About this trial
The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants
Eligibility criteria
Qualifiers
healthy infants from 6 weeks to 8 weeks of age (both inclusive)
body weight ≥ 3.2 kg
born at full term pregnancy (≥ 37 weeks)
signed informed consent by parent(s) or legally acceptable representative(s)
Disqualifiers
Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis
Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration
Known history of SARS-CoV-2 infection
Participant's mother is HepB antigen or HIV positive
Trial design
Treatments tested in this trial
- LBVD
- Pentavalent vaccine and Inactivated Polio vaccine