{"id":"rotavac","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal symptoms"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"ROTAVAC contains a weakened form of the rotavirus that causes the disease in humans. This weakened virus stimulates the body's immune system to produce antibodies that can fight off future infections. The vaccine is administered orally and provides protection against severe rotavirus diarrhea and dehydration.","oneSentence":"ROTAVAC is a live attenuated oral vaccine that protects against rotavirus infection.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:32:52.209Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of severe rotavirus diarrhea and dehydration 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},{"nctId":"NCT03602053","phase":"PHASE2, PHASE3","title":"Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia","status":"COMPLETED","sponsor":"Centre for Infectious Disease Research in Zambia","startDate":"2019-01-22","conditions":"Diarrhea, Diarrhea Rotavirus","enrollment":450},{"nctId":"NCT04596696","phase":"PHASE3","title":"Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam","status":"COMPLETED","sponsor":"Bharat Biotech International Limited","startDate":"2017-12-20","conditions":"Rotavirus Gastroenteritis","enrollment":360},{"nctId":"NCT03367559","phase":"PHASE3","title":"Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam","status":"UNKNOWN","sponsor":"Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products","startDate":"2018-02-08","conditions":"Rotavirus Infections","enrollment":360}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":96,"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®","genericName":"ROTAVAC®","companyName":"Centre for Infectious Disease Research in Zambia","companyId":"centre-for-infectious-disease-research-in-zambia","modality":"Biologic","firstApprovalDate":"","aiSummary":"ROTAVAC is a live attenuated oral vaccine that protects against rotavirus infection. Used for Prevention of severe rotavirus diarrhea and dehydration in infants and young children.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":2,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}