Safety and immunogenicity of diphtheria-tetanus-pertussis vaccine and hepatitis B vaccine as a new tetravalent combination (DTwP/HB) administered alone and at separate sites (DTwP and HB) including comparison with standard commercially available combination vaccine in Indian infants 6-14 weeks of age.

ABSTRACT

An open, comparative study was conducted at two tertiary care hospitals in India to assess immunogenicity and reactogenicity following administration of the DTwP/HB combination vaccine (Q-Vac) alone and DTwP and HB (Genevac B) vaccines at separate sites. These vaccines manufactured by Serum Institute of India, Ltd. (SIIL), Pune were compared with DTwP/HB vaccine (Tritanrix HB) manufactured by GlaxoSmithKline (GSK) in infants aged 6-14 weeks. The sample size comprised 447 infants who received DTwP/HB vaccine (Group A-150, SIIL) or DTwP and HB (Group B-147, SIIL) vaccines at separate sites or DTPw/HB vaccine (Group C-150, GSK), in a dose of 0.5 ml intra-muscularly. Pre and postvaccination IgG antibodies were determined by ELISA. Postvaccination, in Group A seroprotection was 99.3%, 100%, 96% and 100% to Diphtheria, Tetanus, Pertussis and HBs components respectively. In Group B (n = 147) it was 98.6%, 100%, 95.9% and 99.3% and in Group C (n = 150), it was 96%, 99.3%, 93.3% and 98.6% to D, T, P and HBs component of the vaccine. Postvaccination, geometric mean titres for each component were comparable across three groups by analysis of variance (ANOVA). Adverse events observed were within the range quoted in literature and no Serious Adverse Event (SAE) was observed. Reactogenicity profile in all three groups was comparable. Q-Vac vaccine manufactured by SIIL was found to be safe and immunogenic. Hepatitis B (HB) component did not interfere with the immune response to DTwP components of the vaccine.