{"id":"rotavac-5d","safety":{"commonSideEffects":[{"rate":"null","effect":"Injection site pain"},{"rate":"null","effect":"Fever"},{"rate":"null","effect":"Vomiting"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"ROTAVAC 5D works by inducing an immune response against rotavirus, thereby preventing the infection from taking hold in the body. This is achieved through the introduction of weakened rotavirus antigens, which stimulate the body's immune system to produce antibodies and immune cells that can recognize and neutralize the virus. By providing long-term immunity, ROTAVAC 5D helps to prevent severe rotavirus gastroenteritis in infants and young children.","oneSentence":"ROTAVAC 5D is a vaccine that protects against rotavirus infection.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:32:57.783Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of severe rotavirus gastroenteritis in infants and young children"}]},"trialDetails":[{"nctId":"NCT06200844","phase":"PHASE3","title":"The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bharat Biotech International Limited","startDate":"2023-07-07","conditions":"Rotavirus Infection of Children","enrollment":5800},{"nctId":"NCT05958771","phase":"PHASE3","title":"The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E","status":"UNKNOWN","sponsor":"University of Chile","startDate":"2023-07-06","conditions":"Rotavirus Gastroenteritis","enrollment":5800},{"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}],"_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":"ROTAVAC 5D","genericName":"ROTAVAC 5D","companyName":"Centre for Infectious Disease Research in Zambia","companyId":"centre-for-infectious-disease-research-in-zambia","modality":"Biologic","firstApprovalDate":"","aiSummary":"ROTAVAC 5D is a vaccine that protects against rotavirus infection. Used for Prevention of severe rotavirus gastroenteritis in infants and young children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}