{"id":"hrv-lyophilized","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability"}]},"_chembl":{"chemblId":"CHEMBL1631334","moleculeType":"Oligonucleotide","molecularWeight":"9975.27"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains a weakened form of human rotavirus that replicates in the intestinal tract, triggering both humoral and mucosal immune responses. This primes the immune system to recognize and neutralize wild-type rotavirus upon natural exposure, preventing severe gastroenteritis in infants and young children.","oneSentence":"HRV Lyophilized is a live attenuated human rotavirus vaccine that stimulates immune responses against rotavirus infection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:45:50.509Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of rotavirus gastroenteritis in infants and young children"}]},"trialDetails":[{"nctId":"NCT03954743","phase":"PHASE3","title":"Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-07-19","conditions":"Infections, Rotavirus","enrollment":1351},{"nctId":"NCT03207750","phase":"PHASE3","title":"This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-09-14","conditions":"Rotavirus Infection, Rotavirus Vaccines","enrollment":1280},{"nctId":"NCT02141204","phase":"PHASE3","title":"Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-02-20","conditions":"Rotavirus","enrollment":451},{"nctId":"NCT00363545","phase":"PHASE3","title":"To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-09-01","conditions":"Infections, Rotavirus","enrollment":1274}],"_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":"HRV Lyophilized","genericName":"HRV Lyophilized","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"HRV Lyophilized is a live attenuated human rotavirus vaccine that stimulates immune responses against rotavirus infection. Used for Prevention of 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}}