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

Phase 2

Not yet recruiting

• Conditions: Pertussis; Hepatitis B; Tetanus; Haemophilus Influenzae Type B Infection; Diphtheria; Poliomyelitis
• Interventions: Biological: LBVD (Hexavalent vaccine); Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)

• Registration Number: NCT05457946
• Lead Sponsor: LG Chem

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

Study Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10
• Study Start: 2023-04-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1438

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group 2	LBVD (Hexavalent vaccine)	Middle dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot B for Stage 2
Control group	Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)	Co-administration of Pentavalent vaccine and Inactivated Polio vaccine for both stages
Test group 1	LBVD (Hexavalent vaccine)	Low dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot A for Stage 2
Test group 3	LBVD (Hexavalent vaccine)	High dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib)for Stage 1/ selected dose of hexavalent vaccine Lot C for Stage 2

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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. It is collected as an adverse event, but is classified as an immediate reaction only if the AE occurs within 30 minutes after vaccination.
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