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

Phase 2

Not yet recruiting

• Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type B Infection
• Interventions: Biological: LR20062; Biological: DTaP-HepB-IPV-Hib vaccine

• Registration Number: NCT06618196
• Lead Sponsor: LG Chem

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30
• Study Start: 2024-10-02
• Primary Completion: 2025-06-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 336

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group 1	LR20062	Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Test group 2	LR20062	Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Test group 3	LR20062	High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Test group 4	DTaP-HepB-IPV-Hib vaccine	Control hexavalent vaccine (DTaP-HepB-IPV-Hib)

Primary Outcome Measures

Name	Time	Method
Seroprotection/vaccine-response rate	1 month after the third dose primary series	* Proportion of subjects achieving seroprotection to each antigenic components; * Proportion of subjects with vaccine response for pertussis antigens

Secondary Outcome Measures

Name	Time	Method
Geometric mean concentration (GMC) or Geometric mean titer (GMT)	1 month after the third dose primary series	GMC or GMT and their ratio of all types of antibodies
Seroconversion rate	1 month after the third dose primary series	Proportion of subjects achieving seroconversion to pertussis and poliovirus
Long-term seroprotection rate	1 month after the third dose primary series	Proportion of subjects with seroconversion for diphtheria, tetanus, and Hib antigens
Solicited adverse event	7 days after each vaccination	Expected local or systemic side effects after vaccination
Unsolicited adverse event	1 month after each vaccinations	Any AEs other than solicited AEs
Immediate reactions after vaccination	30 minutes after each vaccination	Any AEs that occur within 30 minutes after the study vaccine administration