A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

Phase 2

Recruiting

• Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type b
• Interventions: Biological: LBVD; Biological: Pentavalent vaccine and Inactivated Polio vaccine

• Registration Number: NCT06947499
• Lead Sponsor: LG Chem

Brief Summary

The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD 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

Detailed Description

Stage 1 (Phase 2)

1. To compare the immunogenicity and safety of LBVD to the licensed Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

Stage 2 (Phase 3)

1. To demonstrate the non-inferior immunogenicity of LBVD to the licensed Control Vaccine at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

2. To demonstrate lot-to-lot consistency in the immunogenicity of three separate lots 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: 2025-04-20
• Study First Submitted QC: 2025-04-20
• Study First Posted: 2025-04-27
• Study Start: 2025-05-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03
• Primary Completion: 2026-11
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1186

Inclusion Criteria

• healthy infants from 6 weeks to 8 weeks of age (both inclusive)
• body weight ≥ 3.2 kg
• born at full term pregnancy (≥ 37 weeks)
• signed informed consent by parent(s) or legally acceptable representative(s)

Exclusion Criteria

• Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis
• Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration
• Known history of SARS-CoV-2 infection
• Participant's mother is HepB antigen or HIV positive
• Fever ≥ 38.0 C/100.4 F within 3 days prior to enrollment
• Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG)
• Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination
• Received immunosuppressive agents or other immune-modifying drugs
• Previous use of blood or blood-derived products
• Any history of allergy (hypersensitivity) to any of the vaccine components
• Participation in another interventional clinical trial within 4 weeks of expected first vaccination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group 1 for Stage 1	LBVD	LBVD
Test group 1 for Stage 2	LBVD	LBVD Lot A
Test group 2 for Stage 2	LBVD	LBVD Lot B
Test group 3 for Stage 2	LBVD	LBVD Lot C
Control group for Stage 1 and Stage 2	Pentavalent vaccine and Inactivated Polio vaccine	Co-administration of Pentavalent vaccine and Inactivated Polio vaccine

Primary Outcome Measures

Name	Time	Method
Seroprotection/seroconversion rate	4 weeks after a three-dose primary series	proportion of participants achieving pre-defined immune response to each antigen
Geometric mean concentration (GMC) for pertussis	4 weeks after a three-dose primary series	GMC for pertussis antigen

Secondary Outcome Measures

Name	Time	Method
Geometric mean titer (GMT) or GMC	4 weeks after the three-dose primary series	GMT or GMC for all antigens
Seroprotection/seroconversion rate	4 weeks after the three-dose primary series	Proportion of participant achieving pre-defined immune response to each antigen
Immediate reactions after vaccination	30 minutes after each vaccination	any signs and symptoms which occur within the first 30 minutes after each vaccination will be monitored
Solicited adverse event	within 7 days after each vaccination	local or systemic signs and symptoms
Unsolicited adverse event	4 weeks after the three-dose primary series	All adverse events other than solicited adverse event

Trial Locations

Locations (1)

Care CT Group; 🇵🇭 Dasmarinas, Cavite, Philippines