{"id":"recombivax-hb","safety":{"commonSideEffects":[{"rate":"25-29%","effect":"Injection site soreness or swelling"},{"rate":"14-17%","effect":"Fatigue"},{"rate":"12-15%","effect":"Headache"},{"rate":"1-6%","effect":"Fever (≥37.7°C)"},{"rate":"5-17%","effect":"Myalgia"}]},"_chembl":{"chemblId":"CHEMBL470950","moleculeType":"Small molecule","molecularWeight":"460.61"},"_dailymed":{"setId":"b5bd99e4-569d-48d5-ba75-16e69f8c409a","title":"RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains recombinant hepatitis B surface antigen produced in yeast cells via recombinant DNA technology. When administered, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) and memory B cells. This immunological memory provides long-term protection against hepatitis B infection.","oneSentence":"RECOMBIVAX HB is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg), providing protection against hepatitis B virus infection.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:31:40.445Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of hepatitis B infection in infants, children, and adults"},{"name":"Post-exposure prophylaxis for hepatitis B"}]},"trialDetails":[{"nctId":"NCT03893448","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-06-19","conditions":"Pneumococcal Infections, Pneumococcal Vaccines","enrollment":1720},{"nctId":"NCT03620162","phase":"PHASE3","title":"A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2018-10-18","conditions":"Pneumococcal Infections","enrollment":900},{"nctId":"NCT01340937","phase":"PHASE3","title":"A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-05-10","conditions":"Bacterial Infections, Virus Diseases","enrollment":2808},{"nctId":"NCT01337167","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-04-19","conditions":"Bacterial Infections, Virus Diseases","enrollment":1473},{"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":"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":"NCT00551915","phase":"PHASE2","title":"A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months of Age (V419-003)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2001-05","conditions":"Bacterial Infections; Virus Diseases","enrollment":756}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":73,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced."],"phase":"marketed","status":"active","brandName":"RECOMBIVAX HB™","genericName":"RECOMBIVAX HB™","companyName":"Merck Sharp & Dohme LLC","companyId":"merck-sharp-dohme-llc","modality":"Biologic","firstApprovalDate":"","aiSummary":"RECOMBIVAX HB is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg), providing protection against hepatitis B virus infection. Used for Prevention of hepatitis B infection in infants, children, and adults, Post-exposure prophylaxis for hepatitis B.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}