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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-70
SponsorLG Chem

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • LR20062
  • DTaP-HepB-IPV-Hib vaccine

Treatment groups

336 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators