A Phase II/III Study Evaluating Immunogenicity, Safety, and Lot Consistency of LBVD Vaccine Compared to Pentavalent and Inactivated Polio Vaccines in Healthy Infants at 6, 10, and 14 Weeks

What this Trial Is About

This research aims to evaluate the immune response, safety, and consistency between different batches of the LBVD vaccine compared to the combined use of Pentavalent and Inactivated Poliomyelitis vaccines in healthy infants aged 6 to 8 weeks. The study is divided into two stages: Stage 1 compares LBVD with licensed control vaccines, and Stage 2 confirms that LBVD is not inferior to control vaccines and assesses consistency across three lots of LBVD. Participants receive a three-dose primary vaccination series at 6, 10, and 14 weeks of age. The LBVD vaccine is administered as an intramuscular injection into the thigh. The control group receives co-administration of Pentavalent and Inactivated Polio vaccines. Stage 1 focuses on initial comparisons, while Stage 2 includes multiple LBVD lots to evaluate lot-to-lot consistency. Throughout the study, infants will be monitored for immune protection levels and antibody concentrations four weeks after completing the vaccination series. Safety is tracked by observing immediate reactions within 30 minutes, solicited side effects within 7 days, and other adverse events within 4 weeks post-vaccination. The study follows infants from 6 weeks through 8 weeks of age, including all vaccine administrations and safety assessments.

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series