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Clinical Trial Pediatrics. 2006 Sep;118(3):e602-9. doi: 10.1542/peds.2005-2755.

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 1 , Henry Bernstein, Mark M Blatter, Kenneth Bromberg, Fernando Guerra,
William Kennedy, Michael Pichichero, Shelly D Senders, Andrew Trofa, Alix Collard,
Diane C Sullivan, Dominique Descamps

Affiliations
PMID: 16950952 DOI: 10.1542/peds.2005-2755

Abstract
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($ ) 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.

*$ &+,- .)In this open, comparative, multicenter study, 1084 healthy children aged 11 to 25
months were allocated (4b4b3b3b4 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.

/$ .01
&.) 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.

2, 3 %10. '
, 3)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.

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