Published online September 1, 2006
PEDIATRICS Vol. 118 No. 3 September 2006, pp. e602-e609 (doi:10.1542/peds.2005-2755)
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ARTICLE

Immunogenicity and Safety of an Inactivated Hepatitis A Vaccine Administered Concomitantly With Diphtheria-Tetanus-Acellular Pertussis and Haemophilus influenzae Type B Vaccines to Children Less Than 2 Years of Age

Terry Nolan, MBBS, PhDa, Henry Bernstein, DOb, Mark M. Blatter, MDc, Kenneth Bromberg, MDd, Fernando Guerra, MD, MPHe, William Kennedy, MDf, Michael Pichichero, MDg, Shelly D. Senders, MDh, Andrew Trofa, MDi, Alix Collard, PhDj, Diane C. Sullivan, RNi and Dominique Descamps, MDj

a School of Population Health, University of Melbourne and Murdoch Children's Research Institute, Victoria, Australia
b Dartmouth Medical School, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
c Primary Physicians Research, Pittsburgh, Pennsylvania
d State University of New York, Health Science Center at Brooklyn, Vaccine Study Center, Brooklyn, New York
e Main Immunization Clinic, San Antonio, Texas
f University of California Los Angeles Center for Vaccine Research, Los Angeles Biomedical Research Institute at Harbor-University of California Los Angeles Medical Center, Torrance, California
g University of Rochester Medical Center, Rochester, New York
h Dr Shelly Senders & Associates, University Heights, Ohio
i GlaxoSmithKline, King of Prussia, Pennsylvania
j GlaxoSmithKline, Rixensart, Belgium

OBJECTIVE. The availability of a hepatitis A virus vaccine for infant and early childhood immunization could reduce the transmission of hepatitis A virus in the United States. This study evaluated the immunogenicity and safety of a hepatitis A virus vaccine (Havrix, GlaxoSmithKline Biologicals, Rixensart, Belgium) administered concomitantly with diphtheria-tetanus-acellular pertussis and Haemophilus influenzae type b vaccines to children <2 years.

METHODS. In this open, comparative, multicenter study, 1084 healthy children aged 11 to 25 months were allocated (4:4:3:3:4 ratio) to 5 treatment groups based on age and previous vaccination history. Subjects 11 to 13 months of age received 2 doses of hepatitis A virus vaccine 6 months apart (N = 243). Subjects aged 15 to 18 months received 2 doses of hepatitis A virus vaccine 6 months apart (N = 241); or hepatitis A virus vaccine, diphtheria-tetanus-acellular pertussis, and H influenzae type b at month 0 and the second dose of hepatitis A virus vaccine 6 months later (N = 183); or diphtheria-tetanus-acellular pertussis and H influenzae type b at month 0 and hepatitis A virus vaccine at months 1 and 7 (N = 175). Subjects 23 to 25 months of age received hepatitis A virus vaccine at months 0 and 6 (N = 242). Immune responses were measured at baseline and 30 days after vaccine doses, and solicited and unsolicited adverse events were collected.

RESULTS. After 2 doses of hepatitis A virus vaccine, all of the subjects in all of the groups were seropositive. Coadministration of hepatitis A virus vaccine with diphtheria-tetanus-acellular pertussis and H influenzae type b vaccines did not impact the immunogenicity of the 3 vaccines, except for the antipertussis toxoid vaccine response, which was slightly decreased. Hepatitis A virus vaccine was well tolerated in children 11 to 25 months of age.

CONCLUSION. The administration of 2 doses of hepatitis A virus vaccine on a 0- and 6-month schedule starting at 11 to 13 months of age or at 15 to 18 months of age was as immunogenic and well tolerated as the administration of 2 doses in children 2 years of age. Immune responses to diphtheria-tetanus-acellular pertussis and H influenzae type b either given alone or coadministered with hepatitis A virus vaccine were similar except for antipertussis toxoid response.

Key Words: hepatitis A vaccine • immunogenicity • safety • children

Abbreviations: HAV—hepatitis A virus • DTaP—diphtheria-tetanus-acellular pertussis • Hib—Haemophilus influenzae type b • GMC—geometric mean concentration • ELU—enzyme-linked immunosorbent assay units • PT—pertussis toxoid • FHA—filamentous hemagglutinin • D—diphtheria toxoid • T—tetanus toxoid • PRP—polyribosylribitol phosphate • AE—adverse event • SAE—serious adverse event • CI—confidence interval

Accepted Feb 15, 2006.