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aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1)."},{"id":"FG005","title":"Cohort 2 (Group 4) + Cohort 3 (Group 2): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)","description":"Participants aged more than (\\>) 55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1)."},{"id":"FG006","title":"Cohort 2 (Group 5): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)","description":"Participants aged \\>55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1)."},{"id":"FG007","title":"Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4 /BA.5] 30 mcg)","description":"Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1)."},{"id":"FG008","title":"Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)","description":"Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1)."},{"id":"FG009","title":"Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)","description":"Participants aged 18-55 years received BNT162b6 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1)."},{"id":"FG010","title":"Cohort 4: 18-55 Years (BNT162b7 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)","description":"Participants aged 18-55 years received BNT162b7 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1)."},{"id":"FG011","title":"Cohort 4: 18-55 Years (BNT162b7 Monovalent [OMI BA.4/ BA.5] 30 mcg)","description":"Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1)."}],"acronym":null,"periods":[{"title":"Overall 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Cohort 1 and 4 had distinct participant groups and objectives. Where appropriate, and as per planned analyses, data is summarized and combined for Cohort 2 (C2) and Cohort 3 (C3) 30 micrograms (mcg) groups (G) per age category to provide sufficient power for the immunogenicity hypotheses for each of the age groups.","preAssignment":"Study consisted of 4 cohorts. Cohort 1 and 4 had distinct participant groups and objectives, while cohorts are different, they are part of same study. Both arms (Cohort 2 Group 2 and Cohort 3 Group 1) and (Cohort 2 Group 4 and Cohort 3 Group 2) received the same treatment and are from the same age group. As mentioned in the Protocol Objective section, arms with the same treatment and age group will be combined to provide a more comprehensive summary, rather than being listed in separate columns."}],"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"structuredTrialResults":[{"hr":"2.91","nctId":"NCT05472038","phase":"PHASE2, PHASE3","pValue":"","ciLower":"2.45","ciUpper":"3.44","endpoint":"GMR of Omicron (BA.4/BA.5)- NT of BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg Cohort 2 (Group 4)/ Cohort 3 (Group 2) Combined in C4591044 Compared to NT of BNT162b2 30 mcg in C4591031 [NCT04955626]- 1 Month After Vaccination Among Participants >55 Years","enrollment":1453}],"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"vaccine","firstApprovalDate":"","enrichmentLevel":5,"visitCount":8,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":""},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":1,"withResults":1},"validation":{"fieldsValidated":4,"lastValidatedAt":"2026-04-20T08:53:12.016663+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}