Study to Evaluate the Immunogenicity and Safety of LBVD (Hexavalent Vaccine; DTwP-HepB-IPV-Hib Vaccine), Given to Healthy Infants at Primary Series

Sponsor

LG Chem (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05457946

Collaborator

(none)

1,438

Enrollment

Arms

31.9

Anticipated Duration (Months)

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis Haemophilus Influenzae Type B Infection	Biological: LBVD (Hexavalent vaccine) Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)	Phase 2/Phase 3

Detailed Description

Stage 1 (Dose-level Finding;Phase 2)

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)

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
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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1438 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active-controlled, Parallel-group, Operationally Seamless Phase 2/3 Clinical Study to Evaluate the Immunogenicity and Safety of LBVD, a Fully Liquid Hexavalent Diphtheria-Tetanus-Whole Cell Pertussis-Hepatitis B-poliomyelitis (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Given to Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Biological: LBVD (Hexavalent vaccine) Injection within the muscle into the front area of the thigh
Experimental: 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	Biological: LBVD (Hexavalent vaccine) Injection within the muscle into the front area of the thigh
Experimental: 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	Biological: LBVD (Hexavalent vaccine) Injection within the muscle into the front area of the thigh
Active Comparator: Control group Co-administration of Pentavalent vaccine and Inactivated Polio vaccine for both stages	Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains) Injection within the muscle into the front area of the thigh

Outcome Measures

Primary Outcome Measures

Seroprotection/seroconservison/ vaccine-response rate [4 weeks after three-dose primary series]
Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components

Secondary Outcome Measures

Geometric mean concentration (GMC) or Geometric mean titer (GMT) [4 weeks after three-dose primary series]
GMC or GMT and their ratio of all types of antibodies
Immediate reactions after vaccination [30 minutes after each vaccination]
Immediate reactions after vaccination including all the signs and symptoms that occur within 30 minutes after the vaccination will be monitored at site.
Solicited adverse event [7 days after each vaccination]
Expected local or systemic side effects after vaccination
Unsolicited adverse event [28 days after each vaccinations]
All unwanted or bad events after vaccination other than solicited adverse event

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Weeks to 8 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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