Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series

NCT ID: NCT05457946

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1438 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-09-30

Brief Summary

The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)

Detailed Description

Stage 1 (Dose-level Finding;Phase 2)

1. To compare the immunogenicity and safety of three LBVD vaccine candidates, varying at different dose levels, to the Control vaccines at 4 weeks after a three-dose primary series of vaccination and thereby, select an optimal vaccine dose level for Stage 2

Stage 2 (Evaluation of Safety, Immunogenicity, and Lot-to-lot Consistency;Phase 3)

1. To demonstrate the non-inferiority and lot-to-lot consistency in the immunogenicity of three separate lots of LBVD to the Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

2. To demonstrate the safety and immunogenicity of LBVD at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Test group 1

Low dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot A for Stage 2

Group Type: EXPERIMENTAL

LBVD (Hexavalent vaccine)

Intervention Type: BIOLOGICAL

Injection within the muscle into the front area of the thigh

Test group 2

Middle dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot B for Stage 2

Group Type: EXPERIMENTAL

LBVD (Hexavalent vaccine)

Intervention Type: BIOLOGICAL

Injection within the muscle into the front area of the thigh

Test group 3

High dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib)for Stage 1/ selected dose of hexavalent vaccine Lot C for Stage 2

Group Type: EXPERIMENTAL

LBVD (Hexavalent vaccine)

Intervention Type: BIOLOGICAL

Injection within the muscle into the front area of the thigh

Control group

Co-administration of Pentavalent vaccine and Inactivated Polio vaccine for both stages

Group Type: ACTIVE_COMPARATOR

Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)

Intervention Type: BIOLOGICAL

Injection within the muscle into the front area of the thigh

Interventions

LBVD (Hexavalent vaccine)

Injection within the muscle into the front area of the thigh

Intervention Type: BIOLOGICAL

Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)

Injection within the muscle into the front area of the thigh

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Infants in stable health
• Male or female 6 to 8 weeks of age
• Signed informed consent by the infant's parent(s) or legally acceptable representative(s)

Exclusion Criteria

• Known or suspected Hib, HepB, diphtheria, tetanus, pertussis, or poliomyelitis
• Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration
• Known or suspected immunodeficiency
• Previous use of blood or blood-derived products
• Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination
• Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration
• Any history of allergy (hypersensitivity) to any of the vaccine components
• Participation in another interventional clinical trial simultaneously

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edison Alberto, MD

Role: PRINCIPAL_INVESTIGATOR

Health Index Multispecialty Clinic

Josefina Carlos, MD

Role: PRINCIPAL_INVESTIGATOR

UERM Memorial Medical Center

Central Contacts

Study Lead

Role: CONTACT

lgclinical@lgchem.com

+82-2-3777-1114

Other Identifiers

LG-VDCL003

Identifier Type: -

Identifier Source: org_study_id