Not Yet RecruitingPhase 2

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

336 participantsStarted 2024-10-02

Plain-language summary

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.

Who can participate

Age range50 Days – 70 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.
✓. Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.

Exclusion criteria

✕. Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.
✕. Has a known SARS-CoV-2 infection at Screening.
✕. Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.
✕. Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.
✕. Had a recent febrile illness, defined as axillary temperature ≥38.0℃ \[≥100.4℉\] occurring at or within 72 hours prior to receipt of study vaccine.
✕. Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and/or Hib infections since birth.
✕. Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.
✕. Meets one or more of the following systemic corticosteroid exclusion criteria:

What they're measuring

Seroprotection/vaccine-response rate

Timeframe: 1 month after the third dose primary series

Trial details

NCT IDNCT06618196

SponsorLG Chem

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-30

Contact for this trial

Clinical Study Lead

82-2-6987-4427 lgclinical@lgchem.com

View on ClinicalTrials.gov More Diphtheria trials