Review CompleteADSafety & ImmunogenicityImmune responseImmune response was observed for all antigens among groupsNo severe adverse events were reported 7910089PubMed
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RCT019Bordetella pertussis (DTaP 25ug or 8ug) 1994Children 10-16 w 200101Active ControlActive control – same-disease vaccineNoDTwP vaccine Review CompleteADSafety & ImmunogenicityImmune response Immune response was similar among acellular component vaccinees (96% vs 94%) More local adverse events and fever was present in DTwP group8165852PubMed
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RCT020Bordetella pertussis (DTaP PRP-T) 1999Children 2-3 m 360357Active ControlActive control – same-disease vaccineNoDTwP PRP-TReview CompleteADSafety & ImmunogenicityImmune response and surveillance of adverse events Higher antibody titers were present in DTaP groupsDTwP had higher rate of adverse events 10195774PubMed
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RCT021Bordetella pertussis (DTaP)1993Children 17m-5y108107Active ControlActive control – same-disease vaccineNoDTwP vaccineReview CompleteADSafety & ImmunogenicityImmune response to pertussis components DTaP had higher induced antibody titters DTaP had fewer local and systemic adverse eventsDTaP had fewer local and systemic adverse events8335014PubMed
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RCT022Bordetella pertussis (DTaP)1990Children 17-24 m 3837Active ControlActive control – same-disease vaccineNoDTwP vaccine Review CompleteADSafety & ImmunogenicitySurveillance of adverse events and seroresponse Seroresponse was better for DTaP group in pertussis components.More local adverse events were present in DTwP group. 2196360PubMed
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RCT023Bordetella pertussis (DTaP)1992Children 17-24 m 34352Active ControlActive control – same-disease vaccineNoDTwP vaccine Review CompleteADSafety & ImmunogenicityImmune reponse to pertussis component Immune reponse was significant and similar among vaccines; differences were just observed for FHA, favouring DTaPLocal side effects were more frequent in DTwP1528643PubMed
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RCT024Bordetella pertussis (DTaP)1993Children 15-20 m 16482Active ControlActive control – same-disease vaccineNoDTwP vaccine Review CompleteADChanged from placebo to active controlSafety & ImmunogenicityImmune response against pertussis components; immune response against tetanus and diphteria toxoids.Antibody titers were observed in DTaP groupDTaP had fewer local and systemic reactions. 8438810PubMed
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RCT025Bordetella pertussis (DTaP)1994Children 2-6 m 236236Active ControlActive control – same-disease vaccineNoDTwP vaccine Review CompleteADSafety & ImmunogenicitySurveillance of adverse events and seroresponse Both vaccines devoleped adequate immune response to all vaccine componentsNo severe adverse events were reported. Local adverse events were more frequent in DTwP group. 8201477PubMed
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RCT026Bordetella pertussis (DTaP)1996Children 2-6 m141145Active ControlActive control – same-disease vaccineNoDTwP vaccine Review CompleteADSafety & ImmunogenicityImmune response and surveillance of adverse eventsAdequate immune response was observed for more than 90% among vaccinees for pertussis component. Less adverse events were observed in DTaP group 9031875PubMed
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RCT027Bordetella pertussis (DTaP)1998Children 2-18 m 4,2734,259Active ControlActive control – same-disease vaccineNoDTwP vaccine Review CompleteADEfficacy & SafetyMild and typical pertussis VE 72% vs 83% Severe adverse events were rare but more frequent in DTwP group9417143PubMed
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RCT028Bordetella pertussis (DTaP) 1994Children 15-20 m 11055Active ControlActive control – same-disease vaccineNoDTwP vaccine Review CompleteADSafety & ImmunogenicitySeroresponse to pertussis component and surveillance of adverse events Higher immune response was observed in DTaP DTaP had fewer local and systemic side effects8134224PubMed
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RCT031Bordetella pertussis (DTwP)1997Children 2-6 m2,0922,089Active ControlActive control – same-disease vaccineNoDTaP vaccine Review CompleteADEfficacy & SafetySurveillance of adverse events and Pertussis disease. VE against pertussis was 31% for DTaP and 55% for DTwP; and 85% vs 96% VE against severe disease.No significant difference in severe adverse events was reported (0.03% vs 0.03%)9364690PubMed
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RCT035Bordetella pertussis (pertussis toxoid 10 mcg) 1995Children 6-12 w2911,759Active ControlActive control – same-disease vaccineNoPertussis toxoid 20 mcg Review CompleteADSafety & ImmunogenicityImmune response and surveillance of adverse eventsHigher antibody titers were present in 20 mcg vaccine groupLocal adverse events were present in 3-6%. No differences in adverse events. 8539554PubMed
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RCT036Bordetella Pertussis (Toxoid; one component)1987Children 5-10 m128127Active ControlActive control – same-disease vaccineNoPertussis toxoid two componentReview CompleteADSafety & ImmunogenicitySurveillances of adverse events; seroresponse. No differences in seroconversion. Comparator group had higher antibody titres than the two component vaccine group.No differences in reported systemic side effects were observed. Local adverse events were more frequent in the two component vaccine. 3307386PubMed
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RCT037Borrelia burgdorferi - Lyme disease (OspA vaccine; 15 ug)1999Children 5-15 y 125125Active ControlActive control – same-disease vaccineNoSame vaccine; 30 ug/dose Review CompleteADSafety & ImmunogenicitySurveillance of adverse events and seroconversion Seroconversion was present in 99% among groupsNo difference in reported adverse events. 10547245PubMed
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RCT041Borrhelia burgdorferi - Lyme disease (OspA, 30 ug dose) 2014Adults 18-70y176174Active ControlActive control – same-disease vaccineNoOspA vaccine 60 ug Review CompleteADImmunogenicitySeroresponse to OspA and surveillance of adverse events Seroresponse was dose dependentAdverse events were mild and transcient; no differences among groups 25185574PubMed
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RCT046Chikungunya (PXVX0317)2022Adults, 18–45 y (USA)4150 (see note)Active ControlActive control – same-disease vaccineNoDiffering formulations (see note)Review CompleteADSafety & ImmunogenicitySerum neutralising antibody GMT at day 57 (28 days post-final dose)PXVX0317 (adjuvanted or unadjuvanted) induced 100% seropositivity by day 57; 40 µg single dose and booster dose showed durable responses up to 2 yearsMost adverse events were mild or moderate (injection site pain, headache, myalgia); no vaccine-related serious adverse events 12 SAEs total.35709798PubMed10.1016/S1473-3099(22)00226-2. Group 1 received two doses of unadjuvanted PXVX0317 28 days apart (2 × 20 μg; standard); all other groups received adjuvanted PXVX0317: groups 2–4 received two doses 28 days apart (2 × 6 μg [group 2], 2 × 10 μg [group 3], or 2 × 20 μg [group 4]; standard); group 4 also received a booster dose 18 months after the first active injection (40 μg; standard plus booster); groups 5–7 received two doses 14 days apart (2× 6 μg [group 5], 2 × 10 μg [group 6], or 2 × 20 μg [group 7]; accelerated); and group 8 received one dose (1 × 40 μg; single).
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RCT069Cholera (BBV131, Hillchol)2025Healthy individuals >1yo w/ no prior vaccination1,350450Active ControlActive control – same-disease vaccineNoShancholReview CompleteADSafety & Immunogenicity>4-fold increase in vibriocidal antibody titresBBV131 demonstrates non-inferior immunogenicity and comparable safety to ShancholAEs similar between groups. Most common dry mouth, mouth pain, nausea, fever40174256PubMed
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RCT098Cholera (Whole vibrios and B subunit toxin)1989Male adults 1112Active ControlActive control – same-disease vaccineNoSame vaccine; lower doseReview CompleteADImmunogenicitySeroresponse. Both groups had appropiate seroresponse. No adverse events were reported.2909484PubMed
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RCT147Dengue (TAK-003 lyophilized formulation) 2020Adults 18-49 y 603399Active ControlActive control – same-disease vaccineNoTAK-003 liquid formulation Review CompleteADImmunogenicityImmune response and surveillance of adverse events. Immunologic equivalence was only shown for DENV-2 No severe vaccine related adverse events were reported 32119591PubMed
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RCT149Dengue (TAK-003, high vs. low dose)2020Adults, 21–45 y (Singapore)175176Active ControlActive control – same-disease vaccineNoHigh-dose (early formulation) tetravalent dengue vaccine (TAK-003)Review CompleteADSafety & ImmunogenicityNeutralizing antibody GMTs against DENV-1/2/3/4TDV formulation elicited balanced immune response, lower DENV-2 GMT but higher DENV-4 GMT vs HD-TDV; peak GMTs at Day 30.Similar AE rates between groups, mostly mild/moderate; 6 total SAEs (no deaths) including 1 vaccine-related SAE (polyarthritis) in HD-TDV.31843269PubMed10.1016/j.vaccine.2019.11.061. Randomized to an early formulation, referred to as HD-TDV, and a new formulation with 10-fold lower serotype 2 potency, referred to as TDV
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RCT150Dengue (TAK-003, lower dose) 2019Adults 21-45 y175176Active ControlActive control – same-disease vaccineNoTAK-003Review CompleteADSafety & ImmunogenicityImmune response and surveillance of adverse events Both groups showed immune response. Adverse events frequency was not different among groups31843269PubMed
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RCT167Dengue virus (tetravalent/TDV)2009Adults710Active ControlActive control – same-disease vaccineNoDifferent doses of same vaccineReview CompleteADSafety & ImmunogenicityNeutralizing antibody titer 1 month after second vaccination36%, 40% and 63% of vaccinated subjects seroconverted (formulations 13, 14 and 17 respectively)75%, 31% and 31% swere viremic on day 10 (formualtions 13,14 17 respectively). No serious adverse events18670195PubMed
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RCT168Dengue, CYD-TDV2013Adults, 18-45 (USA)2600 (see note)Active ControlActive control – same-disease vaccineNoDiffering formulations (see note)Review CompleteADSafety & ImmunogenicityCompare neutralizing antibody responses (PRNT50) after two doses (0 and 6 months) of 5555 vs. 5553 formulations.Both produced high responses to serotypes 1-3. 5555 produced a better response to serotype 4.Well tolerated; adverse events similar between groups; no vaccine-related serious adverse events. SAEs were 3% or less in all groups.24021313PubMedRandomized to receive one of the following three formulations: CYD-TDV 5555 (≈5 log10 tissue culture infectious dose 50% [TCID50] of serotypes 1–4); CYD-TDV 5553 (≈5 log10 TCID50 of serotypes 1–3 and ≈3 log10 TCID50 of serotype 4); and CYD-TDV 4444 (≈4 log10 TCID50 of serotypes 1–4). CYD-TDV batch numbers were: 5555 formulation, S4168 and S4237; 5553 formulation, S4161; 4444 formulation, S4160. All three formulations were administered by subcutaneous injection, in the deltoid region of the arm.
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RCT169Difteria Tetanus Pertussis (DTaP 12.5-25 mcg) 1992Children 15-24 m and 4-6 y 6836Active ControlActive control – same-disease vaccineNoDTwP vaccineReview CompleteADSafety & ImmunogenicitySeroresponse to pertussis component No difference between groups More adverse events were reported in DTwP group 1539456PubMed
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RCT170Difteria Tetanus Pertussis (DTP 10 Lf units)1991Children 4-5 y124126Active ControlActive control – same-disease vaccineNoDTP 25 Lf unitsReview CompleteADChanged Comparator SAFETY INERT to NoSafetyLocal adverse eventsLocal adverse events were more frequent in control group (71% vs 52%) favouring modified vaccine.Reported as main outcome1893319PubMed
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RCT171Diphteria Tetanus Pertursis (DTP reduced dose) 1984Children 2-18 m 4139Active ControlActive control – same-disease vaccineNoDTP standard dose vaccineReview CompleteADSafety & ImmunogenicitySurveillance of adverse events. Seroresponse.Seroresponse was observed in 97-6% vs 97.3%Temperature >39.0º was observed in 2.9% vs 10.0%; behavior change was seen in 17% in both groups. Local reactions were observed 58.5% vs 72.6%. 6747752PubMed
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RCT172Diphteria Tetanus Pertusis (Acellular and Whole Cell) 1988Children, age not specified1920Active ControlActive control – same-disease vaccineNoDTwP vaccineReview CompleteADSafety & ImmunogenicitySeroconversion and adverse eventsAntibody titers were higher in DTP-WC group.Fewer adverse events were reported in DTP-AC group. 2894399PubMed
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RCT173Diphteria Tetanus Pertussis (Acellular/Whole Cell) 1986Children 18-24 m2040Active ControlActive control – same-disease vaccineNoDTwP vaccineReview CompleteADSafety & ImmunogenicityReactogenicity and adverse eventsAntibody response to all vaccine components were comparable between groups.Reactions over 48 hours were significantly less common in acellular pertussis component group. 2874738PubMed
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RCT174Diphteria Tetanus Pertussis (BIKEN DTaP vaccine) 1992Children 4-6 y 24076Active ControlActive control – same-disease vaccineNoDTwP vaccineReview CompleteADSafety & ImmunogenicitySerorespone (≥4 fold antibody response)Seroresponse was higher in DTaP group (90% vs 55%)Systemic reactions were more frequent in DTwP group. 1621656PubMed
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RCT175Diphteria Tetanus Pertussis (DTaP Takeda + DT Lederle's)1992Children 2-6 m 5050Active ControlActive control – same-disease vaccineNoDTaP Takeda vaccineReview CompleteADSafety & ImmunogenicitySurveillance of adverse events and immune response Immune response was better at 7 months for study group in the Pertussis component.No severe adverse events due to vaccination were observed among groups1454434PubMed
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RCT176Diphteria Tetanus Pertussis (DTPaP) 1993Children 2-6 m 2288Active ControlActive control – same-disease vaccineNoDTwP vaccine Review CompleteADSafety & ImmunogenicitySeroresponse and surveillance of adverse eventsHigher antibody response for Pertussis was present in DTaP group; No differences in immune response for diphteria or tetanus toxoids.Adverse events were less frequent in DTaP 8438811PubMed
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RCT177Diphteria Tetanus Pertussis (DTwP)1991Children ≥2 m 252245Active ControlActive control – same-disease vaccineNoDTaP vaccine Review CompleteADSafety & ImmunogenicitySpeciffic immune response to Pertussis componentDTaP has equivalent immune response than DTwPMore adverse events were reported in DTwP group 1907317PubMed
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RCT178Diphteria Tetanus Pertussis (DTwP)1994Children 2-4 m 7475Active ControlActive control – same-disease vaccineNoDTaP vaccine Review CompleteADSafety & ImmunogenicitySeroresponseBetter specific immune response was observed for the acellular vaccine.In general, mild adverse events were reported; DTwP group had more reported events 8303945PubMed
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RCT179Diphteria Tetanus Pertussis (Reformulated DTwP)1997Children 604208Active ControlActive control – same-disease vaccineNoDTPw (Triple Antigen vaccine) vaccineReview CompleteADSafety & ImmunogenicitySeroresponse and surveillance of adverse events. Reformulated vaccine had appropiate immune response compared to comparatorStudy group had fewer local adverse events than comparator. 9401885PubMed
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RCT180Diphteria, Tetanus, Pertussis (DTwP-Local) 2013Children 4-6 y 337335Active ControlActive control – same-disease vaccineNoDTwP-Pasteur vaccineReview CompleteADSafety & ImmunogenicityImmune response Higher pertussis immune response was elicited in comparator group; tetanus and diphteria immune response was similar. Adverse events were more frequent in study group. 23442608PubMed
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RCT183Diphtheria + tetanus-acellular pertussis (DTaP) vs. Diphterhia-tetanus boost 8-12 years after initial vaccine2019Adults 18-65 who had been immunized with DTaP 8-12 years earlier1,002328Active ControlActive control – same-disease vaccineNoActive Unrelated VaccineBoost with Diphtheria-Tetanus vaccineReview CompleteADSafety & ImmunogenicityAntibody titersAntibody titers to pertussis higher with the boost containing acellular pertussisNo difference in adverse events29438562PubMed
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RCT184Diphtheria + tetanus-acellular pertussis, (Adacel)2005Adolescents/adults 11-64 y3,0531,427Active ControlActive control – same-disease vaccineNoTetanus-diphtheria vaccine (Td)Diphtheria-Tetanus vaccineReview CompleteADSafety & ImmunogenicitySeroprotection (0.1 IU/mL or greater)Seroprotection ranged from 94.1-100% in the treatment group vs. 95.1-100% among controls.Safety and reactogenicity evaluation outcomes were comparable between the Tdap and Td groups for both the adolescent and adult populations.15933223PubMeddoi:10.1001/jama.293.24.3003
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RCT185Diphtheria + tetanus-pertussis - DTP (three different components) vs. DT19960 - 6 months7,2552,574Active ControlActive control – same-disease vaccineNoActive Unrelated VaccineDiphtheria-Tetanus vaccineReview CompleteADEfficacy & SafetyPertussis linked to laboratory-confirmed case of pertussis or contact with an infected household member with paroxysmal cough for > or = 21 daysVE 58.9%for the two-component vaccine (95% CI, 50.9 to 65.9%), 85.2% for the five-component vaccine (95% CI, 80.6 to 88.8%), and 48.3% for the whole-cell vaccine (95% CI, 37.0 to 57.6%). The rates of adverse events among children who received an acellular pertussis vaccine and those who received the control DT vaccine with no pertussis component were similar. The acellular vaccines were much less likely to cause reactions than the whole-cell vaccine8538705PubMed
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RCT186Diphtheria + tetanus-pertussis 2, 3, or 5-component acellular vaccines vs. DTP whole cell vaccine1997Children 3-12 months62,17220,720Active ControlActive control – same-disease vaccineNoActive Unrelated VaccineDTwP vaccineReview CompleteADEfficacyRates of pertussis over a mean of 22 months of follow upThe 2 and 3 component pertussis vaccines were less effective than the 5 component and whole cell vaccines: pertussis rates 0.00583, 0.00329, 0.00224, and 0.00180 per year for 2, 3, 5 component, and whole cell vaccinesNo difference in rates of AEs across the vaccine groups.9393335PubMed
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RCT187Diphtheria-tetanus-whole cell pertussis (DTP original) vs. DT-acellular pertusiss (DTaP) 198940 children 4-6 y, 40 children 18-24 mo, 50 children 2,4,6 mo6268Active ControlActive control – same-disease vaccineNoActive Unrelated VaccineOriginal DTP vaccineReview CompleteADSafety & ImmunogenicityAntibody titersAntibody titers significantly higher with the DTaP vaccine, and adverse effects significantly lower with the DTaP vaccineCompared with conventional vaccine, acellular vaccine was significantly associated with reduced frequency of leg pain and fretfulness at all ages and less frequent fever and anorexia at some ages2809258PubMed
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RCT188Diphtheria–tetanus toxoids–acellular pertussis 5, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b (DTaP5–HB–IPV–Hib)2017Healthy infants 46–74 days of age628622Active ControlActive control – same-disease vaccineNoInfanrix-hexa (DTPa3–HBV–IPV/Hib)Review CompleteADImmunogenicityevaluate and compare the immunogenicity of DTaP5–HB–IPV–Hib to Control immune responses to vaccine antigens were noninferior in the DTaP5–HB–IPV–Hib group vs ControlsAEs similar between groups. Most were mild/mod and didn't lead to medical intervention. 4 pts in control group d/c 2/2 vaccine related AEs. 2.8% of participants in the DTaP5–HB–IPV–Hib group and 2.2% of Control group reported at least 1 SAE. No deaths.27846055PubMedSecondary goal was to evaluate the immunogenicity of MMRV when administered concomitantly with the toddler dose of DTaP5–HB–IPV–Hib or Control. The DTaP5–HB–IPV–Hib group responses to MMRV given concomitantly at 12 months were all noninferior compared with the Control group
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RCT189Diphtheria, tetanus, Bordetellla pertussis, Polio (dTpa (Boostrix), dTpa-IPV (Boostrix-IPV), or Td (Ditantrix Adult or Tedivax pro adulto)2007Adults ≥40 years with >20 years since last Td dose (or unknown vaccine history)
(Europe)		307153Active ControlActive control – same-disease vaccineNoTetanus-diphtheria toxoid vaccineReview CompleteADSafety & ImmunogenicityImmunogenicity as measured by antibody titers; local and systemic reactions to vaccination>92% antibody response for diphtheria, tetanus, pertussiss, and polio antibodies regardless of receipt of 3 dTpa doses, one dose of dTpa-IPV + 2 doses of Td, or 3 doses of Td. No difference between groups in either local or systemic reactions. No severe AEs reported. 17897485PubMed
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RCT190Diphtheria, tetanus, pertussis (Vero cell cultured, DTaP_IPV(Vero), serum-free) combined with Haemophilus influenze type B2008Healthy infants between 28 and 49 days old410407Active ControlActive control – same-disease vaccineNoDTaP-IPV(Mkc)Review CompleteADSafety & ImmunogenicityDemonstrate the noninferiority as regards simultaneous seroprotection against poliovirus types 1, 2 and 3 (immunogenicity)DTaP-IPV(Vero) was noninferior to DTaP-IPV(Mkc). All antibody concentrations/titres remained at an acceptable level from the end of the primary vaccination series (i.e. 2, 3.5 and 5 months) until the time of the booster vaccination at 16 months.No vaccine-related serious adverse events and no injection site granulomas or swelling of the entire thigh occurred. The frequencies of local injection site erythema and swelling as well as systemic adverse events such as fever, irritability, somnolence and decreased appetite were low and acceptable in both treatment groups.18675870PubMed
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RCT191Diphtheria, tetanus, pertussis (whole cell pertussis vaccine, GSK investigational) combined with Haemophilus influenze type B and hepatitis B virus2006Healthy infants750250Active ControlActive control – same-disease vaccineNo(DTwP-HB-Hib) Vs (DTwP-HB) + HibReview CompleteADSafety & ImmunogenicitySafety reactions. Immune responseThe combined DTPw-HB/Hib vaccine was non-inferior to the licensed vaccines in terms of seroprotection/seropositivity/vaccine response rates for all antigen components.Both vaccine regimens were similar in terms of their overall reactogenicity profiles. 16640847PubMed
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RCT192Diphtheria, tetanus, pertussis (whole cell pertussis vaccine, GSK investigational) combined with Haemophilus influenze type B and hepatitis B virus2010Healthy children 6 to 10 weeks of age439146Active ControlActive control – same-disease vaccineNoTritanrix-HBV/HibReview CompleteADSafety & Efficacy & ImmunogenicityNon-inferiority of the DTPw-HBV/Hib vaccine to Tritanrix-HBV/Hib based on antibody response one month after the third
primary vaccine dose.		DTPw-HBV/Hib vaccine was non-inferior to Tritanrix-HBV/Hib in terms of seroprotection/vaccine response rates for all component antigens; persistence of antibodies against all vaccine antigens was comparable between groups. Both vaccines were generally well-tolerated as primary and booster doses.Incidence of solicited local and general symptoms following any dose.20950456PubMed
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RCT193Diphtheria, tetanus, pertussis (whole cell pertussis) in combination with hepatitis B virus2007Health infants aged 11 to 17 weeks78141Active ControlActive control – same-disease vaccineNoTritanrix-HBV or Triple Antigen + Engerix-BReview CompleteADSafety & ImmunogenicityDemonstrate non-inferiority ofthe candidate DTPw-HBV vaccine as compared to concomitantadministration of Triple Antigen™ + Engerix™-B with respect to the antibody response to the Pw antigen after a three-dose primary vaccination course (immunogenicity)Non-inferiority, in terms of the anti-BPT antibody response, of the new DTPw-HBV vaccine versus TripleAntigen™ + Engerix™-B was demonstratedIncidence of solicited local and general adverse events(any or grade 3 intensity, or events followed by a visit to a medical practitioner) was calculated. 10 subjects (2 in DTPw-HBV, 7 in Tritanrix-HIV, 1 in Triple Antigen + Engerix-B groups) experiences severe adverse events. Only 1 SAE was considered to be related to vaccination and subject was withdrawn from the study (gastritis).17404515PubMed
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RCT194DTwP-Hib-CRM197 (dose-finding)2005Infants 6–14 wk (Vietnam)66195Active ControlActive control – same-disease vaccineNoLicensed DTwP-Hib-CRM197 (Quinvaxem)Review CompleteADImmunogenicityAnti-PRP >= 0.15 µg/mL 1 mo after Dose 3All three lower-dose formulations non-inferior to licensed dose; seroprotection >= 95%.Local pain mild; no vaccine-related SAEs.15705477PubMed
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RCT925Ebola virus (Ad26.ZEBOV and MVA-BN-Filo)2023Infants aged 4–11 months (recruited in Guinea and Sierra Leone)7433Active ControlActive control – same-disease vaccineNoTwo doses of a meningococcal quadrivalent conjugate vaccine (administered 56 days apart)Review CompleteADChanged Comparator SAFETY INERT to No, NCT03929757Safety & Immunogenicityreactogenicity/safety outcomesThe Ad26.ZEBOV–MVA-BN-Filo regimen induced strong humoral responses in infants (GMCs reported ~27,700 EU/mL for 4–8-month-olds and ~20,481 EU/mL for 9–11-month-olds at 21 days post-dose 2) with 100% responder rate in vaccine arm (74/74), while control group titres were below quantification and responder rate was low (1/33).well tolerated with no safety concerns related to vaccination in this infant population.37858585PubMed
the trial used a sentinel 1:1 allocation for initial infants then a 5:2 allocation for the rest
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RCT221Ebola, Ad26.ZEBOV + MVA-BN-Filo2016Adults, 18-50 y (UK)720 (see note)Active ControlActive control – same-disease vaccineNoSaline solution (as boost in 12 patients)Review CompleteADSafety & ImmunogenicityNumber of participants with an adverse event (safety), % response (immunogenicity)45/60 (75%) patients randomized to vaccine with vaccine boost responded, compared to 1/12 (8.3%) randomized to vaccine with placebo boost.51/60 (85%) patients in the vaccine with vaccine boost groups had any adverse event compared to 8/12 (67%) in the vaccine with placebo boost groups. Local/systemic AEs mild to moderate; transient neutropenia post-Ad26.ZEBOV; no significant safety signals. 4 unrelated SAEs total.27092831PubMedPatients were randomized to 1 of 2 vaccinces and then either a boost or placebo on day 29 or 57 (8 groups total). Intervention: 2 with MVA-BN-Filo as prime vaccine on day 1 boosted by Ad26.ZEBOV on day 29 or day 57 and 2 with a priming dose of Ad26.ZEBOV boosted by MVABN-Filo on day 29 or day 57.
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RCT223Enterotoxigenic E. coli (ETEC) - Diarrhea 2013Healthy adults aged 19 to 46 years old3920Active ControlActive control – same-disease vaccineNoSame innoculum, different E. coli strain (1st generation ETEC vaccine)Review CompleteADSafety & ImmunogenicityImmungenicity of two different doses of the prototype vaccine with that of the 1st generation vaccine.The prototype inactivated whole-cell ETEC vaccine given in two oral doses was safe, well tolerated, and induced strong mucosal and systemic antibody responses, particularly against LTB, with responses generally higher at increased bacterial doses. Immune responses to CFA/I were more modest, but overall the vaccine demonstrated dose-dependent immunogenicity and results support continued development of a multivalent formulation with an adjuvant for broader protection.No serious adverse events occurred in any of the volunteers. Among the total 119 AEs recorded, 33 were deemed to be possibly or probably related to immunization (Table 2); among these, most (28) were of gastrointestinal origin. 23306362PubMed
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RCT240Enterovirus 71 (inactivated vaccine: Sinovac EV71)2021Children (older cohort) 36–71 months (trial also included 6–35 months group for bridging)600300Active ControlActive control – same-disease vaccineNoEV71 vaccineReview CompleteADSafety & ImmunogenicityNon-inferiority of immunogenicity (seroconversion/GMT) of Sinovac EV71 in older children vs control EV71 vaccine (and bridging vs younger cohort); safety endpoints measured as secondary/important outcomes.The Sinovac EV71 vaccine met non-inferiority (and in some comparisons superiority) criteria — seroconversion and GMTs in Older-S were similar or superior to Older-C; safety profiles were similar across groups.Incidence of adverse reactions was similar between groups (no major safety signals reported).33269798PubMed
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RCT251Escherichia coli ( FimCH (antigen) and Phosphorylated HexaAcyl Disaccharide (PHAD®; adjuvant).)2021Women 21 - 64 years625Active ControlActive control – same-disease vaccineNoVaccine Vs vaccine + adjuvant, different dosesReview CompleteADSafety & Immunogenicitysafety, tolerability, and immunogenicity of different dosages of the antigen and adjuvant of the vaccine.The vaccine induced both binding and functional antibodies. The women with histories of recurrent UTI demonstrated greater than 150-fold increases in antibodies against the N-terminal region of FimH.All dosages were well-tolerated and a low incidence of systemic reactions occurred. No serious adverse events related to the vaccine were reported. 33325785PubMed
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RCT275Haemophilus influenzae b2004Adults, 64-92 y1250 (see note)Active ControlActive control – same-disease vaccineNoDiffering formulations (see note)Differing formulations (see note)​Safety & ImmunogenicityIgG1 and IgG2 response to vaccinationIgG1 response ranged from 17.6-39.6%. IgG2 response ranged from 6.4-22.7%.No significant local or systemic adverse events were noted for any of those vaccinated. Pain at the injection site was the most commonly reported reaction15507066PubMeddoi:10.1111/j.1532-5415.2004.52511.x. Group 1 (n=39), PRP; Group 2 (n=44), PRP conjugated to an outer-membrane protein complex of Neisseria meningitidis (PRP-OMP); and Group=3 (n=42), PRP conjugated to diphtheria toxoid (PRP-D). Group 1, unconjugated PRP (National Institute of Allergy and Infectious Disease, Bethesda, MD); Group 2, PRP conjugated to an outer-membrane protein complex of Neisseria meningitidis (PRP-OMP; PedVaxHib, Merck and Co., Whitehouse Station, NJ); and Group 3, PRP conjugated to diphtheria toxoid (PRP-D; ProHibit, Aventis Pasteur, Swiftwater, PA).
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RCT276Haemophilus influenzae b2001Infants 2–6 mo300300Active ControlActive control – same-disease vaccineNoFull-dose PRP-T Hib​ImmunogenicityAnti-PRP IgG GMC 1 mo after Dose 3All fractional-dose regimens met seroprotection criteria; GMCs 11–16 µg/mL; >=90% achieved >=1.0 µg/mL.No notable safety issues reported.11220764PubMedPaywalled; but now downloaded. Dose-comparison study.
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RCT277Haemophilus influenzae b -MenC-TT booster2008Toddlers 12–15 mo (UK)359117Active ControlActive control – same-disease vaccineNoSeparate Hib + MenC vaccines​ImmunogenicityPost-booster PRP GMC & MenC SBA >= 8PRP GMC 26 µg/mL vs 7 µg/mL; MenC SBA >= 8 in 98% vs 94%.Well tolerated; local pain only.18463125PubMed
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RCT284Haemophilus influenzae type b (PRP OMP) 1995Children 2-15 m 14696Active ControlActive control – same-disease vaccineNoH. influenzae (CRM197) ​Safety & ImmunogenicitySurveillance of adverse events Seroresponse Significant seroresponse was observed among groupsNo differences in reported adverse events were observed between groups. 7869554PubMed
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RCT285Haemophilus influenzae type b conjugate vaccine (PRP-T)2017Healthy infants (6 weeks of age) in Argentina121120Active ControlActive control – same-disease vaccineNoLicensed Haemophilus influenzae type b conjugate vaccine (Act-HIB)​Safety & ImmunogenicityImmunogenicity: Non-inferiority of the immune response (anti-PRP antibody geometric mean concentrations) one month after the primary vaccination series compared to the licensed control vaccine.The investigational Hib vaccine (PRP-T) was non-inferior to the licensed Hib vaccine (Act-HIB) in terms of immunogenicity, inducing a robust antibody response after the primary series and a strong booster response. The safety and reactogenicity profiles of the two vaccines were comparable.The vaccine had a safety profile similar to the licensed comparator vaccine. Rates of solicited and unsolicited adverse events were comparable between the two groups. No vaccine-related serious adverse events were reported.36722147PubMed
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RCT286Haemophilus influenzae type b Hib (PRP-CRM197)2016Children, 3-6 months (Japan)278138Active ControlActive control – same-disease vaccineNoStandard Hib vaccine (PRP-T)​Safety & ImmunogenicityNon-inferiority of anti-PRP IgG and seroprotectionSeroprotection: 99.3% with PRP-CRM197 and 95.6% with PRP-T. Non-inferior short term IgG response as well (100% each).Mild and serious AEs occurred in similar rates between groups, respectively. No deaths.27265451PubMed10.1016/j.vaccine.2016.05.050. PRP-CRM197 vaccine consists of 10 mcg of PRP conjugated to a non-toxic mutant of diphtheria toxoid—diphtheria cross reactive material, (CRM197)—and contains 0.3 mg of aluminum phosphate adjuvant (VAXEMTM Hib). PRP-T vaccine consists of 10 mcg of PRP conjugated to tetanus toxoid(ActHIB).
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RCT293Hepatitis A (HM175 strain vaccine)1992Medical students and staff volunteers 16142Active ControlActive control – same-disease vaccineNoCLF virus strain; HAV vaccineReview CompleteADSafety & ImmunogenicitySeroconversion (anti-HAV) Seroconversion was present in the 100% of vaccinees1 severe adverse event was reported; consisting of 4 days of fever1335638PubMed
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RCT298Hepatitis A (Healive +/- Havrix), 3 treatment groups2012Children, 1.5–6 y (China)22776Active ControlActive control – same-disease vaccineNoHavrix (licensed inactivated HAV)Review CompleteADSafety & ImmunogenicitySeroconversion at 6 months100% seroconversion with Healive vs. 80.2% Havrix (P<0.001)Mild, rare systemic events; no significant local reactions. Most AEs resolved with 24-48 hours.22537990PubMed10.1016/j.vaccine.2012.04.038. Randomized into groups A, B, C and D. Group A received two doses of Healive, group B received one dose of Healive and a booster dose of Havrix, group C received one dose of Havrix and a booster dose of Healive, and group D received two doses of Havrix.
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RCT299Hepatitis A (Healive)2008Healthy children 1–8 y (China)300100Active ControlActive control – same-disease vaccineNoHavrix™ vaccineReview CompleteADImmunogenicityAnti-HAV seroconversion at 7 mo100% seroconversion in both groups; Healive induced higher GMTs than Havrix.No notable safety differences; mild local reactions only.18395305PubMed
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RCT300Hepatitis A (inactivated, 3 lots)2008Children 1–8 y (China)318106Active ControlActive control – same-disease vaccineNoHavrix™ 720 ELUReview CompleteADImmunogenicityAnti-HAV seroconversion 30 d after Dose 2Seroconversion >=97% for all three lots; GMTs equivalent; non-inferior to reference lot.Local soreness mild; no vaccine-related SAEs.19040036PubMedArticle in chinese
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RCT302Hepatitis A booster (Avaxim vs Vaqta)2001Adults primed with Avaxim6463Active ControlActive control – same-disease vaccineNoVaqta 1 mL boosterReview CompleteADImmunogenicityAnti-HAV seroprotection 1 mo post-booster100% seroprotection both boosters; GMT higher with Avaxim (approximately 20 000 vs approximately 10 000 mIU/mL).Mild injection-site pain; no SAEs.11483268PubMed
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RCT303Hepatitis A Havrix+Vaqta booster combo2001Adults, ≥18356181Active ControlActive control – same-disease vaccineNoParticipants who received a second dose of Havrix as booster after initial Havrix (placebo group) instead of Vaqta booster (vaccine group)Review CompleteADSafety & ImmunogenicityCompare booster immunogenicity (BRR and GMT) of Vaqta vs. Havrix booster after initial Havrix doseVaqta booster was non-inferior to Havrix booster: booster response rate (BRR) was 86% (Vaqta) vs 80% (Havrix); geometric mean titers (GMT) 4,229 vs 3,053 mIU/mL; both were well tolerated.No serious vaccine-related AEs; fewer injection-site reactions in Vaqta group than Havrix (37% vs 60%)11170947PubMed
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RCT304Hepatitis A inactivated (concomitant)2002Adults 18–45 y (travellers)80160Active ControlActive control – same-disease vaccineNoHep-A vaccine aloneReview CompleteADImmunogenicitySeroprotection >=20 mIU/mL at 1 mo100% seroprotection whether given alone or with YF + Typhoid; non-inferior.Mild local pain; no vaccine-related SAEs.12044272PubMed
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RCT305Hepatitis B2006Adults with HIV 3942Active ControlActive control – same-disease vaccineNo2 doses of recombinant HBV vaccine 10 vs. 40 microgReview CompleteADImmunogenicityAntibody titers of >9.9 IU/LAn increase in dose of HBV vaccine did not show increase in the rate of response in HIV infected subjects. The only significant findings associated to the response rate was that a CD4 count > or = 200 cel/mm3Well tolerated, no serious adverse events were registered16600028PubMedRCT comparing two different doses (10 vs 40 micrograms) of the same recombinant hepatitis B vaccine in HIV-infected adults. Although both arms receive antigen, the standard dose group serves as an active comparator, so the study meets our criteria for controlled trials (active same-antigen, dose-comparison).
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RCT311Hepatitis B 1985Adults 17-19 y 110100Active ControlActive control – same-disease vaccineNoPlasma derived HBV vaccineReview CompleteADImmunogenicitySeroconversionSeroconversion (>2.1 UI/L) 100% vs 98-100%Plasma derived vaccine Mild adverse events were reported but no significant systemic effects (24.6% vs 22.4%). 4045435PubMed
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RCT315Hepatitis B - intradermal low-dose (HCWs)2002Health-care workers 18–55 y4848Active ControlActive control – same-disease vaccineNoStandard 20 µg IM HepBReview CompleteADImmunogenicityAnti-HBs >=10 mIU/mL at 6 moIntradermal 2 µg × 4 achieved 88% seroprotection vs 98% standard IM; GMT lower but acceptable.Mild local erythema; no vaccine-related SAEs.12693152PubMedRCT comparing the standard 20 microgram IM hepatitis B dose with a 2-microgram SQ dose in health-care workers. Although both arms receive the same antigen, the IM group functions as an active comparator, giving controlled immunogenicity and safety data relevant to dose-sparing.
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RCT318Hepatitis B (2 ug Intramuscular) 1989Adults, mean age 23.2 y 8382Active ControlActive control – same-disease vaccineNoHepatitis B (2 ug intradermal) Review CompleteADImmunogenicitySeroresponse Seroresponse was observed in 90% vs 94%Not reported2522147PubMed
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RCT319Hepatitis B (20 mcg/dose)1985Adults on chronic hemodialysis Mean age 52-54 y 1113Active ControlActive control – same-disease vaccineNoHBV vaccine 40 mcgReview CompleteADImmunogenicitySeroconversionNo subjects developed clinical hepatitis. No difference in seroconversion rate was observed between patients on hemodialysis.Not reported3898825PubMed
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RCT320Hepatitis B (3AV)2021Adults 18–45 y (Russia) (Phase 3 HepB 3-antigen vs single-antigen)5050Active ControlActive control – same-disease vaccineNo1AVReview CompleteADSafety & ImmunogenicitySeroconversion rate (anti-HBs ≥2.1 mIU/mL) at day 2103AV non-inferior to 1AV (100% vs 97.9% seroconversion), with higher antibody titers after 2nd and 3rd doses.No SAEs; mild local/systemic AEs comparable between groups.33119068PubMed10.1093/cid/ciaa1649. Randomized to a 3-dose series of 3-antigen (S/pre-S1/pre-S2) hepatitis B (HepB) vaccine (3AV), or to a single antigen vaccine (1AV).
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RCT321Hepatitis B (ayw)1982Adults (Air Force Cadets) 5554Active ControlActive control – same-disease vaccineNoHepatitis B vaccine (adw) Review CompleteADSafety & ImmunogenicitySurveillances of adverse events and seroresponse. Mild side effects were present in 27.4% vs 23.6 (non statistically significant) Seroresponse was observed in 81.5% vs 43.6%7047681PubMed
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RCT322Hepatitis B (DNA recombinant) 1988Adults (men) 8177Active ControlActive control – same-disease vaccineNoPlasma derived Hepatitis B vaccine Review CompleteADImmunogenicitySeroconversion Seroconversion was obserd in 74% vs 88% Not reported2973531PubMed
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RCT323Hepatitis B (Engerix B 20 ug) 1993Adults 39-70 y 198198Active ControlActive control – same-disease vaccineNoRecombivax HB 10 ug Review CompleteADImmunogenicitySeroconversionSeroconversion was similar at 8 months between groups 97% vs 95% Adverse events were present in 13.5% vs 15.9%8259774PubMed
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RCT291Hepatitis B (Engerix-B 20 ug) 1997Subjects that consumed 60 g of ethanol/day for at least 1 year5248Active ControlActive control – same-disease vaccineNoEngerix B 0,1,2, and 6 m 40 ug Review CompleteADImmunogenicitySeroconversion (≥10mUI/ml) Seroconversion was present in 75% vs 46%. No major side effects were determined to be caused by the vaccine.9316554PubMed
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RCT324Hepatitis B (HB-VAX 10 mcg) 1986Adults ≥18 y 297308Active ControlActive control – same-disease vaccineNoHepatitis B vaccine 20 mcg/dose Review CompleteADEfficacy & ImmunogenicityHBV events 1 HBV infection was reported in the intervention group and 0 in control group. Seroresponse at 8 months was 93.6% vs 96.1% (non statistically different). There were 5 adverse events in the intervention group and 11 in the controls; none of them lasting more than 36 h.2942599PubMed
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RCT325Hepatitis B (Hepacare)2001>18yo and not responded to HBV vaccination 460465Active ControlActive control – same-disease vaccineNoEngerix-BReview CompleteADSafety & ImmunogenicityResponse to vaccine via titersHepacare had 79% response rate and Engrix-B had 69.9%More hepacare reported pain at injection site than engrix group (63% vs 42%). no other sig differences between groups 11584378PubMed
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RCT326Hepatitis B (Hepatvax B) 1990Volunteers (medical students and employees or the Army Medical Collage) 51102Active ControlActive control – same-disease vaccineNoRecombivax HB Review CompleteADSafety & ImmunogenicityImmune response (anti HBsAg)Seroresponse was 94% and 90% for 10 ug recombinant and 2 ug plasma derived groups; while, it was 78% for 1 ug recombinant group.No severe adverse events were reported. 2144866PubMed
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RCT327Hepatitis B (Hepavax-Gene TF vs. Engerix-B)2017Neonates (China)959779Active ControlActive control – same-disease vaccineNoEngerix-BReview CompleteADEfficacy & ImmunogenicityMother-to-child HBV transmission>95% prevention of vertical transmission; noninferior to Engerix-B. Seroprotection rates also non-inferior, over 91% at 12 months in both groups.Comparable AE rates; mild local/systemic events. 67 SAEs total (4% vs. 3.7%), and 4 deaths (3 vs. 1), none were considered vaccine-related.27753794PubMed10.1097/INF.0000000000001361
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RCT328Hepatitis B (HEVAC B) 1988High risk population 1-57 y274317Active ControlActive control – same-disease vaccineNoHepatitis B vaccine (GCC VAC) Review CompleteADEfficacy & SafetyHepatitis events. Surveillances of adverse events. Hepatitis events were reported in 3.3% vs 5.4%. Seroresponse was observed in 87.2% vs 83.7%. Side effects were reported in 1.6% vs 1.5%. 2535239PubMed
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RCT329Hepatitis B (mpHBV) 2011Adults ≥50y 185355Active ControlActive control – same-disease vaccineNoEngerix and RecombivaxReview CompleteADSafety & ImmunogenicitySeroresponse (anti-HBs) Seroresponse was achieved in 75% of the study group and 68.0% and 77.4% for both of the controls. Seroresponse was lower with increasing age. No severe adverse events were vaccine related.22185811PubMed
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RCT330Hepatitis B (plasma derived 0.1 ug) 1984Adults 16-70 y 41952Active ControlActive control – same-disease vaccineNoHepatitis B vaccine (Dose 0.25 ug-3ug)Review CompleteADImmunogenicitySeroresponse. Seroresponse was observed in up to 90% in higher dose vs 88% in lower dose. No diference in reported side effects were observed between groups.6496450PubMed
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RCT332Hepatitis B (recombinant Vs plasma derived)1989Adults38399Active ControlActive control – same-disease vaccineNoFour doses of recombinant Vs fixed plasma derived doseReview CompleteADSafety & ImmunogenicityAdverse reactions. Antibody responseBoth vaccines elicited levels of antibodies to HBsAg in greater than 90% of the participants. Geometric mean titers of antibodies to HBsAg induced by the 10- and 20-micrograms doses of the rHBV vaccine did not differ from that induced by the plasma-derived vaccine and were higher than those induced by the 2- and 5-micrograms rHBV vaccine doses.Local and general side effects were mild and transient. No transaminase level elevation and autoantibody production were observed. 2527274PubMedRegamey, R. H, International Association of Biological Standardization., and International Symposium on Vaccination of Man and Animals by the Non-Parenteral Route. “Vaccinations in the Developing Countries : Proceedings of a Symposium Organized by the International Association of Biological Standardization and Held at the Hötel Novotel, Le Gosier, Guadeloupe, 16-20 April 1978.” Basel; New York: Karger, 1978. Print.
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RCT333Hepatitis B (Recombinant; 60 ug) 2021PLWHIV 9191Active ControlActive control – same-disease vaccineNoSame vaccine, 20 ug/doseReview CompleteADSafety & ImmunogenicityImmune response (anti-HBs) Immune response was higher in high dose group, however at month 7, difference was lost. No significant differences in reported adverse events 34052065PubMed
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RCT334Hepatitis B (Recombinant) 1990University staff and students with negative HBV markers557188Active ControlActive control – same-disease vaccineNoHepatitis B vaccine (plasma derived)Review CompleteADImmunogenicitySeroconversionSeroconversion was observed in 94.4% and 97.3%Not reported2141247PubMed
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RCT335Hepatitis B (recombinantIM20 vs IM60)2017HD pts age 18-70y (China)175174Active ControlActive control – same-disease vaccineNoStandard 20 microgram dosing of same vaccineReview CompleteADSafety & ImmunogenicityImmunologic responseThe vaccine-elicited antibody responses peaked at month 7, and declined at month 12. At month 7, the IM60 group had stronger GMC of anti-HBs, and a higher proportion of seroconversion and high-level response than the IM20 group did (P < 0.05).All the reported adverse reactions were mild and no SAEs were noted28803502PubMed
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RCT336Hepatitis B (S, preS1 and preS2)1997Adults 20-26 y 5050Active ControlActive control – same-disease vaccineNoEngerix B vaccineReview CompleteADImmunogenicityEnhace of anti HBs seroresponse Not improved in vivo responseNot reported9364674PubMed
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RCT337Hepatitis B (S, PreS1 and PreS2) 1997Adults with history of poor response to HBV vaccination1418Active ControlActive control – same-disease vaccineNoEngerix B vaccineReview CompleteAdImmunogenicitySeroresponseSeroresponse was present in 93% and 89%Not reported9364675PubMed
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RCT338Hepatitis B (Subcutaneously) 1988Hospital workers148153Active ControlActive control – same-disease vaccineNoIntramuscular Hepatitis B vaccine Review CompleteADImmunogenicitySeroresponse (anti HBsAb)Seroresponse was 90.8-92.9% in subcutaneous groups and 83.1-95.4% in the intramuscular groups at 180 days. No severe adverse events were reported; mild side effects were present in 3.9% vs 6.4%2969825PubMed
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RCT339Hepatitis B (Triantigenic) 2021Adults ≥18 y 796811Active ControlActive control – same-disease vaccineNoMonoantigenic HBV vaccine Review CompleteADSafety & ImmunogenicityNon inferiority in seroprotection Non inferiority criteria was met. In full analysis; superiority criteria was met favouring study group. Systemic adverse events were present in same frequency in both groups. 33989539PubMed
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RCT340Hepatitis B (Triple S recombinant)1997Adults 18-70 y 7525Active ControlActive control – same-disease vaccineNoTriple S recombinant 5 ug Review CompleteADImmunogenicitySeroconversionSeroconversion was present 60-80% Not reported9040320PubMed
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RCT341Hepatitis B (yeast-derived) 1988Medical students 17446Active ControlActive control – same-disease vaccineNoHepatitis B vaccine (plasma-derived) Review CompleteADSafety & ImmunogenicitySurveillances of adverse events and seroresponse. Seroresponse was 100% among groups.No differences in reported side effects frequency; general symptoms were present in 15% of subjects. 2975448PubMed
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RCT343Hepatitis B recombinant (Hansenula polymorpha) vaccine with CpG ODN adjuvant2020Healthy adults aged 18-60 years2424Active ControlActive control – same-disease vaccineNoCommercially available Hepatitis B vaccineReview CompleteADSafety & ImmunogenicityTo evaluate the safety and immunogenicity (specifically the effect of the CpG ODN adjuvant) of the experimental hepatitis B vaccine compared to a commercial vaccine.The CpG-adjuvanted hepatitis B vaccine demonstrated superior immunogenicity. After the full three-dose course, the geometric mean concentration (GMC) of antibodies in the experimental group was significantly higher than in the control group (2598.56 mIU/ml vs. 371.97 mIU/ml). The rate of participants achieving a "strongly positive" antibody response was also significantly higher in the experimental group (79.17% vs. 33.33%).The CpG-adjuvanted vaccine was safe and well-tolerated. The overall incidence of adverse events was not significantly different between the experimental group (66.67%) and the control group (54.17%). All reported adverse events were mild or moderate (grade 1 or 2) in severity.32842315PubMed
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RCT345Hepatitis B virus (recombinant HBsAg; GeneVac-B vs Engerix-B)2007Healthy neonates 0 – 2 weeks (Pune, India)132130Active ControlActive control – same-disease vaccineNoEngerix-B (10 µg recombinant HBsAg, yeast-derived)Review CompleteADSafety & ImmunogenicityAnti-HBs seroprotection (>=10 mIU ml to the minus 1) 1 mo after dose 3Seroprotection 97% (GeneVac) vs 95% (Engerix); GMT 383 vs 285 mIU ml to the minus 1; differences not significant.Mild fever =<6% per dose; no vaccine-related serious AEs; overall reactogenicity comparable.17478542PubMed
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RCT346Hepatitis B, multiple recombinant vaccines2011Adults, 18-45 y (Cuba)4000 (see note)Active ControlActive control – same-disease vaccineNoDiffering formulations (see note)Review CompleteADSafety & ImmunogenicitySeroprotection rate 1 month after dose 3Seroprotection ranged from 89.5% to 100%.Well tolerated, no serious AEs; pain most common AE; no vaccine-related withdrawals21941089PubMedRanomdized to one of 4 vaccines: vaccines included in this study were Heberbiovac-HB® (Heber Biotec S.A., Havana, Cuba), Euvax-B®(LG Chemical Ltd., Seoul, Korea), Hepavax-Gene® (Greencross Vaccine Corp., Seoul, Korea) and Engerix-B® (GlaxoSmithKline Biologicals, Rixensart, Belgium).
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RCT355Herpes simplex (gD2-AS04)2013Adults, 18–42 y1500 (see note)Active ControlActive control – same-disease vaccineNoDifferent formulations/combinations (see note)Review CompleteADSafety & ImmunogenicitySeropositivity, anti-gD antibodies, HSV neutralizing antibodiesAll vaccine groups were comparable in terms of seropositivity rates (100%) and GMTs at all time points. At least 65% neutralizing antibodies in each group.Mild to moderate local/systemic AEs; no vaccine-related SAEs. 9 SAEs total.23434737PubMed10.4161/hv.24043. Randomized to one of five different vaccine formulations: 3 different antigen doses [20, 40 or 80 μg of truncated glycoprotein D from HSV-2 strain (gD-2t)], different aluminum salts [AlPO4 or Al(OH)3], different preservatives or different volumes of vaccine (0.5 or 1 ml).