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.
Publication types
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Clinical Trial
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Comparative Study
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Randomized Controlled Trial
MeSH terms
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Adult
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Erythema / etiology
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Female
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Gastrointestinal Diseases / etiology
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Headache / etiology
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Hepatitis A Antibodies
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Hepatitis A Vaccines / adverse effects
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Hepatitis A Vaccines / immunology*
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Hepatitis Antibodies / biosynthesis
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Hepatitis Antibodies / immunology
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Hepatitis B Antibodies / biosynthesis
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Hepatitis B Antibodies / immunology
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Hepatitis B Surface Antigens / immunology
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Hepatitis B Vaccines / adverse effects
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Hepatitis B Vaccines / immunology*
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Humans
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Immunization Schedule
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Male
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Pain / etiology
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Prospective Studies
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Safety
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United States
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Vaccination
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Vaccines, Combined
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Vaccines, Synthetic / adverse effects
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Vaccines, Synthetic / immunology*
Substances
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Engerix-B
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Hepatitis A Antibodies
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Hepatitis A Vaccines
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Hepatitis Antibodies
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Hepatitis B Antibodies
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Hepatitis B Surface Antigens
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Hepatitis B Vaccines
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Vaccines, Combined
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Vaccines, Synthetic
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twinrix