Immunogenicity and safety of an indigenously manufactured reconstituted pentavalent (DTwP-HBV+Hib) vaccine in comparison with a foreign competitor following primary and booster immunization in Indian children

• DOI: 10.4161/hv.7.4.14208
• Publication Date: 2011-07-14T19:58:35Z
• Authors: Hitt J. Sharma; Sangita Yadav; Sanjay K. Lalwani; Subhash V. Kapre; Suresh S. Jadhav; Anita Chakravarty; Sameer S. Parekh; Sonali Palkar; Subodh H. Bhardwaj; Gajanan S. Namjoshi; Vikas Verma
• Keywords: Booster dose; Vaccination schedule; Hepatitis A vaccine; Hepatitis B vaccine; Hepatitis B

Objective: An open label, controlled clinical study was conducted in Indian infants aged 6-14 weeks to compare the immunogenicity and safety of a reconstituted pentavalent vaccine (DTwP-HBV+Hib) Serum Institute India Ltd (SIIL) with TritanrixHB+Hiberix Glaxo Smithkline (GSK). Methods: Eligible were randomized receive three doses / comparator vaccine. The vaccines prior administration, by mixing DTwP-HBV (liquid) Hib (lyophilized) IgG antibody titres assessed ELISA at baseline after one month following 3-dose primary immunization schedule. Safety evaluated each dose. Further, also booster dose same cohort children (aged between 15-24 months). Setting: Tertiary-care hospitals Important outcome measures: Immunogenicity vaccination series vaccination. Results: Post-primary immunization, 100% seroprotection noted for Diphtheria, Tetanus, Hepatitis B PRP-Hib components both groups. For pertussis, response 96.1% SIIL 95.4% GSK group. overall profile as well persistence antibodies against all up time comparable A marked rise concentrations indicated effective priming. safe, tolerated significant increase antigens Conclusion: DTwP-HBV+Hib found be safe immunogenic. This compared licensed is cost-effective alternative incorporating into schedule various countries so control worldwide infections.