Observer-blind, Randomized Study to Assess Safety and Immune Response of Hexavalent Vaccine With Reduced Dose IPV Compared to HEXASIILae in Infants

What this Trial Is About

Researchers are evaluating a new hexavalent vaccine containing diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and a reduced dose of inactivated poliovirus vaccine (IPV) antigens in healthy infants and toddlers. This study compares the immunogenicity and safety of this reduced IPV dose vaccine to the licensed full-dose SIIPL HEXASIILae vaccine. The study aims to support global polio eradication by improving IPV availability and affordability through antigen dose reduction. The study is an observer-blind, randomized, active-controlled, multi-center Phase III trial involving 1,557 infants aged 6 to 8 weeks. Participants will be randomized in a 2:1 ratio to receive either the reduced IPV hexavalent vaccine or the full-dose HEXASIILae vaccine. Both groups will receive a three-dose primary vaccination series at 6, 10, and 14 weeks, followed by a booster between 12 and 24 months of age. The vaccines are given to actively immunize infants against six diseases. Participants will be monitored closely for immune response and safety. Safety and immunogenicity data will be collected up to 28 days after the third vaccination dose. After primary vaccination, infants will be followed every three months from 6 to 21 months of age until they receive the booster dose. A final safety and immunogenicity assessment will be done 28 days after the booster. The study will measure the vaccine's ability to produce an immune response without significant adverse effects over the study period ending in May 2026.

Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV