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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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RCT001Acute respiratory infection 9-strain polyvalent virus vaccine: 4 x influenza (A, A1, A2/Asian 200 C.C.A., B/Great Lakes), 3 x adenovirus (types 3, 4, 7), 2 x parainfluenza (types 1, 3)1964Healthy infants & children, 7 mo – 15 y (community clinics + training-school, Saskatchewan)258258PlaceboPlacebo - adjuvantNoSaline + formalin + Alum phosphate placeboReview CompleteADEfficacyClinically recorded respiratory illness over 1 y (all URTI, croup, bronchitis, pneumonia, influenza)235 illnesses/258 vaccinees vs 184/258 placebo; x2 = 5.78, P < 0.02; no protection; trend to more URTI & croup in vaccineesMild local erythema (8–25 mm) in 16%; systemic reactions negligible; no sequelae reported14105010PubMedLaxdal OE, et al. Acute respiratory infections in ihildren (part II, a trial of polyvalent virus vaccine). CMAJ 1964;90:15-19. Double-blind, two doses 14 d apart; antibody rise durable only for influenza A2 (Asian); adenovirus & parainfluenza responses transient
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RCT002Adenovirus (ADV-4, 7)2013U.S. military recruits - adults3,0311,009PlaceboPlacebo - inertYesPlacebo InertLactose tabletsReview CompleteZNEfficacy & ImmunogenicityPrevention of febrile acute respiratory disease due to ADV-4 and seroconversion of neutralizing serum antibodies to ADV-7VE (ADV-4 acute respiratory disease): 99.3%. 1/3031 in the vaccine group vs. 48/1009 in ths control group. Seroconversion at 4 weeks: ADV-4 (94.5%); ADV-7 (93.8%)No significant difference in major adverse events. Higher in vaccine group: rhinorrhoea (0.003), procedural pain (0.038); Higher in Placebo group: back pain (0.008), arthropod bite (0.014), chills (0.0001), lymphadenopathy (0.02).23623865PubMedGiven concurrently with other routine vaccines. Additional long term safety Pubmed: 27475474
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RCT003Adenovirus (ADV-4,7,21)1979Men ≥17y (USA)367101PlaceboPlacebo - inertYesInert tabletsReview CompleteADPlacebo added and definedImmunogenicitySeroconversion in subjects lacking preexisting antibodies. Seroconversion in vaccine groups was 58-79%; pure placebo group was not assessed in this outcome. No clinical ADV infection were seen, however 2 volunteers in pure placebo group who were hospitalized developed a fourfold rise in antibody titer during convalescent phaseNot reported458200PubMed
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RCT004Adenovirus (ADV21)1972US army volunteers3512PlaceboPlacebo - inertYesEnteric-coated capsule with inert ingredients (principally microcrystalline cellulose and lactose)Review CompleteJSchanged from excipient to inertSafety & ImmunogenicitySeroconversion and safetySerconversion was seen in 17-80% of vaccine groups, and 0% in placebo group.Mild symptoms were reported in 3 subjects of vaccine group.4564559PubMed
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RCT005Adenovirus types 4 & 7 (oral)2008Healthy adults 17–41 y (military)3028PlaceboPlacebo - inertYesStarch placeboReview CompleteZNSafety & ImmunogenicityFebrile acute respiratory disease (ARD) due to Ad 4/7 <= 21 dVE 99% vs Ad 4, 96% vs Ad 7; no vaccine-related SAEs.Transient mild GI symptoms; no serious AEs.18448211PubMed
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RCT006Andes virus - Hantavirus pulmonary syndrome (ANDV DNA) 2024Healthy adults 408PlaceboPlacebo - inertYesSaline solutionReview CompleteZNSafety & ImmunogenicityImmune response and surveillance of adverse events Seroconversion was observed in ≥80% of vaccinees. No severe adverse events were reported. 37380156PubMed
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RCT007Anthrax1962US adults- mill workers with no prior history of anthrax379414PlaceboPlacebo - adjuvantNoPlacebo Adjuvant0.1% alumReview CompleteADEfficacyIncidence of anthrax infection (cutaneous and inhalational)VE (all types of anthrax): 92.5% by expected cases analysis of enrollees with complete series. VE 80.7% by cases in each group. 3/379 (0.8%) in the vaccine group vs. 17/414 (4.1%) among controls. Up to 40% of vaccinated patients had 3 or 4+ local reactions, including edema. These resulted in a total of 6 days of work lost. Systemic reactions (malaise) occured in 2 vaccinated patients. Only 3 control patinets had mild, local reactions. 1 control patient died of anthrax.18017912PubMed"The employees who had not had anthrax were divided into two numerically equal groups according to their length of employment, age, the department in which they were employed, and the specific job performed."
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RCT008Anthrax2013Adults1,303260PlaceboPlacebo - inertYesPlacebo InertSaline solution Review CompleteZNImmunogenicityAnti-PA IgG GMC / GMT, % >= 4-fold riseVE 99.3-100% vs. 0% response in the control groupSolicited local & systemic AEs; SAEs. 231 serious AEs, including 7 deaths, occurred following 11,135 injections. These serious AEs occurred in 186 (11.9%) of the 1563 participants and were distributed across all 6 study groups.24373307PubMed
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RCT009Anthrax2013Adult 18-50 yrs9015PlaceboPlacebo - inertYesPlacebo InertSaline solution Review CompleteZNImmunogenicityThe primary assay endpoint was the 50% neutralization factor (TNA NF50). GMT of Toxin neutralizing antibody were 3-4 fold higher at 5 weeks No autoimmune events were noted23701746PubMed
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RCT010Anthrax (BioThrax ± CpG adjuvant)2011Adults 18-45 y4623PlaceboPlacebo - adjuvantNoCPG 7909 adjuvant alone.Review CompleteADchanged comparator safety inert to NoSafety & ImmunogenicityImmune response and surveillance of adverse events. Immune response was higher in the vaccine + adjuvant groupGrade 3 adverse events were more frequent in the BioThrax + adjuvant group; no grade 4 o 5 adverse events ocurred.21624418PubMed
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RCT011Anthrax (Px563L, a recombinant vaccine)2021healthy male and female subjects who were 18–55 y486PlaceboPlacebo - inertYesSaline solution Review CompleteZNSafety & Immunogenicitysafety (AEs) and immunogenicity (neutralizing antibody) analysis was conducted after all subjects completed the Day 70 visitor the primary immunogenicity endpoint (protective toxin neutralizing antibody 50% neutralization factor [TNA NF50]), titers started to increase significantly after the second administration of Px563L, from Day 35 through Day 70, with the geometric mean and lower bound of the 95% confidence interval exceeding 0.56, a threshold correlating with significant survival in animal models of anthrax exposure.
In conclusion, Px563L, administered as two IM doses 28 days apart, was well-tolerated and elicited a protective antibody response starting at seven days after the second vaccination. These findings support the continued development of Px563L in a two-dose regimen for anthrax post-exposure prophylaxis.		Vaccinations with Px563L at all dose levels were well-tolerated. There were no serious adverse events or adverse events (AE) leading to early withdrawal. In all treatment groups, most AEs were due to injection site reactions, and all AEs at the 10 and 50 mcg dose levels were mild.34544599PubMed
Px563L is a next-generation anthrax vaccine candidate consisting of a protein subunit, mutant recombinant protective antigen SNKE167-ΔFF-315-E308D (mrPA), and liposome-embedded monophosphoryl lipid A (MPLA) adjuvant. Three dose levels of Px563L (10, 50, and 80 mcg mrPA) were investigated
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RCT012Anthrax rPA102 (ascending doses)2006Healthy adults 18–55 y7324PlaceboPlacebo - inertYesSaline solution Review CompleteZNSafety & ImmunogenicityAnti-PA IgG GMT 1 mo after Dose 2All three dose levels exceeded the protective threshold; clear dose–response.Local arm pain mild; no vaccine-related SAEs.16797805PubMed
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RCT013Anthrax, Vaccine Adsorbed (AVA), 5 treatment groups2008Adults, 18-61 y (USA)836169PlaceboPlacebo - inertYesSalineSaline solution Review CompleteZNSafety & ImmunogenicityProportion of responders with a 4-fold rise in titer at month 798.2-99.4% response in the vaccine groups vs. 0.6% in the placebo groupCompared between SQ and IM arms. In general, SQ resulted in more injection site reactions but similar systemic reactions. There were 51 SAEs and 3 deaths. 7 SAEs were possibly vaccine related and are detailed.18827210PubMeddoi:10.1001/jama.300.13.1532 Treatment groups differed in dose and route. These were also compared to each other. At month 7, all groups were noninferior to the licensed regimen for all endpoints.
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RCT014Bacillus anthracis (GC1109)2019adults 18-55y7715PlaceboPlacebo - inertYesSaline solution Review CompleteZNSafety & ImmunogenicityImmunologic responsen per-protocol analysis, TNA GMTs at week 12 were 296.5, 285.2, and 433.2 in the three groups, respectively. Seroconversion rates measured by ELISA were 100% at week 12 in the three groupsLocal and systemic vaccine-related adverse events were frequent; however, most of them were mild, and no serious events were observed31151800PubMed
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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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RCT016Bordetella pertussis (acellular vaccine) 1999Adults 18-45 y 45031PlaceboPlacebo - excipient onlyNoSaline solution with 0.01% thimerosal Review CompleteJS
Changed from "Placebo - adjuvant" to "Placebo - excipient only" and safety_inert to No; saline with 0.01% thimerosal is a preservative-containing excipient, not an inert buffer.
Safety & ImmunogenicitySeroconversion Immune response developed in all vaccinees groupsMinor local reactions were similar among groups. 10395855PubMed
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RCT017Bordetella pertussis (Bordetella pertussis vaccine)2001Healthy adults >18 w/ exposure to hospital outbreak10297Active ControlActive control – unrelated vaccineNoMeningococcal vaccine (menomune)​Safety & ImmunogenicitySerological status to pertussus and AEsAnti-pertussus toxoid IgG 2-fold increases in 85% of patients, 4-fold increases in 73% of patients. Anti filamentous hemmaglutinin increase 92% 2x and 63% for 4xNo severe AEs. Local reactions (pain or tenderness, redness, swelling, and induration) and systemic reactions (fever, sleepiness or lethargy, and irritability) similar between vax and control11528571PubMed
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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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RCT030Bordetella pertussis (DTaP/DTwP) 1996Children 6-28 w (Italy) 14,0461,555Active ControlActive control – unrelated vaccineNoDiphteria and Tetanus toxoid (DT) vaccine ​Efficacy & SafetyPertussis VE 84% for acellular vaccine. VE 36% for whole cell vaccine.DTwP had more adverse events that either other group. No episodes of anaphylaxis or encephalopathy were observed. All events lasted ≤48 h and recovered without sequelae8538704PubMed
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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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RCT032Bordetella pertussis (DTwP) 1995Children 4-5 y 9694Active ControlActive control – unrelated vaccineNoDiphteria and Tetanus toxoid​Safety & ImmunogenicityImmune response against pertussis componentsAntibody response against pertussis components were higher in th DTP group Local adverse events were more frequent in DTP vaccinees 8578802PubMed
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RCT033Bordetella pertussis (Intranasal BPZE1 - Live attenuated) 2023Adults 18-50 y 23050PlaceboPlacebo - inertYesActive control: TDaP vaccine. Placebo control: Saline injection or intranasal lyophilised placebo bufferReview CompleteJS
Changed control_type from Active control to Placebo and comparator type from "Active control - vaccine for same disease" to "Placebo - inert"; trial includes a saline/lyophilised placebo arm, and per our rule we classify by the presence of an inert placebo comparator.
Safety & ImmunogenicityIgA immune response and surveillance of adverse events Higher B. pertussis specific mucosal secretory IgA response was observed in study group. No severe vaccine related adverse events were reported36906345PubMed
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RCT034Bordetella pertussis (LPF-Toxoid vaccine)1988Children 5-11 m2,847954PlaceboPlacebo - excipient onlyNoVaccine solvent containing formaldehyde, thiomersal, and aluminum phosphate in a PBS base.Review CompleteJSEfficacy & SafetyCulture confirmed pertussis in 15 monthsVE was 54-69%Small local reactions were more frequent in vaccinees. 2896826PubMed
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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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RCT029Bordetella pertussis (Tdap) 2020Pregnant women at 27-36 weeks of gestation341346PlaceboPlacebo - inertYesSaline solutionReview CompleteZNSafety & ImmunogenicityPertussis antibodies in cord blood and surveillance of adverse events Pertussis immune response (maternally transferred pertussis antibodies) was demonstrated. No severe adverse events were reported (vaccine-related) 31776029PubMed
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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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RCT038Borrelia burgdorferi - Lyme disease (VLA15), 5 treatment groups2024Adults, 18–65 y646175PlaceboPlacebo - inertYesPhosphate-buffered salineReview CompleteZNSafety & ImmunogenicityOspA-specific IgG geometric mean titres (GMTs) 1 month post-3rd doseVLA15 (especially 180 µg) induced robust antibody responses across all OspA serotypes, with the 0-2-6 month schedule showing higher and longer-lasting GMTsMild to moderate local and systemic adverse events were common but well tolerated; no vaccine-related serious adverse events. There were 24 SAEs in total.38830375PubMed10.1016/S1473-3099(24)00175-0. A summary of two phase 2 studies. Study 1: 29 (90 µg), 215 (135 µg), 205 (180 µg); Study 2: 97 (135 µg), 100 (180 µg).
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RCT039Borrelia burgdorferi (OspA vaccine)1998Adults ≥18 y817817PlaceboPlacebo - inertYesSaline solution Review CompleteZNEfficacyPossible Lyme disease (Antibody based) VE 37-40%Not reported9717677PubMed
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RCT040Borrelia spp. OspA-based vaccine (VLA15 booster)2024Healthy adults 18–65 years of age3919PlaceboPlacebo - inertYesPhosphate-buffered salineReview CompleteAMSafety & ImmunogenicityTo evaluate the immunogenicity and safety of a VLA15 booster dose administered 12 months after a primary vaccination series.A booster dose induced strong anamnestic immune responses against all six vaccine serotypes, with antibody titers peaking at 1 month post-booster and remaining elevated at 12 months compared to placebo.The booster dose was safe, with a higher frequency of mild-to-moderate solicited local adverse events in the vaccine group compared to placebo. The frequency of systemic events was not significantly different.39029481PubMed
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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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RCT042Chikungunya (CHIKV VLP)2020Adults 18-60 y 201199PlaceboPlacebo - inertYesPhosphate buffered saline Review CompleteAMSafety & ImmunogenicitySurveillance of adverse events and immune reponse High immune response was elicited among vaccinees There were no adverse vaccine-related adverse events 32286643PubMed
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RCT043Chikungunya (IXCHIQ)2023>18 years3,0931,035PlaceboPlacebo - inertYesPlacebo InertPhosphate-Buffered SalineReview CompleteAMImmunogenicityProportion of baseline negative participants with a seroprotective chikungunya virus antibody levelSeroprotection 98.6% (18-64 yrs), 100% (> 65 y) vs 0% in placebo. Serum neutralizing Ab GMT > 40 fold higher at day 29.Serious adverse events were 1.5% in VLA1553 exposed group and 0.8% in placebo group37321235PubMed05/2025: The FDA and CDC have recommended a pause in the use of the IXCHIQ chikungunya vaccine for individuals aged 60 and older due to reports of serious adverse events- this pause is in place while the agencies investigate these events, including neurologic and cardiac occurrences. The EMA has also restricted the use of the vaccine for adults over 65 years of age.
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RCT044Chikungunya (mRNA-1388) 2023healthy adults 18 - 49 years4515PlaceboPlacebo - inertYesSaline solution Review CompleteAMSafety & ImmunogenicitySafety (unsolicited adverse events [AEs]), tolerability (local and systemic reactogenicity; solicited AEs), and immunogenicity (geometric mean titers [GMTs] of CHIKV neutralizing and binding antibodies)Dose-dependent increases in neutralizing antibody titers were observed. Persistent humoral responses were observed up to 1 year after vaccination and remained higher than placebomRNA-1388 demonstrated favorable safety and reactogenicity profiles at all dose levels.37210308PubMed
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RCT045Chikungunya (MV-CHIK)2019Adults 18-55 y22934PlaceboPlacebo - inertYesSaline solution Review CompleteAMSafety & ImmunogenicityImmunogenicity (neutralising antibiodies against chikungunya virus)Antibodies were detected in all MV-CHIK groups, ranging from 12.87 to 174.80. Seroconversion ranges from 50-95.9%.No statistically significant difference in adverse events between the groups. No serious adverse events reported. solicited adverse events reported in 73% MV-CHIK group and 71% in control group; unsolicited
adverse events in 51% participants assigned to MV-CHIK and 50% in the control group.		30409443PubMed
Had a MV-CHIK group and a measles prime + MV-CHIK group.
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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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RCT047Chikungunya (recombinant measles virus based)2015adults 18-45y (Vienna)366Active ControlActive control – unrelated vaccineNoPriorix​Safety & ImmunogenicityImmune responseThe candidate vaccine raised neutralising antibodies in all dose cohorts after one immunisation, with seroconversion rates of 44% (n=4) in the low-dose group, 92% (n=11) in the medium-dose group, and 90% (n=10) in the high-dose group. The immunogenicity of the candidate vaccine was not affected by pre-existing anti-measles immunity. The second vaccination resulted in a 100% seroconversion for all participants in the candidate vaccine groups. The candidate vaccine had an overall good safety profi le, and the rate of adverse events increased with vaccine dose and volume. No vaccination-related serious adverse events were recorded25739878PubMed
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RCT048Chikungunya (Vimkunya)202512-64 years2,790464PlaceboPlacebo - adjuvantNoPlacebo AdjuvantSame excipient composition without chikungunya virus virus-like particle or aluminium hydroxide componentsReview CompleteADImmunogenicitySerum neutralising antibody seroresponse rate, neutralising antibody GMT and GMT ratio at day 22.At day 22: Seroresponse 97.8% vs 1.2%. Serum neutralizing Ab GMT 1618 vs 7.9.Medically attended adverse events in vaccine group 0.5% and 0.4% in placebo group40158526PubMed
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RCT049Chikungunya (Vimkunya)2025> 65 years206207PlaceboPlacebo - adjuvantNoPlacebo AdjuvantSame excipient composition without chikungunya virus virus-like particle or aluminium hydroxide componentsReview CompleteADImmunogenicitySerum neutralising antibody seroresponse rate, neutralising antibody GMT and GMT ratio at day 22.At day 22: Seroresponse 87% vs 1%, Serum neutralizing Ab GMT 724Grade >=3 adverse events 2% in vaccine group vs 1% in placebo group40158524PubMed
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RCT050Chikungunya (Vimkunya) 2025Adults >65 years206207PlaceboPlacebo - excipient onlyNosame excipient composition as the vaccine, but without the VLP antigen or aluminum hydroxide adjuvantReview CompleteJSSafety & ImmunogenicityAny safety reactions. difference in chikungunya virus SNA seroresponse rate The coprimary endpoints of immunologic superiority of chikungunya virus SNA titres compared with placebo and geometric mean titre at day 22 were met.no notable differences in adverse event rates between groups, and most adverse events were grade 1 or 2 in severity and of short duration. No vaccine-related serious adverse events or deaths occurred.40158524PubMed
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RCT051Chikungunya (VLA1553) 2025Adolescents 12-18 y 502252PlaceboPlacebo - inertYesPhosphate buffered saline Review CompleteAMSafety & ImmunogenicitySeroconversionSeroconversion present in 98.8% of vaccinees4 severe adverse events were vaccine related, they resolved within 1 week. Overall, vaccinees had more adverse events. 39243794PubMed
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RCT052Chikungunya (VLA1553) 2023Adults ≥18 y 3,0931,035PlaceboPlacebo - inertYesPhosphate-Buffered Saline Review CompleteAMSafety & ImmunogenicitySeroconversion and surveillance of adverse events Seroconversion was 98.9% 2 adverse events were considered to be vaccine related (mild myalgia and one syndrome of inappropiate antidiuretic hormone secretion, both participants recovered fully 37321235PubMed
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RCT053Chikungunya TSI-GSD-218 live attenuated vaccine2000Healthy US adults, 18-40y5914PlaceboPlacebo - excipient onlyNoMRC-5 culture fluidReview CompleteAMSafety & Immunogenicityproportion of vaccinees developing neutralizing antibodies by day 28 and remaining seropositive at one year post-immunization98% seroconverted by day 28; 85% remained seropositive at one year; no placebo recipients seroconvertedMild adverse effects; 8% reported transient arthralgia; no severe adverse reactions noted11304054PubMed
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RCT054Chikyngunya (Vimkunya) 2025Subjects 12-64 y 2,790464PlaceboPlacebo - excipient onlyNosame excipient composition as the vaccine, but without the VLP antigen or aluminum hydroxide adjuvant.Review CompleteJSchanged to not inertSafety & ImmunogenicityImmune response (neutroalising antibodies) Seroresponse difference was 96.6% No severe adverse events were observed 40158526PubMed
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RCT055Chlamidia (CTH522 adjuvanted with CAF01 liposomes or aluminium hydroxide)2019Healthy women 19-45 years305PlaceboPlacebo - inertYesSaline solutionReview CompleteAMSafety & Immunogenicitysafety and humoral immunogenicity (anti-CTH522 IgG seroconversion). Tseroconversion 100%. CTH522:CAF01 showed accelerated seroconversion, increased IgG titres, an enhanced mucosal antibody profile, and a more consistent cell-mediated immune response profileNo related serious adverse reactions were reported, and the most frequent adverse events were mild local injection-site reactions, which were reported in all (15 [100%] of 15) participants in the two vaccine groups and in three (60%) of five participants in the placebo group (p=0·0526 for both comparisons).31416692PubMed
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RCT056Chlamydia trachomatis - Trachoma (Bivalent)1967Children 351150Active ControlActive control – unrelated vaccineNoAqueous diphteria tetanus vaccineReview CompleteADEfficacyTrachomaVE 50% and 73%Not reported4960885PubMed
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RCT057Chlamydia trachomatis - Trachoma (Monovalent/Bivalent)19672nd-3rd grade school children (Taiwan)650653PlaceboPlacebo - adjuvantNoOil adjuvantReview CompleteADchanged comparator safety inert to NoEfficacy & ImmunogenicityClinical diagnosis of trachomaVE 30%Pain at injection site and/or fever were similar as in placebo (1-4%)6067317PubMed
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RCT058Chlamydia trachomatis - trachoma (TW-3 strain)1967Children 1-6y (Taiwan)194193PlaceboPlacebo - adjuvantNoSaline/AlumnReview CompleteADEfficacyDiagnosis of active Trachoma or laboratory proof of infectionCases with positive laboratory diagnosis Vaccine group 19% vs 29% in placebo groupNot reported6025183PubMed
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RCT059Chlamydia trachomatis- trachoma (CHLM-02) 2024Adults 18-45 y 606PlaceboPlacebo - inertYesSaline solutionReview CompleteAMSafety & ImmunogenicitySurveillance of adverse events and immune response (Anti-CTH522 seroconversion) Seroconversion was 100% among vaccinees and 0% in placebo group 1 subject discontinued dosing because of self limiting adverse event; Overall 1% of adverse events were grade 3 38615673PubMed
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RCT060Cholera2013Non-pregnant individuals older than 1 year (Kolkata, India)1,7271,768Active ControlActive control – unrelated vaccineNoheat-killed Escherichia coli K12 placeboReview CompleteADEfficacy & SafetyPrevention of episodes of culture-confirmed Vibrio cholerae O1 diarrhoea severe enough for patients to seek treatment in a health-care facilityDuring 5 years of follow-up, a two dose regimen of the cholera vaccine reduced the incidence of clinically significant cholera by about two-thirds in the study
population of individuals vaccinated at the age of 1 year
or older		Not reported24140390PubMed
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RCT061Cholera2002Healthy adults 18–45 y3837PlaceboPlacebo - inertYesBuffer placebo​Efficacy & Safety>=3 L cholera diarrhoea after challenge8/38 vs 21/37 severe cases; VE approximately 61%.Mild, self-limited GI symptoms only.11895960PubMed
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RCT062Cholera2009Healthy adults 18–45 y186116PlaceboPlacebo - inertYesBuffer placebo​Safety & ImmunogenicityModerate/severe cholera (>=3 L)57% vibriocidal response vs 4% placebo; no vaccine-related SAEs.No serious AEs; 2 mild GI events.19523608PubMed
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RCT063Cholera2019Pregnant women (Bangladesh)231234PlaceboPlacebo - inertYesStarch/xanthan gum​SafetyPrimary endpoint was pregnancy loss (spontaneous miscarriage or stillbirth), and the secondary endpoints were preterm delivery and low birth weightOCV during pregnancy does not increase the risk of pregnancy loss, preterm delivery, or low birth weightOCV during pregnancy was not associated with adverse pregnancy outcomes31092224PubMed
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RCT064Cholera - oral bivalent phenol-killed whole-cell cholera vaccine1975Healthy adult men, 21–40 y, Calcutta (India)2525PlaceboPlacebo - inertYesNutrient broth, oral​Safety & ImmunogenicityProtective antibacterial activity in infant-mouse assay (intestinal secretions) at day 28Antibody-positive secretions rose from 3/20 at baseline to 9/21 at day 28 (x2, P < 0.05); mean infant-mouse protection increased to 68.7% vs 9.4% in placeboNo systemic reactions; oral groups reported no adverse events779998PubMed
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RCT065Cholera ( Live Oral Vaccine CVD 103-HgR (PXVX0200))2020Children Aged 2-5 Years in the United States14824PlaceboPlacebo - inertYesSaline solution ​Safety & ImmunogenicityImmunogenicity measured via serum vibriocidal antibody levels on days 1, 11, and 29; safety and reactogenicity.Vaccine was safe, immunogenic, and well tolerated. The day 11 SVA seroconversion rate in the IEP of cohort 3 was 98.1%, which was non-inferior to the 93.5% rate in the adult bridging population and was also greater than 70%.Acceptable safety profile; no major concerns reported; There was one serious adverse event (SAE), a hospitalization for an asthma exacerbation and pneumonia, in a placebo subject, and one “life-threatening” fever (> 40°C, per protocol definition) in a PXVX0200 subject, which were both considered not related to study product.33319739PubMed
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RCT066Cholera (Aluminium phosphate-adsorbed vaccine) 1980Children ≥1 y (Calcutta)101,096101,030Active ControlActive control – unrelated vaccineNoTetanus toxoid vaccineReview CompleteADEfficacy & SafetyLaboratory confirmed cholera VE under 5 years old was 78.7-100%; VE over 5 years old was 47.6-56.4%There were no difference in side effects due to vaccination between groups. 7028299PubMed
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RCT067Cholera (attenuated recombinant Vibrio cholerae O1 vaccine strain CVD 103-HgR)2019Children 6 - 17 y32153PlaceboPlacebo - inertYesSaline solution ​Safety & ImmunogenicitySafety reactions. Antibody response by serum vibriocidal antibody (SVA)The SVA seroconversion rates 10 days after immunization were 98.6% and 2.1% in vaccine and placebo recipients, respectively, and the vaccine seroconversion rate was non-inferior to the 93.5% rate seen in adults aged 18-45 years.Most reactogenicity was mild to moderate, and there were no vaccine-related serious AEs. 31769402PubMed
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RCT068Cholera (B subunit vaccine) 1995Individuals 1-64 y (Colombia)604709PlaceboPlacebo - inertYesKilled E. coli K 12 Review CompleteADSafety & ImmunogenicitySeroresponse and surveillance of adverse events. Vaccine had appriate IgA and IgG seroresponse in vaccine groupNo adverse events attributable to vaccine were observed. 8605522PubMed
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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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RCT070Cholera (BS-WC) 1992Subjects ≥2y 2,2231,062PlaceboPlacebo - inertYesKilled E. coli K-12 Review CompleteADEfficacyCholera disease VE 46-57%Not reported1402014PubMed
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RCT071Cholera (Cholera, El Tor, Oil-adjuvant)1965Any age included (Philippines)438,000146,000Active ControlActive control – unrelated vaccineNoMonovalent typhoid vaccineReview CompleteADEfficacyCholera disease (El Tor)VE 26-56%Vaccination reactions in vaccine groups were 0.8%, 1.7% and 96.1% (oil-adjuvant vaccine); and 1.4% in control group5294176PubMed
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RCT072Cholera (CVD 103 HgR) 1992Children 5-9 y 33298PlaceboPlacebo - inertYesInactivated E. coli K-12 Review CompleteADImmunogenicityVibriocidal antibody response Seroresponse was present in 75-87% in 5x10ˆ9 vaccine group No difference in adverse events 1355798PubMed
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RCT073Cholera (CVD 103-HgR travellers)2005Adult travellers to Asia/Africa6965PlaceboPlacebo - inertYesOral saline placeboReview CompleteADEfficacyIncidence of travellers’ diarrhoea <= 3 wkDiarrhoea in 52% vaccine vs 46% placebo; no significant protection.Mild GI symptoms only; no vaccine-related SAEs.15982790PubMed
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RCT074Cholera (CVD 103-HgR)2016Adults 18-45y 95102PlaceboPlacebo - inertYesSaline solution Review CompleteADEfficacy & SafetyModerate to severe diarrhea VE 79.5% No differences in reported systemic adverse events 27001804PubMed
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RCT075Cholera (CVD 103-HgR) 2014Healthy young adults 5511PlaceboPlacebo - inertYes2 g lactose Review CompleteADImmunogenicityImmune response Seroconversion was 89% vs 57% Not reported 24173028PubMed
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RCT076Cholera (CVD 103-HgR) 1989Adults 20-30 y 1212PlaceboPlacebo - inertYesBuffer and destiled water Review CompleteADSafety & ImmunogenicitySurveillance of adverse events and fourfold or greater elevation in antibody titers. Seroresponse was seen in 92% of vaccinees.No adverse events were reported. 2807523PubMed
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RCT077Cholera (CVD 103-HgR) 1992Adults 18-40 y 4942PlaceboPlacebo - inertYesHeat killed E. coli K-12 Review CompleteADEfficacy & SafetyDiarrhea and surveillance of adverse events No differeces were observed in diarrhea rate.No adverse events attributable to vaccination were noted. 1398956PubMed
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RCT078Cholera (El Tor Ogawa)1973Any age82,22040,620Active ControlActive control – unrelated vaccineNoMonovalent typhoid vaccineReview CompleteADEfficacy & SafetyEfficacy of intradermal and SC routes (Incidence rate), safety profileID 11/10000 SC 6/10000, control 23/10000No SAEs related to intervention4603994PubMed
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RCT079Cholera (El Tor)1968Any age included (Philippines)268,70090,900Active ControlActive control – unrelated vaccineNoMonovalent typhoid vaccineReview CompleteADEfficacyCholera disease (El Tor)VE 53-58%. Incidence rate was 45.5/100,000 in control group; and incidence rate in vaccine groups were 18.8-21.3No difference was observed in reaction to vaccination among the 4 vaccine groups. No severe adverse events were observed.5303665PubMed
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RCT080Cholera (Four vaccines: Two classical, Ogawa and Inaba vaccines)1973Any age179,40044,200Active ControlActive control – unrelated vaccineNoMonovalent typhoid vaccineReview CompleteADEfficacyIncident casesallfour types of vaccine tested offered significant degrees ofprotection varying from 58 % to 71 %. The Ogawa vaccines were slightly, though not significantly, more protective than the Inaba vaccines against disease caused by Ogawa.Not reported4596491PubMed
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RCT081Cholera (live 638)2009Adults 18–40 y (Cuba)2412PlaceboPlacebo - inertYesSaline solution Review CompleteADSafety & ImmunogenicityVibriocidal seroconversion100% vs 0% placebo; vaccine highly immunogenic.No serious AEs; only mild GI symptoms.19720365PubMed
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RCT082Cholera (live oral vaccine CVD 103-HgR)2023children in the United States, 2-17y40167PlaceboPlacebo - inertYesSaline solution Review CompleteADImmunogenicitySeroconversion (Serum vibriocidal antibody (SVA))In the subset of subjects who consumed < 80 % of the vaccine dose, seroconversion rates were calculated and stratified by amount consumed. Of 468 subjects dosed, a subset of 33 (7 %) received < 80 % of the vaccine dose. SVA seroconversion occurred in 75.8 % of these subjects, including 100 % (7/7) of those who took 50–80 % and 69.2 % (18/26) of those who took < 50 %, versus 98.5 % of those who consumed 80 % or more. Vaccination with PXVX0200 produced an immune response in most children who received partial dosing. Since SVA seroconversion is a strong correlate of protection, PXVX0200 may protect against cholera infection in children who ingest only part of the vaccine doseNot studied; but overall tolerated.36959054PubMed
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RCT083Cholera (Monovalent Ogawa and Inaba)1969Children 3m-14y (Pakistan)29,9399,923Active ControlActive control – unrelated vaccineNoTetanus and diphteria toxoidReview CompleteADEfficacy & ImmunogenicityAntibody titre and case rateCholera hospitalized rate per 10,000 was 7 and 11 in vaccine groups and 26.2 in all Td group. Vibricidal serum titres of ≥1:20 were 89.9 % and 94.9% in vaccine groups vs 63% in control groupNot reported5306539PubMed
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RCT084Cholera (MucoRice-CTB) 2022Adults 18-55 y93PlaceboPlacebo - inertYesPowdered commercial cornstachReview CompleteADSafety & ImmunogenicityImmune response and surveillance of adverse eventsImmune response was elicited among vaccinesThere were no vaccine related adverse events 35484039PubMed
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RCT085Cholera (Ogawa/Inaba)1970Children ≤14 y (Pakistan)34,34111,430Active ControlActive control – unrelated vaccineNoTetanus and Diphteria toxoid vaccineReview CompleteADEfficacy & ImmunogenicityCholera disease and reactogenicityCholera case rate (Inaba) was 1.7-27.8/10,000 for vaccine groups (Vaccine "F" was the worst with 27.8/10,000); placebo group had a 32.4/10,000 rateNot reported4912069PubMed
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RCT086Cholera (oral whole cell vaccine)2008Children and adults 1 - 40 years101100PlaceboOtherNoKilled oral E. coli K12Review CompleteADSafety & Immunogenicityproportion of subjects with adverse events during the duration of study participation. For immunogenicity: Proportion of subjects who had a ≥4-fold rise in serum vibriocidal antibody titers 14 days after the second dose of vaccine or placeboFollowing immunization, 53% of adult and 80% of children vaccinees showed a ≥4 fold rise in serum V. cholerae O1 vibriocidal antibody titers. A less pronounced response to V. cholerae O139 vibriocidal antibody titers post-immunization was noted among vaccinees.Adverse reactions were observed with similar frequency among vaccine and placebo recipients in both age groups. 18523643PubMed
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RCT087Cholera (Oral: B subunit and whole cell) 1986Children 2-15 y (Bangladesh) 42,27821,220PlaceboOtherNoInactivatedE. coli K12 (Oral) Review CompleteADEfficacyLaboratory confirmed cholera VE 85% No differences between groups in side efects2873397PubMed
90
RCT088Cholera (Peru-15 Choleragarde)2015HIV+ adults 18 - 45 years1616PlaceboPlacebo - inertYesBuffer solutionReview CompleteADSafety & ImmunogenicitySafety reactions, antibody responseAmong the 16 vaccinees,14 vaccinees (87.5%) had seroconversion compared to 1 of 16 placebo recipients (6.3%).No serious adverse events were reported during the follow-up period in either group.26241948PubMed
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RCT089Cholera (Peru-15 live oral)2005Healthy adults (Bangladesh)4030PlaceboPlacebo - inertYesbicarbonate–ascorbic acid bufferReview CompleteADSafety & Immunogenicity>=4-fold vibriocidal-antibody riseSeroconversion 80% vs 7% placebo; vaccine well tolerated.No vaccine-related SAEs; mild GI upset similar to placebo.16028125PubMed
92
RCT090Cholera (Peru-15 oral vaccine)2007Children 9 months - 5 years140100PlaceboPlacebo - inertYesBuffer solutionReview CompleteADSafety & ImmunogenicitySafety reactions. Immune responseVibriocidal antibody responses developed in 42/50 (84%) toddlers (2-5 years) and 35/50 (70%) of younger children (9-23 months) and overall 77/100 (77%) who received the high dose. LPS-IgA-antibody responses were seen in 60% of toddlers and 34% of infants; 40% responded with IgA antibodies to cholera toxin. Vaccination did not elicit adverse events and the strain was genetically stable. 16996172PubMed
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RCT091Cholera (Peru-15) 1997Adults 18-50 y 3218PlaceboPlacebo - inertYesSkim milk Review CompleteADSafety & ImmunogenicityVibriocidal antibodies and surveillance of adverse events. Serum vibriocidal responses were seen in 100% of vaccinees, and none in placebo group No severe adverse events were reported.9207368PubMed
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RCT092Cholera (Sanchol, killed bivalent (O1 and O139) whole-cell oral)2011Healthy participants over 1 year31,93234,968PlaceboOtherNoIdentical–appearing heat-killed Escherichia coli K12 cellsReview CompleteADEfficacyculture-proven Vibrio cholerae O1 diarrhea episodes severe enough to require treatment in a health care facility.VE 66%Not reported22028938PubMed
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RCT093Cholera (Sanchol, killed bivalent (O1 and O139) whole-cell oral)2011Healthy participants 0 - 45 years165165PlaceboPlacebo - inertYesSugar buffer solutionReview CompleteADSafety & ImmunogenicityAny safety concerns. Vibriocidal antibody responseVibriocidal antibody responses in adults were 60% against Vibrio cholerae O1 Inaba, 72% against V. cholerae O1 Ogawa and 21% against V. cholerae O139. In toddlers, responses were 84%, 75% and 64% and in younger children it was 74%, 78% and 54% against Inaba, Ogawa and O139 serotypes. The responses in all ages were higher in vaccinees compared to pre-immune titers or to responses in placebo recipientsNo SAEs related to intervention21907255PubMed
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RCT094Cholera (VA1.4)2014Men and women aged 18-60 years from Kolkata, India.4443PlaceboPlacebo - inertYesDiluent placeboReview CompleteADSafety & ImmunogenicitySafety and immunogenicity of a live oral recombinant cholera vaccine VA1.4Study demonstrates that VA 1.4 at a single dose of 1.9×109 is safe and immunogenic in adults from a cholera endemic regionVaccine did not elicit any diarrhea related adverse events. Other adverse events were rare, mild and similar in two groups24983989PubMed
97
RCT095Cholera (Walter Reed, El Tor)1967≥2 years (Calcutta)53,10526,552Active ControlActive control – unrelated vaccineNoTyphoid-paratyphoid A and B vaccineReview CompleteADEfficacyCholera diseaseVE 4-9%Moderate fever at 24 hours 0.3-1.2% in vaccines group vs 1.2% in placebo group; fever after 72 hours 0% in all groups5301381PubMed
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RCT096Cholera (whole cell, bivalent, killed)2015Children and adults (1 year and above)108108PlaceboPlacebo - inertYesSugar buffered solutionReview CompleteADSafety & ImmunogenicityAEs 3 days after dosing or SAEs within 14 days following either dose. Seroconversion as 4-fold or greater rise in titers of serum vibriocidal antibodies 14 days after second dose81% adults and 77% children demonstrating seroconversion 14 days after the second dose of vaccineNo significant differences in rates of adverse events were observed between the vaccine and placebo groups. No serious adverse events were reported during the trial.26078323PubMed
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RCT097Cholera (Whole cell, recombinant B subunit) 1994Men 16-45 y 781782PlaceboOtherNoHeat killed E. coli K12 Review CompleteADEfficacyCholera diseaseVE 86% Not reported 7967990PubMed
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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