Details

Autor(en) / Beteiligte

• Stojanov, S
• Liese, J.G
• Belohradsky, B.H
• Vandermeulen, C
• Hoppenbrouwers, K
• Van der Wielen, M
• Van Damme, P
• Georges, B
• Dupuy, M
• Scemama, M
• Watson, M
• Fiquet, A
• Stek, J.E
• Golm, G.T
• Schödel, F.P
• Kuter, B.J

Titel

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

Ist Teil von

• Vaccine, 2007-10, Vol.25 (43), p.7549-7558

Ort / Verlag

Oxford: Elsevier Ltd

Erscheinungsjahr

2007

Quelle

Elsevier ScienceDirect Journals

Beschreibungen/Notizen

• Abstract Background Administration of two doses of hepatitis A (HA) vaccine to children ≥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.