Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age

Sponsor
LG Chem
Study ID
NCT06618196
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
50 Days - 70 Days
Healthy Volunteers
Accepted

Interventions

  • LR20062 — BIOLOGICAL
    DTaP-HepB-IPV-Hib vaccine
  • DTaP-HepB-IPV-Hib vaccine — BIOLOGICAL
    Control hexavalent vaccine

Study Details

This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.

Key Dates

Start date
Oct 2, 2024
Status verified
Sep 2024
Primary completion
Jun 30, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
336 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Test group 1
    Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
  • Experimental: Test group 2
    Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
  • Experimental: Test group 3
    High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
  • Active Comparator: Test group 4
    Control hexavalent vaccine (DTaP-HepB-IPV-Hib)

Primary Outcome Measure

Seroprotection/vaccine-response rate [ Time Frame: 1 month after the third dose primary series ]

Central Contacts

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