title: A prospective, randomized, comparative US trial of a combination hepatitis A and B vaccine (Twinrix) with corresponding monovalent vaccines (Havrix and Engerix-B) in adults.
abstract: In an open, randomized, multicenter, controlled clinical trial in the US, 773 adults were administered either a combination hepatitis vaccine (Twinrix: 720 EL.U inactivated hepatitis A antigen and 20 mcg recombinant hepatitis B surface antigen per milliliter) on a 0, 1, 6 month schedule or corresponding monovalent vaccines concurrently (Havrix, 1440 EL.U/ml of hepatitis A antigen at 0, 6 months and Engerix-B, 20 mcg of hepatitis B surface antigen at 0, 1, 6 months). Non-inferiority testing for the primary endpoint, severe soreness, and equivalence testing for the secondary endpoints, anti-HAV seroconversion and anti-HBs seroprotection, showed that safety and immunogenicity were comparable in the two groups.
authors.affiliation: GlaxoSmithKline, Philadelphia, PA, USA.
authors.forename: R W
authors.initials: RW
authors.lastname: Joines
authors.forename: M
authors.initials: M
authors.lastname: Blatter
authors.forename: B
authors.initials: B
authors.lastname: Abraham
authors.forename: F
authors.initials: F
authors.lastname: Xie
authors.forename: N
authors.initials: N
authors.lastname: De Clercq
authors.forename: Y
authors.initials: Y
authors.lastname: Baine
authors.forename: K S
authors.initials: KS
authors.lastname: Reisinger
authors.forename: A
authors.initials: A
authors.lastname: Kuhnen
authors.forename: D L
authors.initials: DL
authors.lastname: Parenti
mesh_terms: D000328:Adult; D004890:Erythema / Q000209:etiology; D005260:Female; D005767:Gastrointestinal Diseases / Q000209:etiology; D006261:Headache / Q000209:etiology; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines / Q000009:adverse effects / Q000276:immunology*; D006508:Hepatitis Antibodies / Q000096:biosynthesis / Q000276:immunology; D006510:Hepatitis B Antibodies / Q000096:biosynthesis / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D010146:Pain / Q000209:etiology; D011446:Prospective Studies; D012449:Safety; D014481:United States; D014611:Vaccination; D017778:Vaccines, Combined; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology*
chemical_list: C075654:Engerix-B; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006508:Hepatitis Antibodies; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined; D014614:Vaccines, Synthetic; C433226:twinrix