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

LG Chem

Status and phase: Not yet enrolling; Phase 2

Conditions: Poliomyelitis; Diphtheria; Hepatitis B; Pertussis; Tetanus; Haemophilus Influenzae Type B Infection

Treatments: Biological: LR20062; Biological: DTaP-HepB-IPV-Hib vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06618196

LG-VGCL002

Details and patient eligibility

About

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.

Enrollment: 336 estimated patients

Sex: All

Ages: 50 to 70 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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336 participants in 4 patient groups

Test group 1

Experimental group

Description:

Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)

Treatment:

Biological: LR20062

Test group 2

Experimental group

Description:

Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)

Treatment:

Biological: LR20062

Test group 3

Experimental group

Description:

High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)

Treatment:

Biological: LR20062

Test group 4

Active Comparator group

Description:

Control hexavalent vaccine (DTaP-HepB-IPV-Hib)

Treatment:

Biological: DTaP-HepB-IPV-Hib vaccine