Clinical Trial

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

Recruiting Phase 2/3
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-20; most recent amendment 2025-06-30.
Status change: Not Yet Recruiting → Recruiting 2025-06-30
Trial Details
NCT Number NCT06947499
Lead Sponsor LG Chem
Conditions Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type b
Enrollment 1,186 participants
Start Date 2025-05-30
Primary Completion 2026-11 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2025-07-03