Administration of hepatitis A vaccine at 6 and 12 months of age concomitantly with hexavalent (DTaP-IPV-PRP approximately T-HBs) combination vaccine.

Abstract

BACKGROUND:

Administration of two doses of hepatitis A (HA) vaccine to children > or = 2 years of age has been shown to be protective. The present study assessed whether HA vaccine can be administered as early as 6 months of age and whether it can be administered concomitantly with a hexavalent (HV) vaccine at this age.

METHODS:

In an open label, randomized, parallel group study, the liquid HV vaccine (HEXAVAC) (diphtheria, tetanus, 2-component acellular pertussis, inactivated poliomyelitis vaccine, Haemophilus influenzae type b conjugated to tetanus protein and hepatitis B) was administered at 2, 4, 6, and 12 months of age to all children. HA vaccine (VAQTA) was given at 7 and 13 months in the separate administration group (Group 1) and at 6 and 12 months in the concomitant administration group (Group 2). Serum samples were obtained at 2, 7, 12, and 14 months in Group 1 and at 2, 7, 12, and 13 months in Group 2. The primary immunogenicity outcomes were the seroconversion rates for HA 1 month after the second dose of HA vaccine in initially seronegative subjects, and the seroconversion rates for each HV antigen 1 month after the third dose of the HV vaccine (both at 7 months of age).

RESULTS:

HA seropositivity rates 1 month after the second dose were 100% in both groups, regardless of initial serostatus. The responses to each HV antigen 1 month after the third dose were similar in both groups. The vaccines were generally well tolerated in both groups regardless of vaccine(s) administered.

CONCLUSIONS:

A schedule of two doses of HA vaccine, 6 months apart beginning at 6 months of age is highly immunogenic and well tolerated when administered alone or concomitantly with HV vaccine at 6 and 12 months of age.

• Authors: S Stojanov, J G Liese, B H Belohradsky, C Vandermeulen, K Hoppenbrouwers, M Van der Wielen, P Van Damme, B Georges, M Dupuy, M Scemama, M Watson, A Fiquet, J E Stek, G T Golm, F P Schödel, B J Kuter, HEXAVAC/VAQTA Study Group
• Journal: Vaccine (Vaccine) Vol. 25 Issue 43 Pg. 7549-58 (Oct 23 2007) ISSN: 0264-410X [Print] Netherlands
• PMID: 17905486 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Hepatitis A Antibodies
• Hepatitis A Vaccines
• Vaccines, Combined

Topics

• Age Factors
• Child, Preschool
• Female
• Hepatitis A Antibodies (blood)
• Hepatitis A Vaccines (administration & dosage, adverse effects, immunology)
• Humans
• Immunization Schedule
• Infant
• Infant, Newborn
• Male
• Vaccines, Combined (administration & dosage, adverse effects, immunology)