| 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
(Affiliation: University Children's Hospital, Ludwig-Maximilians-University, Munich, Germany.)
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| Journal | Vaccine
(Vaccine)
Vol. 25
Issue 43
Pg. 7549-58
(Oct 23 2007)
ISSN: 0264-410X Netherlands |
| PMID | 17905486
(Publication Type: Journal Article, Randomized Controlled Trial)
|
| Chemical References |
- Hepatitis A Antibodies
- Hepatitis A Vaccines
- Vaccines, Combined
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| 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)
|
