{ "generated": "2026-10-09", "method": "#15 Meta-analysis of randomized-trial safety outcomes from ClinicalTrials.gov posted results.\n\nFor each licensed product (ingredients/vaccine_product_composition.json) search ClinicalTrials.gov\nAPI v2 for interventional studies with posted results; keep trials with at least one arm naming\nthe product (or a vaccine dose) and one placebo/saline/no-vaccine control arm. From the\nadverse-events module take, per arm, participants with any SERIOUS adverse event and deaths.\nPool log risk ratios with DerSimonian-Laird random effects (0.5 continuity correction for zero\ncells), report I^2 and every trial. Output data/science/vaccine_trial_meta.json.\nCaveats (printed on pages): SAE totals are sponsor-coded over each trial's own follow-up; trials\nof a product may cover different ages and schedules.\nArm rules v2 (v1 mixed open-label/crossover periods with blinded placebo arms and produced a spurious\nCOVID-19 RR of 1.51 with I^2 94%): blinded-period arms only; open-label, crossover, booster, extension\nand follow-up-period arms excluded; a control arm must be placebo/saline in every component; an active\narm may not include a co-administered active vaccine.\n", "results": { "mmr": { "trials": [ { "nct": "NCT04333732", "title": "CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION", "product_query": "M-M-R II", "active_arms": [ "M-M-R II \u00ae" ], "control_arms": [ "Placebo" ], "sae": [ 11, 1722, 5, 1689 ], "deaths": [ 0, 1722, 0, 1689 ], "timeframe": "150 days from the date of administration of the investigational medicinal product" } ], "sae_pooled": { "rr": 2.1578397212543554, "lo": 0.7513341966236369, "hi": 6.197338392885003, "k": 1, "i2": 0.0, "tau2": 0.0 }, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 1722, "n_control": 1689 }, "hepatitis-b": { "trials": [], "sae_pooled": null, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 0, "n_control": 0 }, "dtap": { "trials": [], "sae_pooled": null, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 0, "n_control": 0 }, "hpv": { "trials": [], "sae_pooled": null, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 0, "n_control": 0 }, "polio": { "trials": [], "sae_pooled": null, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 0, "n_control": 0 }, "influenza": { "trials": [ { "nct": "NCT00539981", "title": "Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok", "product_query": "Flublok", "active_arms": [ "FluBlok (Lots A, B, C)" ], "control_arms": [ "Placebo" ], "sae": [ 30, 2344, 34, 2304 ], "deaths": [ 1, 2344, 1, 2304 ], "timeframe": "Unsolicited non-serious AEs: Day 0 to Day 28 post vaccination, Solicited reactions: within 7 days post vaccination, SAE: through the end of influenza season (up to 6 months)" } ], "sae_pooled": { "rr": 0.867295723750251, "lo": 0.532615053580246, "hi": 1.4122805342792324, "k": 1, "i2": 0.0, "tau2": 0.0 }, "death_pooled": { "rr": 0.9829351535836178, "lo": 0.06151499900340365, "hi": 15.706112847323505, "k": 1, "i2": 0.0, "tau2": 0.0 }, "sae_by_product": {}, "n_vaccine": 2344, "n_control": 2304 }, "covid": { "trials": [ { "nct": "NCT04754594", "title": "To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older", "product_query": "BNT162b2", "active_arms": [ "Maternal Participants: BNT162b2 30 mcg (Blinded Phase)", "HIV Positive Maternal Participants: BNT162b2 30 mcg (Blinded Phase)" ], "control_arms": [ "Maternal Participants: Placebo (Blinded Phase)", "HIV Positive Maternal Participants: Placebo (Blinded Phase)" ], "sae": [ 23, 173, 27, 173 ], "deaths": [ 0, 173, 0, 173 ], "timeframe": "Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age" }, { "nct": "NCT04470427", "title": "A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19", "product_query": "mRNA-1273", "active_arms": [ "Part A (Blinded): mRNA-1273" ], "control_arms": [ "Part A (Blinded): Placebo" ], "sae": [ 292, 15184, 308, 15162 ], "deaths": [ 16, 15209, 18, 15206 ], "timeframe": "up to Day 759 (end of study)" }, { "nct": "NCT04796896", "title": "A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age", "product_query": "mRNA-1273", "active_arms": [ "Part 2 (6-11 Years): mRNA-1273 50 \u00b5g", "Part 2 (2-5 Years): mRNA-1273 25 \u00b5g", "Part 2 (6-23 Months): mRNA-1273 25 \u00b5g" ], "control_arms": [ "Part 2 (6-11 Years): Placebo", "Part 2 (2-5 Years): Placebo", "Part 2 (6-23 Months): Placebo" ], "sae": [ 99, 8032, 11, 2668 ], "deaths": [ 0, 8032, 0, 2668 ], "timeframe": "Up to 2 years" }, { "nct": "NCT04649151", "title": "A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19", "product_query": "mRNA-1273", "active_arms": [ "Part 1A: mRNA-1273 100 \u03bcg" ], "control_arms": [ "Part 1A: Placebo" ], "sae": [ 21, 2486, 4, 1240 ], "deaths": [ 0, 2486, 0, 1240 ], "timeframe": "Day 1 up to Day 751" }, { "nct": "NCT04405076", "title": "Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older", "product_query": "mRNA-1273", "active_arms": [ "Part A: 50 ug mRNA-1273", "Part A: 100 ug mRNA-1273" ], "control_arms": [ "Part A: Placebo" ], "sae": [ 7, 400, 0, 200 ], "deaths": [ 0, 400, 0, 200 ], "timeframe": "Up to Month 15" }, { "nct": "NCT04505722", "title": "A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants", "product_query": "Ad26.COV2.S", "active_arms": [ "Double-blind Phase: Ad26.COV2.S 5*10^10 vp" ], "control_arms": [ "Double-blind Phase: Placebo" ], "sae": [ 235, 21898, 358, 21890 ], "deaths": [ 36, 21898, 64, 21890 ], "timeframe": "DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination" }, { "nct": "NCT04614948", "title": "A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults", "product_query": "Ad26.COV2.S", "active_arms": [ "Double Blind Phase: Ad26.COV2.S", "Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S" ], "control_arms": [ "Double Blind Phase: Placebo", "Double Blind Phase: Non-FAS Post-Dose 1: Placebo" ], "sae": [ 104, 15708, 136, 15592 ], "deaths": [ 6, 15708, 13, 15592 ], "timeframe": "DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85)" }, { "nct": "NCT04436276", "title": "A Study of Ad26.COV2.S in Adults (COVID-19)", "product_query": "Ad26.COV2.S", "active_arms": [ "COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)", "COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10)", "COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)", "COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10)", "COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)", "COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10)", "COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)", "COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10)", "COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10)", "COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL", "COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10", "COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)", "COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10)", "COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)", "COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10)" ], "control_arms": [ "COHORT 1A: Placebo, Placebo", "COHORT 1B: Placebo, Placebo", "COHORT 2A: Placebo, B: Placebo", "COHORT 3: Placebo, Placebo" ], "sae": [ 14, 761, 4, 180 ], "deaths": [ 4, 761, 0, 180 ], "timeframe": "Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days" } ], "sae_pooled": { "rr": 1.015920504068854, "lo": 0.7526332505337231, "hi": 1.3713112858827503, "k": 8, "i2": 0.7949608300639429, "tau2": 0.10284363454642664 }, "death_pooled": { "rr": 0.6219532981401615, "lo": 0.4488887085383959, "hi": 0.8617412238479981, "k": 4, "i2": 0.0, "tau2": 0.0 }, "sae_by_product": { "BNT162b2": { "rr": 0.8518518518518517, "lo": 0.5091446383523042, "hi": 1.4252366083079762, "k": 1, "i2": 0.0, "tau2": 0.0 }, "mRNA-1273": { "rr": 2.0357365482892464, "lo": 0.8393790702056769, "hi": 4.937248784420055, "k": 4, "i2": 0.8251919982399981, "tau2": 0.5492870195534806 }, "Ad26.COV2.S": { "rr": 0.686732199496128, "lo": 0.5991321284800758, "hi": 0.7871404176257139, "k": 3, "i2": 0.0, "tau2": 0.0 } }, "n_vaccine": 64642, "n_control": 57105 }, "varicella": { "trials": [], "sae_pooled": null, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 0, "n_control": 0 }, "rotavirus": { "trials": [ { "nct": "NCT00090233", "title": "Rotavirus Efficacy and Safety Trial (REST)(V260-006)", "product_query": "RotaTeq", "active_arms": [ "RotaTeq\u2122" ], "control_arms": [ "Placebo" ], "sae": [ 863, 34904, 955, 34862 ], "deaths": null, "timeframe": "Participants in this study were followed for all serious adverse events (SAEs) and other adverse events (AEs), for up to 42 days following each study vaccination" }, { "nct": "NCT00362648", "title": "Developing World Study for RotaTeq\u2122 (V260-015)(COMPLETED)", "product_query": "RotaTeq", "active_arms": [ "RotaTeq\u2122", "RotaTeq\u2122, Placebo, RotaTeq\u2122", "Placebo, Placebo, RotaTeq\u2122", "RotaTeq\u2122 - Kenya Safety Cohort" ], "control_arms": [ "Placebo", "Placebo - Kenya Safety Cohort" ], "sae": [ 145, 3748, 156, 3745 ], "deaths": null, "timeframe": "Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination." }, { "nct": "NCT00092443", "title": "Dose Confirmation Efficacy Study (V260-007)", "product_query": "RotaTeq", "active_arms": [ "RotaTeq\u2122 at Expiry Potency (\u22481.1 x 10^7 IU/Dose)" ], "control_arms": [ "Placebo Matching RotaTeq\u2122" ], "sae": [ 21, 649, 28, 658 ], "deaths": null, "timeframe": null }, { "nct": "NCT00092456", "title": "Consistency Lots Vaccine Study (V260-009)", "product_query": "RotaTeq", "active_arms": [ "RotaTeq\u2122 Lot 1", "RotaTeq\u2122 Lot 2", "RotaTeq\u2122 Lot 3" ], "control_arms": [ "Placebo" ], "sae": [ 10, 679, 3, 111 ], "deaths": null, "timeframe": "Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first." }, { "nct": "NCT00718237", "title": "Phase III Placebo-controlled Study of V260 (RotaTeq\u2122) in Japanese Healthy Infants (V260-029)(COMPLETED)", "product_query": "RotaTeq", "active_arms": [ "RotaTeq\u2122" ], "control_arms": [ "Placebo" ], "sae": [ 7, 380, 9, 381 ], "deaths": null, "timeframe": "14-day period following each vaccination. Any death, Vaccine related SAE and Intussusception were collected during the study period." }, { "nct": "NCT00880698", "title": "Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers", "product_query": "RotaTeq", "active_arms": [ "HIV-1 Uninfected RotaTeq", "HIV-1 Infected RotaTeq" ], "control_arms": [ "HIV-1 Uninfected Placebo", "HIV-1 Infected Placebo" ], "sae": [ 7, 99, 8, 103 ], "deaths": null, "timeframe": "From study enrollment until study completion (up to 24 weeks)" }, { "nct": "NCT00329745", "title": "Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)", "product_query": "Rotarix", "active_arms": [ "Rotarix Group" ], "control_arms": [ "Placebo Group" ], "sae": [ 10, 4359, 11, 4328 ], "deaths": null, "timeframe": null }, { "nct": "NCT01171963", "title": "Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants", "product_query": "Rotarix", "active_arms": [ "Rotarix Group" ], "control_arms": [ "Placebo Group" ], "sae": [ 183, 1666, 246, 1667 ], "deaths": null, "timeframe": "Solicited symptoms were collected during the 8-day (Days 0-7) post vaccination period. Unsolicited AEs were collected during the 31 day (Days 0-30) post vaccination. SAEs were collected throughout the entire study period (Months 0 to 21)." }, { "nct": "NCT00241644", "title": "Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants", "product_query": "Rotarix", "active_arms": [ "Rotarix 2-dose Group", "Rotarix 3-dose Group", "Rotarix Pooled Group" ], "control_arms": [ "Placebo Group" ], "sae": [ 842, 6596, 246, 1641 ], "deaths": null, "timeframe": null }, { "nct": "NCT00420316", "title": "Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.", "product_query": "Rotarix", "active_arms": [ "Rotarix Group" ], "control_arms": [ "Placebo Group" ], "sae": [ 4, 1082, 7, 531 ], "deaths": null, "timeframe": "Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)" }, { "nct": "NCT00480324", "title": "Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants", "product_query": "Rotarix", "active_arms": [ "Rotarix Group" ], "control_arms": [ "Placebo Group" ], "sae": [ 72, 508, 44, 257 ], "deaths": null, "timeframe": null }, { "nct": "NCT00969228", "title": "Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix\u2122 Vaccine in Korean Infants", "product_query": "Rotarix", "active_arms": [ "Rotarix Group" ], "control_arms": [ "Placebo Group" ], "sae": [ 17, 508, 13, 176 ], "deaths": null, "timeframe": "Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)" }, { "nct": "NCT01616693", "title": "Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines", "product_query": "Rotarix", "active_arms": [ "Zinc and Probiotic", "Zinc Alone", "Probiotic Alone" ], "control_arms": [ "Placebo" ], "sae": [ 10, 463, 4, 155 ], "deaths": [ 0, 463, 0, 155 ], "timeframe": "from first day of study to 4 weeks after last dose (11 weeks)" } ], "sae_pooled": { "rr": 0.8575444449559637, "lo": 0.8049867907306663, "hi": 0.9135335927777692, "k": 13, "i2": 0.0, "tau2": 0.0 }, "death_pooled": null, "sae_by_product": { "RotaTeq": { "rr": 0.8999616332119509, "lo": 0.8288263865985991, "hi": 0.9772021672444314, "k": 6, "i2": 0.0, "tau2": 0.0 }, "Rotarix": { "rr": 0.7875716758531929, "lo": 0.6943533423930536, "hi": 0.8933047581631572, "k": 7, "i2": 0.13714030427462043, "tau2": 0.00417668490862738 } }, "n_vaccine": 55641, "n_control": 48615 }, "hib": { "trials": [], "sae_pooled": null, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 0, "n_control": 0 }, "pcv": { "trials": [], "sae_pooled": null, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 0, "n_control": 0 }, "meningococcal": { "trials": [], "sae_pooled": null, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 0, "n_control": 0 }, "hepatitis-a": { "trials": [ { "nct": "NCT00224484", "title": "Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old", "product_query": "Havrix", "active_arms": [ "Group Havrix", "Pooled Group" ], "control_arms": [ "Group Saline" ], "sae": [ 142, 4469, 37, 1487 ], "deaths": [ 0, 4469, 0, 1487 ], "timeframe": "Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination." } ], "sae_pooled": { "rr": 1.2769892291037963, "lo": 0.8936163595519095, "hi": 1.8248339724496525, "k": 1, "i2": 0.0, "tau2": 0.0 }, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 4469, "n_control": 1487 }, "shingles": { "trials": [ { "nct": "NCT03563183", "title": "A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022", "product_query": "HZ/su", "active_arms": [ "Non-Frail-HZ/su", "Pre-Frail-HZ/su", "Frail-HZ/su", "Unknown-HZ/su" ], "control_arms": [ "Non-Frail-Placebo", "Pre-Frail-Placebo", "Frail-Placebo", "Unknown-Placebo" ], "sae": [ 1734, 13487, 1817, 13489 ], "deaths": [ 599, 13487, 640, 13489 ], "timeframe": "Solicited symptoms: within 7 days (Days 0-6) after vaccination; Unsolicited adverse events: within 30 days (Days 0-29) after vaccination; Serious Adverse Events (SAEs): during the entire study period (3 to 5 year period following Day 0)." }, { "nct": "NCT04091451", "title": "Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster", "product_query": "HZ/su", "active_arms": [ "HZ/su Group" ], "control_arms": [ "Placebo Group" ], "sae": [ 56, 714, 43, 712 ], "deaths": [ 12, 714, 8, 712 ], "timeframe": "Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)." }, { "nct": "NCT05219253", "title": "A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India", "product_query": "HZ/su", "active_arms": [ "HZ/suSeq Group" ], "control_arms": [ "Placebo Group" ], "sae": [ 1, 143, 2, 145 ], "deaths": [ 0, 143, 0, 145 ], "timeframe": "Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8)." } ], "sae_pooled": { "rr": 1.0148445841840377, "lo": 0.8259572971754254, "hi": 1.2469283019469821, "k": 3, "i2": 0.25641202813623215, "tau2": 0.01320682314444829 }, "death_pooled": { "rr": 0.9534630408508642, "lo": 0.7976510615188186, "hi": 1.139711101916623, "k": 2, "i2": 0.05045564620637499, "tau2": 0.0055424744475472704 }, "sae_by_product": {}, "n_vaccine": 14344, "n_control": 14346 }, "rsv": { "trials": [ { "nct": "NCT04886596", "title": "Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above", "product_query": "RSVPreF3 OA", "active_arms": [ "RSV_annual Group" ], "control_arms": [ "Placebo Group" ], "sae": [ 796, 6243, 1660, 12503 ], "deaths": [ 120, 6243, 265, 12503 ], "timeframe": "Solicited AEs: during the 4-day follow-up period after any vaccination and unsolicited AEs: during the 30-day follow-up period after any vaccination. SAEs and pIMDs from Day 1 up to 6 months after any vaccination. All cause mortality, Fatal SAEs, Related SAEs and Related pIMDs were collected throughout the study period (From Day 1 up to approximately 3 years for NH and 2.5-3 years for SH)" }, { "nct": "NCT06551181", "title": "A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older", "product_query": "RSVPreF3 OA", "active_arms": [ "RSV OA Vaccine Group (Overseas)", "RSV OA Vaccine Group (China)" ], "control_arms": [ "Placebo Group (China)" ], "sae": [ 81, 2019, 38, 601 ], "deaths": [ 4, 2019, 0, 601 ], "timeframe": "Solicited AEs: Day 1 (day of vaccination) up to Day 7. Unsolicited AEs: Day 1 up to Day 30. All-cause mortality, any SAEs, related SAEs, fatal SAEs, any pIMDs, related pIMDs: Day 1 up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)" }, { "nct": "NCT05590403", "title": "A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above", "product_query": "RSVPreF3 OA", "active_arms": [ "Adults HA-RSV Group", "Adults AIR-RSV Group", "OA-RSV Group" ], "control_arms": [ "Adults HA-Placebo Group", "Adults AIR-Placebo Group" ], "sae": [ 27, 1150, 8, 383 ], "deaths": [ 1, 1150, 1, 383 ], "timeframe": "Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. SAEs and pIMDs were collected from Day 1 up to Month 6 post dose-administration. Related SAEs, related pIMDs and fatal SAEs were collected from Day 1 up to study end (Month 12)." }, { "nct": "NCT06614725", "title": "A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)", "product_query": "RSVPreF3 OA", "active_arms": [ "OA-RSV Group", "Adults-AIR-RSV Group" ], "control_arms": [ "OA-Placebo Group", "Adults-AIR-Placebo Group" ], "sae": [ 1, 500, 0, 250 ], "deaths": [ 0, 500, 0, 250 ], "timeframe": "Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6)." }, { "nct": "NCT04424316", "title": "A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.", "product_query": "RSVpreF", "active_arms": [ "Maternal Participants: RSVpreF", "Infant Participants: RSVpreF" ], "control_arms": [ "Maternal Participants: Placebo", "Infant Participants: Placebo" ], "sae": [ 1310, 7357, 1270, 7333 ], "deaths": [ 9, 7357, 14, 7333 ], "timeframe": "Maternal participants: Local reactions and systemic events: From Day 1 to Day 7 after vaccination; SAEs: From vaccination on Day 1 up to 6 months after delivery (maximum up to 10 months); Non-SAEs: From vaccination on Day 1 up to 1 month after vaccination; Infant participants: SAEs: From birth up to 24 months of age; Non-SAEs: From birth up to 1 month after birth" }, { "nct": "NCT05096208", "title": "Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to \u226449 Years of Age", "product_query": "RSVpreF", "active_arms": [ "Group 1: RSVpreF Lot 1", "Group 2: RSVpreF Lot 2", "Group 3: RSVpreF Lot 3", "RSVpreF Pooled Lots (Groups 1, 2 and 3)" ], "control_arms": [ "Placebo" ], "sae": [ 0, 1490, 0, 247 ], "deaths": [ 0, 1490, 0, 247 ], "timeframe": "Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)" }, { "nct": "NCT06325657", "title": "A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants", "product_query": "RSVpreF", "active_arms": [ "Maternal Participants: RSVpreF", "Infant Participants: RSVpreF" ], "control_arms": [ "Maternal Participants: Placebo", "Infant Participants: Placebo" ], "sae": [ 92, 343, 93, 336 ], "deaths": [ 2, 343, 5, 336 ], "timeframe": "Maternal participants: Local reactions and systemic events: From Day 1 to Day 7 after vaccination; SAEs and AESIs: From vaccination on Day 1 up to 6 months after delivery (maximum up to 10 months); Other AEs: From vaccination on Day 1 up to 1 month after vaccination; Infant participants: SAEs, AESIs and NDCMCs: From birth up to 6 months of age; Other AEs: From birth up to 1 month" }, { "nct": "NCT06593587", "title": "A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Older Adults in Korea", "product_query": "RSVpreF", "active_arms": [ "RSVpreF 120 mcg" ], "control_arms": [ "Placebo" ], "sae": [ 2, 251, 1, 126 ], "deaths": [ 0, 251, 0, 126 ], "timeframe": "All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination" }, { "nct": "NCT04785612", "title": "Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults", "product_query": "RSVpreF", "active_arms": [ "RSVPreF (From Vaccination Until Viral Challenge)", "RSVPreF (From Viral Challenge Until Day 28)", "RSVPreF (From Day 28 Until Day155)" ], "control_arms": [ "Placebo (From Vaccination Until Viral Challenge)", "Placebo (From Viral Challenge Until Day 28)", "Placebo (From Day 28 Until Day155)" ], "sae": [ 1, 105, 1, 105 ], "deaths": [ 0, 105, 0, 105 ], "timeframe": "Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155." }, { "nct": "NCT05127434", "title": "A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults \u226560 Years of Age", "product_query": "mRNA-1345", "active_arms": [ "Part A: mRNA-1345" ], "control_arms": [ "Part A: Placebo" ], "sae": [ 2773, 18369, 2745, 18316 ], "deaths": [ 301, 18427, 307, 18387 ], "timeframe": "All-cause mortality, SAEs, AESIs, MAAEs, and AEs led to study discontinuation: up to Month 24 (Part A) and up to BD Day 181 (Part B). Non-serious AEs: up to 28 days after study injection, unless they met criteria for AESIs, MAAEs, or AEs led to study discontinuation." }, { "nct": "NCT06097299", "title": "A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus", "product_query": "mRNA-1345", "active_arms": [ "Part A Cohort 1: mRNA-1345 Dose Level 1", "Part A Cohort 1: mRNA-1345 Dose Level 2", "Part A Cohort 1: mRNA-1345 Dose Level 3" ], "control_arms": [ "Part A Cohort 1: Placebo" ], "sae": [ 0, 121, 0, 41 ], "deaths": [ 0, 121, 0, 41 ], "timeframe": "All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation: up to Month 6 (Parts A & B). Other (non-serious) AEs: up to 28 days after study injection, unless they met criteria for AESIs, MAAEs, or AEs led to study discontinuation." } ], "sae_pooled": { "rr": 0.9981446527514743, "lo": 0.9637439986356064, "hi": 1.0337732315084034, "k": 11, "i2": 0.0, "tau2": 0.0 }, "death_pooled": { "rr": 0.9390249026040887, "lo": 0.8288593704353857, "hi": 1.0638327793138669, "k": 6, "i2": 0.0, "tau2": 0.0 }, "sae_by_product": { "RSVPreF3 OA": { "rr": 0.870807456132905, "lo": 0.6702092588652805, "hi": 1.1314460605043493, "k": 4, "i2": 0.3720681592566838, "tau2": 0.027279224836395628 }, "RSVpreF": { "rr": 1.022989276965236, "lo": 0.9563703609749227, "hi": 1.0942487382388644, "k": 5, "i2": 0.0, "tau2": 0.0 }, "mRNA-1345": { "rr": 1.0071178254848259, "lo": 0.9593062728591715, "hi": 1.0573122923362597, "k": 2, "i2": 0.0, "tau2": 0.0 } }, "n_vaccine": 37948, "n_control": 40241 }, "japanese-encephalitis": { "trials": [ { "nct": "NCT00596102", "title": "Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51", "product_query": "IC51", "active_arms": [ "IC51 Month 6", "JE-VAX", "IC51 Month 60" ], "control_arms": [ "Placebo" ], "sae": [ 31, 2723, 7, 637 ], "deaths": null, "timeframe": "all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60" }, { "nct": "NCT00605085", "title": "Safety and Tolerability of the Japanese Encephalitis Vaccine IC51", "product_query": "IC51", "active_arms": [ "IC51" ], "control_arms": [ "Placebo" ], "sae": [ 10, 1993, 6, 657 ], "deaths": null, "timeframe": null } ], "sae_pooled": { "rr": 0.8061260956593802, "lo": 0.4275628566481681, "hi": 1.5198684170027763, "k": 2, "i2": 0.0, "tau2": 0.0 }, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 4716, "n_control": 1294 }, "rabies": { "trials": [], "sae_pooled": null, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 0, "n_control": 0 }, "typhoid": { "trials": [], "sae_pooled": null, "death_pooled": null, "sae_by_product": {}, "n_vaccine": 0, "n_control": 0 }, "yellow-fever": { "trials": [ { "nct": "NCT01436396", "title": "Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers", "product_query": "Stamaril", "active_arms": [ "CYD Dengue Vaccine Group" ], "control_arms": [ "Placebo Group" ], "sae": [ 35, 394, 38, 393 ], "deaths": [ 0, 394, 1, 393 ], "timeframe": "Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days)." } ], "sae_pooled": { "rr": 0.918714934544483, "lo": 0.5932190350499542, "hi": 1.4228085767409648, "k": 1, "i2": 0.0, "tau2": 0.0 }, "death_pooled": { "rr": 0.33248945147679326, "lo": 0.013585260911154223, "hi": 8.137439248779687, "k": 1, "i2": 0.0, "tau2": 0.0 }, "sae_by_product": {}, "n_vaccine": 394, "n_control": 393 }, "cholera": { "trials": [ { "nct": "NCT02094586", "title": "A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults", "product_query": "PXVX0200", "active_arms": [ "PXVX0200 Lot A", "PXVX0200 Lot B", "PXVX0200 Lot C", "All PXVX0200 Lots" ], "control_arms": [ "Placebo" ], "sae": [ 40, 5578, 3, 350 ], "deaths": [ 2, 5578, 0, 350 ], "timeframe": "Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination." }, { "nct": "NCT02100631", "title": "A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults", "product_query": "PXVX0200", "active_arms": [ "PXVX0200 in Older Adults" ], "control_arms": [ "Placebo in Older Adults" ], "sae": [ 3, 296, 0, 99 ], "deaths": [ 0, 296, 0, 99 ], "timeframe": "Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit." }, { "nct": "NCT01895855", "title": "Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera", "product_query": "PXVX0200", "active_arms": [ "PVXV0200" ], "control_arms": [ "Placebo" ], "sae": [ 0, 95, 2, 102 ], "deaths": [ 0, 95, 0, 102 ], "timeframe": "Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181)." } ], "sae_pooled": { "rr": 0.8106363420238786, "lo": 0.2915984944843198, "hi": 2.253548257071645, "k": 3, "i2": 0.0, "tau2": 0.0 }, "death_pooled": { "rr": 0.31457250403298087, "lo": 0.015130489473116149, "hi": 6.540162528740695, "k": 1, "i2": 0.0, "tau2": 0.0 }, "sae_by_product": {}, "n_vaccine": 5969, "n_control": 551 } } }