{"id":"modified-process-hepatitis-b-vaccine","safety":{"commonSideEffects":[{"rate":"10-30","effect":"Injection site pain or swelling"},{"rate":"1-6","effect":"Fever"},{"rate":"1-5","effect":"Fatigue"},{"rate":"1-5","effect":"Headache"},{"rate":"1-3","effect":"Myalgia"}]},"_chembl":{"chemblId":"CHEMBL2109163","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Modified Process Hepatitis B Vaccine is an inactivated vaccine containing hepatitis B surface antigen (HBsAg) produced through recombinant DNA technology. It works by presenting the viral antigen to the immune system, triggering both humoral (antibody) and cellular immune responses that confer protective immunity against hepatitis B infection. The vaccine is administered in a series of doses to establish and maintain adequate antibody titers.","oneSentence":"This vaccine stimulates the immune system to produce antibodies against hepatitis B surface antigen, providing protection against hepatitis B virus infection.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:21:52.970Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of hepatitis B infection in infants, children, and adults"}]},"trialDetails":[{"nctId":"NCT06058286","phase":"NA","title":"MENJAGA: Continuous Quality Improvement for Antenatal HIV, Syphilis and Hepatitis B Testing in Indonesia","status":"UNKNOWN","sponsor":"Yanri Wijayanti Subronto, MD, PhD,","startDate":"2023-10-01","conditions":"Hiv, Syphilis, Hepatitis B","enrollment":2000},{"nctId":"NCT05956379","phase":"NA","title":"Chronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention.","status":"ENROLLING_BY_INVITATION","sponsor":"National Taiwan University Hospital","startDate":"2023-08-01","conditions":"Chronic Hepatitis B, Non-alcoholic Fatty Liver Disease","enrollment":100},{"nctId":"NCT01251276","phase":"PHASE3","title":"Hepatitis B Challenge Dose in Adults (V232-059-10)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2010-11-30","conditions":"Hepatitis B","enrollment":204},{"nctId":"NCT03086564","phase":"PHASE1, PHASE2","title":"A Basic-clinical Translational Research in Hepatitis B Virus (HBV)-Specific Antigen Peptides and HepG2 Cell Lysate Co-activated Dendritic Cells Combined With Transarterial Chemoembolization (TACE) in HBV-related HCC Treatment (BTRHBVAPHCLCDCCTCHBVHCCT)","status":"COMPLETED","sponsor":"Yuehua Huang","startDate":"2017-05-01","conditions":"Hepatocellular Carcinoma","enrollment":70},{"nctId":"NCT01463683","phase":"PHASE3","title":"Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-11-29","conditions":"Hepatitis B","enrollment":722},{"nctId":"NCT00414050","phase":"PHASE3","title":"A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-10-06","conditions":"Hepatitis B","enrollment":1718},{"nctId":"NCT00440297","phase":"PHASE3","title":"Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-12","conditions":"Hepatitis B Virus Infection","enrollment":277},{"nctId":"NCT00440531","phase":"PHASE3","title":"Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-11","conditions":"Hepatitis B","enrollment":540},{"nctId":"NCT00393523","phase":"PHASE3","title":"Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-09","conditions":"Hepatitis B","enrollment":1478},{"nctId":"NCT00322361","phase":"PHASE2","title":"Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-05","conditions":"Hepatitis B, Hepatocellular Carcinoma","enrollment":566},{"nctId":"NCT00489099","phase":"PHASE3","title":"A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2005-06","conditions":"Hepatitis B Infection","enrollment":860},{"nctId":"NCT00441012","phase":"PHASE3","title":"Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-12","conditions":"Haemophilus Influenzae Type B, Hepatitis B","enrollment":546},{"nctId":"NCT00956891","phase":"","title":"Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSCs Transplantation","status":"COMPLETED","sponsor":"Sun Yat-sen University","startDate":"2005-05","conditions":"Liver Failure, Mesenchymal Stem Cells","enrollment":158}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["HBVaxPro"],"phase":"phase_3","status":"active","brandName":"Modified Process Hepatitis B Vaccine","genericName":"Modified Process Hepatitis B Vaccine","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Biologic","firstApprovalDate":"","aiSummary":"This vaccine stimulates the immune system to produce antibodies against hepatitis B surface antigen, providing protection against hepatitis B virus infection. Used for Prevention of hepatitis B infection in infants, children, and adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}