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

Summary

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

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

Conditions7

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