A Ph III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine Quinvaxem (DTwP-Hib-HepB Vaccine) when Administered to Indian Infants at 6, 10, and 14 Weeks of Age

This is a Phase III, single arm, multicentre, open label study to evaluate immunogenicity, safety and tolerability of 3 doses of a pentavalent vaccine administered to Indian infants at approximately 6, 10 and 14 weeks of age. The study will be conducted in 4 centers in India. DTwP-HepB-Hib is a fully liquid vaccine combining Diphtheria, Tetanus, whole cell Bordetella pertussis (B. pertussis), Hepatitis B (HepB), and Haemophilus influenzae type b (Hib) antigens. The primary immunogenicity objective of the study is to assess the seroprotective titers to diphtheria, tetanus, HepB, B.pertussis and  Hib one month after third study injection. Secondary Immunogenicity Objective is to evaluate geometric mean concentration (GMCs) against diphtheria, tetanus, B.pertussis, HepB and Hib antigens one month after third study injection,   The safety objective is to evaluate the safety and tolerability of Quinvaxem vaccine administered to infants at Days 1, 29 and 57 of the study.

7 Feb 2012: Study is not initiated at site 03, No Subjects recruited at this site.