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

Launched by LG CHEM · Sep 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new vaccine called LR20062, which is designed to protect infants from several serious infections, including diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib). The study will involve healthy infants who are between 2 to 6 months old, and it aims to see how well the vaccine works and how safe it is when given in three doses at 2, 4, and 6 months of age.

To be part of this trial, infants need to be between 50 to 70 days old and should have been born full-term and healthy. However, some infants may not be eligible if they have had certain infections, recent illnesses, or specific medical conditions. Participants will receive the vaccine and will be monitored for any side effects or reactions. This trial is still in the planning stage and has not started recruiting participants yet, but it is an important step in ensuring that new vaccines are safe and effective for our youngest population.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.
• • 2. Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.
• Exclusion Criteria:
• Medical conditions:
• • 1. Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.
• • 2. Has a known SARS-CoV-2 infection at Screening.
• • 3. Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.
• • 4. Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.
• • 5. 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.
• Prior/concomitant therapy:
• • 6. Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and/or Hib infections since birth.
• • 7. Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.
• 8. Meets one or more of the following systemic corticosteroid exclusion criteria:
• • 1. Has received systemic corticosteroids (equivalent of ≥0.5 mg/kg total daily dose of prednisone) for ≥14 consecutive days and has not completed treatment at least 30 days prior to Screening.
• • 2. Is expected to require any systemic corticosteroids during conduct of the study.
• • Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.
• • 9. Has received any non-study vaccine within 30 days before the first dose of study vaccine or is scheduled to receive any other vaccine within one month after the third dose of study vaccine.
• • Exception: Vaccines against BCG and Hep B at birth, rotavirus, MMR, and PCV if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.