{"id":"rotavirus-vaccine-brv-pv","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability"}]},"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains weakened rotavirus strains that replicate in the intestinal tract, triggering both humoral and mucosal immune responses without causing severe disease. This primes the immune system to recognize and neutralize wild-type rotavirus upon natural exposure, preventing infection or reducing disease severity.","oneSentence":"BRV-PV is a live attenuated rotavirus vaccine that stimulates immune responses to prevent rotavirus gastroenteritis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:52:31.648Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of rotavirus gastroenteritis in infants and young children"}]},"trialDetails":[{"nctId":"NCT02145000","phase":"PHASE3","title":"Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger","status":"COMPLETED","sponsor":"Epicentre","startDate":"2014-06","conditions":"Severe Rotavirus Gastroenteritis","enrollment":6586},{"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},{"nctId":"NCT02133690","phase":"PHASE3","title":"A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants","status":"COMPLETED","sponsor":"Serum Institute of India Pvt. Ltd.","startDate":"2014-05","conditions":"Rotavirus Gastroenteritis","enrollment":7500},{"nctId":"NCT03474055","phase":"PHASE2, PHASE3","title":"Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India","status":"COMPLETED","sponsor":"Serum Institute of India Pvt. Ltd.","startDate":"2017-10-30","conditions":"Rotavirus Gastroenteritis","enrollment":1500}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"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":"Rotavirus vaccine (BRV-PV)","genericName":"Rotavirus vaccine (BRV-PV)","companyName":"Epicentre","companyId":"epicentre","modality":"Biologic","firstApprovalDate":"","aiSummary":"BRV-PV is a live attenuated rotavirus vaccine that stimulates immune responses to prevent rotavirus gastroenteritis. Used for Prevention of rotavirus gastroenteritis in infants and young children.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}