{"id":"rotarix-rv1","safety":{"commonSideEffects":[{"rate":"5-10","effect":"Diarrhea"},{"rate":"3-7","effect":"Vomiting"},{"rate":"2-5","effect":"Fever"},{"rate":"5-10","effect":"Irritability"},{"rate":"0.01-0.1","effect":"Intussusception (rare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Rotarix contains a single strain of live attenuated human rotavirus (RV1) that replicates in the intestinal tract, triggering both humoral and mucosal immune responses. This vaccination prevents severe rotavirus gastroenteritis by inducing protective antibodies and T-cell mediated immunity against the virus. The vaccine provides cross-protection against multiple rotavirus genotypes through immune memory.","oneSentence":"Rotarix is a live attenuated rotavirus vaccine that stimulates the immune system to produce antibodies and cellular immunity against rotavirus infection.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:06:08.705Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of rotavirus gastroenteritis in infants and young children"}]},"trialDetails":[{"nctId":"NCT01871038","phase":"","title":"Effectiveness of Monovalent Rotavirus Vaccine (RV1)","status":"COMPLETED","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"2009-07","conditions":"Rotavirus, Acute Gastroenteritis","enrollment":362},{"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":"NCT02193061","phase":"PHASE3","title":"Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs","status":"COMPLETED","sponsor":"National Institute of Pediatrics, Mexico","startDate":"2013-11","conditions":"Rotavirus Vaccine","enrollment":1498},{"nctId":"NCT02542462","phase":"PHASE4","title":"Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study","status":"COMPLETED","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"2015-11","conditions":"Intussusception, Rotavirus Infections","enrollment":144}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":115,"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":"marketed","status":"active","brandName":"Rotarix (RV1)","genericName":"Rotarix (RV1)","companyName":"Telethon Kids Institute","companyId":"telethon-kids-institute","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Rotarix is a live attenuated rotavirus vaccine that stimulates the immune system to produce antibodies and cellular immunity against rotavirus infection. Used for Prevention of rotavirus gastroenteritis in infants and young children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}