{"id":"fendrix-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain"},{"rate":null,"effect":"Injection site erythema"},{"rate":null,"effect":"Injection site swelling"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fendrix contains recombinant hepatitis B surface antigen (HBsAg) combined with the AS04 adjuvant, which comprises aluminum hydroxide and MPL (monophosphoryl lipid A). This adjuvant system enhances both cellular and humoral immune responses, resulting in higher and more durable antibody titers compared to non-adjuvanted hepatitis B vaccines. The vaccine is designed to provide improved protection, particularly in populations with reduced immune response such as dialysis patients.","oneSentence":"Fendrix is a recombinant hepatitis B vaccine that stimulates immune response against hepatitis B surface antigen using an AS04 adjuvant system to enhance immunogenicity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:31.328Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of hepatitis B infection in adults with renal insufficiency, including pre-dialysis and dialysis patients"},{"name":"Prevention of hepatitis B in other immunocompromised populations"}]},"trialDetails":[{"nctId":"NCT03866187","phase":"PHASE1, PHASE2","title":"Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2019-03-28","conditions":"Hepatitis B, Chronic","enrollment":236},{"nctId":"NCT05705427","phase":"PHASE4","title":"The COMBAT HBV Feasibility Trial","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2023-08-17","conditions":"Hepatitis B, Vertical Transmission of Infectious Disease","enrollment":317},{"nctId":"NCT06507605","phase":"PHASE1","title":"Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults","status":"COMPLETED","sponsor":"Serum Institute of India Pvt. 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