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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

StatusActive, Not Recruiting
PhasePhase 2/3
SponsorLG Chem
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Nov 2026 → Feb 28, 2028
See other at-risk trials from LG Chem

Record History

  1. Primary completion pushed from Nov 2026 to Feb 28, 2028
    • Enrollment closed, study ongoing
    • Study completion pushed from Apr 2027 to Dec 31, 2028
    • Site details revised
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2025 to May 30, 2025
    • Site details revised
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
LG Chem
13 trials monitored
See 1 trial at risk
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
Trial Details
NCT Number NCT06947499
Lead Sponsor LG Chem
Conditions
(from sponsor)		 Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type b
Related terms Diphtheria, Haemophilus Infections, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough
Enrollment 1,186 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov