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

September 1, 2026 updated by: LG Chem

A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II/III Clinical 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 (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1186

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Cavite
      • Dasmariñas, Cavite, Philippines
        • CARE CT Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group 1 for Stage 1
LBVD
Biological: LBVD
Intramuscular injection into the anterolateral area of the thigh
Experimental: Test group 1 for Stage 2
LBVD Lot A
Biological: LBVD
Intramuscular injection into the anterolateral area of the thigh
Experimental: Test group 2 for Stage 2
LBVD Lot B
Biological: LBVD
Intramuscular injection into the anterolateral area of the thigh
Experimental: Test group 3 for Stage 2
LBVD Lot C
Biological: LBVD
Intramuscular injection into the anterolateral area of the thigh
Active Comparator: Control group for Stage 1 and Stage 2
Co-administration of Pentavalent vaccine and Inactivated Polio vaccine
Biological: Pentavalent vaccine and Inactivated Polio vaccine
Intramuscular injection into the anterolateral area of the thigh

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2025

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 20, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-VDCL004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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