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

LG Chem

Status and phase: Not yet enrolling; Phase 3; Phase 2

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

Treatments: Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains); Biological: LBVD (Hexavalent vaccine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05457946

LG-VDCL003

Details and patient eligibility

About

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)

Full 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

Enrollment: 1,438 estimated patients

Sex: All

Ages: 6 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,438 participants in 4 patient groups

Test group 1

Experimental group

Description:

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

Treatment:

Biological: LBVD (Hexavalent vaccine)

Test group 2

Experimental group

Description:

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

Treatment:

Biological: LBVD (Hexavalent vaccine)

Test group 3

Experimental group

Description:

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

Treatment:

Biological: LBVD (Hexavalent vaccine)

Control group

Active Comparator group

Description:

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

Treatment:

Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)