{"id":"hrv-pcv-free-liquid-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Irritability"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Loss of appetite"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"HRV PCV-free liquid vaccine is a rotavirus vaccine candidate designed to protect against rotavirus infection through active immunization. The 'PCV-free' designation indicates this formulation excludes pneumococcal conjugate vaccine components, distinguishing it from combination vaccine approaches. As a liquid formulation in phase 3 development, it aims to provide convenient administration while maintaining immunogenicity against rotavirus strains.","oneSentence":"This is a liquid rotavirus vaccine formulation that provides immunization against human rotavirus without pneumococcal conjugate vaccine (PCV) components.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:45:59.320Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of rotavirus gastroenteritis in infants and young children"}]},"trialDetails":[{"nctId":"NCT06331156","phase":"PHASE3","title":"A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2024-03-22","conditions":"Gastroenteritis","enrollment":400},{"nctId":"NCT06025695","phase":"PHASE3","title":"Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2023-09-01","conditions":"Gastroenteritis","enrollment":2000},{"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":"NCT02914184","phase":"PHASE3","title":"Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-10-27","conditions":"Infections, Rotavirus, Rotavirus Vaccines","enrollment":1612}],"_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":[],"phase":"phase_3","status":"active","brandName":"HRV PCV-free liquid vaccine","genericName":"HRV PCV-free liquid vaccine","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"This is a liquid rotavirus vaccine formulation that provides immunization against human rotavirus without pneumococcal conjugate vaccine (PCV) components. 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}}