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

A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II/III Clinical 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 (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series

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

Stage 1 (Phase 2)

1. To compare the immunogenicity and safety of LBVD to the licensed Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

Stage 2 (Phase 3)

1. To demonstrate the non-inferior immunogenicity of LBVD to the licensed Control Vaccine at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age
2. To demonstrate lot-to-lot consistency in the immunogenicity of three separate lots of LBVD at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• Fever ≥ 38.0 C/100.4 F within 3 days prior to enrollment
• Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG)
• Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination
• Received immunosuppressive agents or other immune-modifying drugs
• Previous use of blood or blood-derived products
• Any history of allergy (hypersensitivity) to any of the vaccine components
• Participation in another interventional clinical trial within 4 weeks of expected first vaccination