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.
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.
Joines
R W
RW
GlaxoSmithKline, Philadelphia, PA, USA.
Blatter
M
M
Abraham
B
B
Xie
F
F
De Clercq
N
N
Baine
Y
Y
Reisinger
K S
KS
Kuhnen
A
A
Parenti
D L
DL
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*
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