{"id":"rotavac-5c-f1","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is a pentavalent rotavirus vaccine candidate developed by Bharat Biotech containing five rotavirus strains (G1, G2, G3, G4, and G9). It works by introducing weakened rotavirus particles that trigger both humoral and mucosal immune responses, enabling the body to recognize and neutralize wild-type rotavirus before infection occurs. The vaccine is designed to provide broad protection against the most clinically relevant rotavirus genotypes.","oneSentence":"ROTAVAC 5C-F1 is a live attenuated rotavirus vaccine that stimulates immune responses against rotavirus to prevent gastroenteritis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:32:57.971Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of rotavirus gastroenteritis in infants and young children"}]},"trialDetails":[{"nctId":"NCT04819412","phase":"PHASE3","title":"To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus","status":"COMPLETED","sponsor":"Bharat Biotech International Limited","startDate":"2015-03-20","conditions":"Rotavirus Gastroenteritis","enrollment":1975}],"_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":"ROTAVAC 5C -F1","genericName":"ROTAVAC 5C -F1","companyName":"Bharat Biotech International Limited","companyId":"bharat-biotech-international-limited","modality":"Biologic","firstApprovalDate":"","aiSummary":"ROTAVAC 5C-F1 is a live attenuated rotavirus vaccine that stimulates immune responses against rotavirus to prevent gastroenteritis. Used for Prevention of rotavirus gastroenteritis in infants and young children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}