A Multicenter, Prospective, Open-Label, Non-Comparative Study to Evaluate the Immunogenicity and Tolerance of a New, Fully Liquid Pentavalent Vaccine (DTwP-HepB-Hib Vaccine)

Abstract

The current study was planned to assess the immunogenicity and reactogenicity of a fully liquid pentavalent combination vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type B and hepatitis B vaccines. Infants 6-8 weeks of age were enrolled and administered the study vaccine at 0, 4 and 8 weeks of enrollment. The children were kept under observation for 30 minutes after each vaccination for local and systemic reactions. A record was maintained of suspected Adverse Drug Reactions (ADRs) for the subsequent 3 days. Blood was collected for antibody titer estimations prior to the first dose and 4-6 weeks after the 3rd dose. 100% of children developed protective antibody titres to D, T and HepB. 97% and 81% of vaccinees responded (2-4 fold rise in antibody titres) to the anti-fimbrial and anti-pertactin components of the pertussis antigen respectively. 100% infants developed short-term protective antibody titres to Hib (> 0.15 μg/ml) and 90% developed titres indicative of long-term protection (> 1.00 μg/ml). Fever was most commonly reported adverse event but none of the children had fever more than 102°F. A few infants had mild, expected local and systemic side effects such as tenderness, erythema, induration, excessive fussiness and a change in feeding pattern. Except for one child who was withdrawn from the study for persistent crying, there were no other severe or unexpected adverse reactions reported.

† Presented partially at the 12th ASEAN Pediatric Federation Conference, Thailand. 25-28 Nov. 2004.