{"id":"brv-pv-lot-c-dpt-hepb-hib-opv","safety":{"commonSideEffects":[{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Local injection site reactions (pain, swelling, erythema)"},{"rate":null,"effect":"Irritability"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Vomiting"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BRV-PV (Rotavirus vaccine) stimulates immune response against rotavirus antigens to prevent rotavirus gastroenteritis. The DPT-HepB-Hib component provides immunization against diphtheria toxoid, pertussis antigens, tetanus toxoid, hepatitis B surface antigen, and Haemophilus influenzae type b polysaccharide conjugate. OPV (Oral Polio Vaccine) contains live attenuated poliovirus strains that induce mucosal and systemic immunity against poliovirus types 1, 2, and 3.","oneSentence":"This is a combination vaccine that provides immunization against rotavirus (BRV-PV), diphtheria, pertussis, tetanus, hepatitis B, Haemophilus influenzae type b, and poliomyelitis through active immune stimulation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:51:10.981Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of rotavirus gastroenteritis in infants"},{"name":"Prevention of diphtheria, pertussis, and tetanus"},{"name":"Prevention of hepatitis B infection"},{"name":"Prevention of Haemophilus influenzae type b infection"},{"name":"Prevention of poliomyelitis"}]},"trialDetails":[{"nctId":"NCT02584816","phase":"PHASE3","title":"Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization","status":"COMPLETED","sponsor":"Serum Institute of India Pvt. Ltd.","startDate":"2015-11","conditions":"Rotavirus Gastroenteritis","enrollment":1500}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"BRV-PV Lot C + DPT-HepB-Hib + OPV","genericName":"BRV-PV Lot C + DPT-HepB-Hib + OPV","companyName":"Serum Institute of India Pvt. Ltd.","companyId":"serum-institute-of-india-pvt-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"This is a combination vaccine that provides immunization against rotavirus (BRV-PV), diphtheria, pertussis, tetanus, hepatitis B, Haemophilus influenzae type b, and poliomyelitis through active immune stimulation. Used for Prevention of rotavirus gastroenteritis in infants, Prevention of diphtheria, pertussis, and tetanus, Prevention of hepatitis B infection.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}