{"id":"rotarix-tm","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Rotarix contains a single strain of live attenuated human rotavirus (RIX4414) 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":"2026-03-28T00:06:07.606Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of rotavirus gastroenteritis in infants and young children"}]},"trialDetails":[{"nctId":"NCT01177826","phase":"","title":"Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-02-23","conditions":"Infections, Rotavirus, Rotavirus Vaccines","enrollment":643},{"nctId":"NCT01198769","phase":"PHASE4","title":"Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-11-11","conditions":"Infections, Rotavirus","enrollment":15},{"nctId":"NCT00808444","phase":"PHASE3","title":"Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-01-05","conditions":"Infections, Streptococcal","enrollment":466},{"nctId":"NCT03031743","phase":"","title":"The Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan","status":"COMPLETED","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2014-01","conditions":"Rotavirus","enrollment":88}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":9,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Rotarix TM","genericName":"Rotarix TM","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","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":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}