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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age6-8
SponsorLG Chem

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

Treatment groups

1,186 Participants
are divided into 5 treatment groups

Sponsors and collaborators