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

Sponsor
LG Chem
Study ID
NCT06947499
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Diphtheria
  • Haemophilus Influenzae Type b
  • Hepatitis B
  • Pertussis
  • Poliomyelitis
  • Tetanus

Eligibility Criteria

Sex
ALL
Age
6 Weeks - 8 Weeks
Healthy Volunteers
Accepted

Interventions

  • LBVD — BIOLOGICAL
    Intramuscular injection into the anterolateral area of the thigh
  • Pentavalent vaccine and Inactivated Polio vaccine — BIOLOGICAL
    Intramuscular injection into the anterolateral area of the thigh

Study Details

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

Key Dates

Start date
May 30, 2025
Status verified
Jun 2025
Primary completion
Nov 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
1,186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Test group 1 for Stage 1
    LBVD
  • Experimental: Test group 1 for Stage 2
    LBVD Lot A
  • Experimental: Test group 2 for Stage 2
    LBVD Lot B
  • Experimental: Test group 3 for Stage 2
    LBVD Lot C
  • Active Comparator: Control group for Stage 1 and Stage 2
    Co-administration of Pentavalent vaccine and Inactivated Polio vaccine

Primary Outcome Measure

Seroprotection/seroconversion rate [ Time Frame: 4 weeks after a three-dose primary series ]

Central Contacts

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