{"id":"orv-116e","safety":{"commonSideEffects":[{"rate":null,"effect":"Mild diarrhea"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ORV 116E is a live attenuated rotavirus vaccine developed by Bharat Biotech for oral administration. It aims to induce mucosal and systemic immune responses to protect against rotavirus gastroenteritis, particularly in infants and young children in resource-limited settings.","oneSentence":"ORV 116E is an oral rotavirus vaccine candidate designed to provide immunization against rotavirus infection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:50.016Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of rotavirus gastroenteritis in infants and children"}]},"trialDetails":[{"nctId":"NCT01305109","phase":"PHASE3","title":"A Phase III Clinical Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E","status":"UNKNOWN","sponsor":"Bharat Biotech International Limited","startDate":"2011-03","conditions":"Viral Gastroenteritis Due to Rotavirus","enrollment":6800}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ROTAVAC"],"phase":"phase_3","status":"active","brandName":"ORV 116E","genericName":"ORV 116E","companyName":"Bharat Biotech International Limited","companyId":"bharat-biotech-international-limited","modality":"Biologic","firstApprovalDate":"","aiSummary":"ORV 116E is an oral rotavirus vaccine candidate designed to provide immunization against rotavirus infection. Used for Prevention of rotavirus gastroenteritis in infants and children.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}