{"id":"active-comparator-hepatitis-b-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain or swelling"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Hepatitis B vaccines work by presenting hepatitis B surface antigen (HBsAg) to the immune system, triggering both humoral (antibody) and cell-mediated immune responses. This primes the body to recognize and neutralize hepatitis B virus upon exposure, preventing infection and chronic disease. The vaccine formulation from Jiangsu CDC likely contains recombinant HBsAg or similar immunogenic components.","oneSentence":"A hepatitis B vaccine that stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus surface antigen.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:59:13.827Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of hepatitis B infection"}]},"trialDetails":[{"nctId":"NCT06000657","phase":"PHASE4","title":"Efficacy and Safety of Switching to Vemliver From Entecavir in Chronic Hepatitis B Patients Previously Treated With Entecavir","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2023-08-28","conditions":"Hepatitis B, Chronic","enrollment":196},{"nctId":"NCT06800131","phase":"PHASE1","title":"Hepatitis B Vaccine Delivered Trans-dermally by MAP","status":"NOT_YET_RECRUITING","sponsor":"International Vaccine Institute","startDate":"2025-02-05","conditions":"Hepatitis B Vaccine","enrollment":40},{"nctId":"NCT02942277","phase":"PHASE1","title":"Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2016-10-21","conditions":"Malaria","enrollment":301},{"nctId":"NCT04629976","phase":"PHASE1","title":"Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic Hepatitis B","status":"COMPLETED","sponsor":"Nucorion Pharmaceuticals, Inc.","startDate":"2021-01-12","conditions":"Chronic Hepatitis B","enrollment":21},{"nctId":"NCT04248426","phase":"PHASE1","title":"A Phase 1 Double-Blinded Study for Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ATI-2173 in Healthy Subjects and Subjects With Chronic Hepatitis B Virus Infection","status":"COMPLETED","sponsor":"Antios Therapeutics, Inc","startDate":"2020-02-05","conditions":"Hepatitis B, Chronic","enrollment":88},{"nctId":"NCT03408730","phase":"PHASE3","title":"Lot-to-lot Consistency of Sci-B-Vac™ in Adults","status":"COMPLETED","sponsor":"VBI Vaccines Inc.","startDate":"2017-12-14","conditions":"Hepatitis B Vaccines","enrollment":2838},{"nctId":"NCT03110757","phase":"PHASE1","title":"A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2018-05-20","conditions":"Schistosomiasis","enrollment":60},{"nctId":"NCT01341639","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)","status":"COMPLETED","sponsor":"MCM Vaccines B.V.","startDate":"2011-05-26","conditions":"Bacterial Infections, Virus Diseases","enrollment":1250},{"nctId":"NCT01480258","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)","status":"COMPLETED","sponsor":"MCM Vaccines B.V.","startDate":"2011-11-23","conditions":"Bacterial Infections, Virus Diseases","enrollment":1315},{"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":"NCT02826018","phase":"PHASE1","title":"A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection","status":"TERMINATED","sponsor":"Alnylam Pharmaceuticals","startDate":"2016-06-24","conditions":"Hepatitis B, Chronic Hepatitis B, Hepatitis B, Chronic","enrollment":24},{"nctId":"NCT00388674","phase":"","title":"Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2006-12-18","conditions":"Chronic Hepatitis B","enrollment":12522},{"nctId":"NCT02805738","phase":"PHASE3","title":"Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet","status":"UNKNOWN","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2016-04","conditions":"Chronic Hepatitis B","enrollment":158},{"nctId":"NCT01896739","phase":"PHASE3","title":"A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants","status":"COMPLETED","sponsor":"LG Life Sciences","startDate":"2009-08","conditions":"Healthy Infants","enrollment":289},{"nctId":"NCT01595633","phase":"PHASE4","title":"Switch From Adefovir to Tenofovir in Chronic Hepatitis B for Suboptimal Response to Adefovir-based Combination Therapy","status":"UNKNOWN","sponsor":"Yonsei University","startDate":"2012-03","conditions":"Chronic Hepatitis B","enrollment":124},{"nctId":"NCT00606099","phase":"PHASE4","title":"Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B","status":"WITHDRAWN","sponsor":"Novartis","startDate":"2007-11","conditions":"Chronic Hepatitis B","enrollment":""},{"nctId":"NCT01183611","phase":"PHASE3","title":"The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates","status":"COMPLETED","sponsor":"Jiangsu Province Centers for Disease Control and Prevention","startDate":"2007-04","conditions":"Virus Disease, DNA Virus Infections, Hepadnaviridae Infections","enrollment":1740},{"nctId":"NCT00387569","phase":"PHASE1","title":"Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers","status":"COMPLETED","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","startDate":"2006-10","conditions":"Healthy","enrollment":99}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":175,"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":"Active Comparator hepatitis B vaccine","genericName":"Active Comparator hepatitis B vaccine","companyName":"Jiangsu Province Centers for Disease Control and Prevention","companyId":"jiangsu-province-centers-for-disease-control-and-prevention","modality":"Biologic","firstApprovalDate":"","aiSummary":"The Active Comparator hepatitis B vaccine, also known as CKD-390, is being studied in clinical trials for its efficacy and safety in treating Chronic Hepatitis B and preventing Hepatitis B in Healthy Infants. The mechanism of action of CKD-390 is not specified in the provided information, but it is being compared to other interventions such as viread and Eutravac in clinical trials.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}