{"id":"rotarix-dpt-hepb-hib-opv","safety":{"commonSideEffects":[{"rate":"5-15","effect":"Fever"},{"rate":"5-10","effect":"Irritability"},{"rate":"5-20","effect":"Injection site pain/swelling"},{"rate":"2-5","effect":"Diarrhea"},{"rate":"1-3","effect":"Vomiting"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ROTARIX is a live attenuated rotavirus vaccine that induces mucosal and systemic immunity against rotavirus gastroenteritis. The DPT-HepB-Hib component is an inactivated pentavalent vaccine containing toxoids and recombinant antigens that stimulate humoral immunity against diphtheria, pertussis, tetanus, hepatitis B, and Haemophilus influenzae type b. OPV (oral poliomyelitis vaccine) is a live attenuated vaccine that provides immunity against poliovirus types 1, 2, and 3 through mucosal and systemic immune responses.","oneSentence":"This combination vaccine provides immunization against rotavirus, diphtheria, pertussis, tetanus, hepatitis B, Haemophilus influenzae type b, and poliomyelitis through inactivated and live attenuated viral/bacterial antigens.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:32:51.351Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of rotavirus gastroenteritis in infants"},{"name":"Prevention of diphtheria, pertussis, tetanus in infants and children"},{"name":"Prevention of hepatitis B in infants and children"},{"name":"Prevention of Haemophilus influenzae type b infection in infants and children"},{"name":"Prevention of poliomyelitis in infants and children"}]},"trialDetails":[{"nctId":"NCT02584816","phase":"PHASE3","title":"Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization","status":"COMPLETED","sponsor":"Serum Institute of India Pvt. Ltd.","startDate":"2015-11","conditions":"Rotavirus Gastroenteritis","enrollment":1500}],"_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":"ROTARIX + DPT-HepB-Hib + OPV","genericName":"ROTARIX + DPT-HepB-Hib + OPV","companyName":"Serum Institute of India Pvt. Ltd.","companyId":"serum-institute-of-india-pvt-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"This combination vaccine provides immunization against rotavirus, diphtheria, pertussis, tetanus, hepatitis B, Haemophilus influenzae type b, and poliomyelitis through inactivated and live attenuated viral/bacterial antigens. Used for Prevention of rotavirus gastroenteritis in infants, Prevention of diphtheria, pertussis, tetanus in infants and children, Prevention of hepatitis B in infants and children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}