{"id":"human-rotavirus-rix4414-strain-vaccine","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":"RIX4414 is an oral live attenuated vaccine containing a reassortant rotavirus derived from bovine and human rotavirus strains. Upon oral administration, the vaccine replicates in the intestinal epithelium, triggering both humoral (antibody) and cell-mediated immune responses. This generates protective immunity against wild-type rotavirus infection, particularly severe rotavirus gastroenteritis in infants and young children.","oneSentence":"This live attenuated rotavirus vaccine stimulates the immune system to produce antibodies and cellular immunity against rotavirus, preventing infection and severe gastroenteritis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:47:07.388Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of rotavirus gastroenteritis in infants and young children"}]},"trialDetails":[{"nctId":"NCT04658914","phase":"PHASE2","title":"Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa","status":"COMPLETED","sponsor":"Centre for Infectious Disease Research in Zambia","startDate":"2021-04-15","conditions":"Diarrhea, Diarrhea Rotavirus","enrollment":720},{"nctId":"NCT02941107","phase":"PHASE4","title":"Optimising Rotavirus Vaccine in Aboriginal Children","status":"ACTIVE_NOT_RECRUITING","sponsor":"Telethon Kids Institute","startDate":"2018-03-27","conditions":"Viral Gastroenteritis Due to Rotavirus","enrollment":1000},{"nctId":"NCT03632720","phase":"PHASE3","title":"Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2018-10-10","conditions":"Healthy Volunteers (Meningococcal Infection)","enrollment":788},{"nctId":"NCT04344054","phase":"PHASE2","title":"Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine","status":"COMPLETED","sponsor":"PATH","startDate":"2021-02-22","conditions":"Rotavirus Vaccine","enrollment":850},{"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":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Rotarix®"],"phase":"phase_3","status":"active","brandName":"Human rotavirus RIX4414 strain vaccine","genericName":"Human rotavirus RIX4414 strain vaccine","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi","modality":"Biologic","firstApprovalDate":"","aiSummary":"This live attenuated rotavirus vaccine stimulates the immune system to produce antibodies and cellular immunity against rotavirus, preventing infection and severe gastroenteritis. Used for Prevention of rotavirus gastroenteritis in infants and young children.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}