Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age

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

This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.

Inclusion Criteria:

1. Male and female subjects ≥ 42 days to ≤ 64 days of age.
2. Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements

Exclusion Criteria:

1. Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study.
2. History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
3. History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
4. Administration of parenteral immunoglobulin preparation and/or blood products since birth.