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Asian-Oceanian Journal of Pediatrics and Child Health Volume Three December 2004 Number Two Immunogenicity and safety of a Haemophilus influenzae type b conjugate (PRP-T) vaccine combined with or given concomitantly with a DTP whole-cell combination vaccine.
Suganda TANUWIDJAJA, MD1* Alex CHAIRULFATAH, MD1 Anil DUTTA, MD2 Didier LEBOULLEOUX, MD3
* Corresponding author: Hasan Sadikin Hospital, Bandung, West Java, Indonesia Tel: 62 22 77 49 64 Fax: 62 22 21 12 82
Financial support This research was funded by Aventis Pasteur, France
ABSTRACT
Objectives:
To assess the immunogenicity and safety of Haemophilus influenzae type b (Hib) conjugate vaccine (Act-Hib™, Aventis Pasteur) when combined with a diphtheria-tetanus-whole-cell pertussis (DTwP) combination vaccine (DTP Vaccine™, Biofarma) via extemporaneous mixing.
Methods:
326 healthy infants were randomized to one of three vaccine regimens: DTP Vaccine™ extemporaneously mixed with Act-Hib™ (‘combination’ group, n=129); TetrAct-Hib™ (reference vaccine, n=131); and DTP Vaccine™ given at the same time as Act-Hib™, but at separate sites (‘separate sites’ group, n=66). Infants were vaccinated at 2, 3 and 4 months. Serological assessments were done prior to the first dose of vaccine and 28 days after the third dose. Safety and reactogenicity were assessed immediately after each injection and also by the use of parent diary cards.
Results:
All subjects achieved the primary immunogenicity measure of an anti-PRP titre of >=0.15 mcg/mL at four weeks after the third dose. Most infants also achieved the secondary measure of 1 mcg/mL(a surrogate index of long-term protection): 99.2% (95% CI 95.7–100) of the combination group, 96.7% (95% CI 91.9–99.1) of the TetrAct-Hib™ group and 92.1% (95% CI 82.4–97.4) of the separate sites group. Serological responses to pertussis, diphtheria and tetanus antigens were excellent in all study groups. Most subjects experienced an adverse reaction during the first thee days following vaccination: 100% of the combination group, 99.2% of the TetrAct-Hib™ group and 100% of the separate sites group. The high rate of systemic adverse events observed was attributed to the low temperature selected to define fever (axillary temperature >=36.6oC). One serious adverse event occurred that was classed as unrelated to vaccination. Conclusions: This study confirms the immunogenicity and safety of extemporaneously combining Act-Hib™ with the locally manufactured DTP Vaccine™ as a strategy to reduce the number of injections required in the Indonesian paediatric vaccination schedule. Key Words: Haemophilus influenzae type b, combination vaccines, DTwP vaccine, Hib vaccine, paediatric immunization |
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Latest Journal Volume Three December 2004 Number Two
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Updated July 2006 |
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