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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

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

  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital

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

1 month to 1 month (Child)

Accepts Healthy Volunteers

Yes

Description

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 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprotection/seroconservison/ vaccine-response rate
Time Frame: 4 weeks after three-dose primary series
Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components
4 weeks after three-dose primary series

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
Time Frame: 4 weeks after three-dose primary series
GMC or GMT and their ratio of all types of antibodies
4 weeks after three-dose primary series
Solicited adverse event
Time Frame: 7 days after each vaccination
Expected local or systemic side effects after vaccination
7 days after each vaccination
Unsolicited adverse event
Time Frame: 28 days after each vaccinations
All unwanted or bad events after vaccination other than solicited adverse event
28 days after each vaccinations
Immediate reactions after vaccination
Time Frame: 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.
30 minutes after each vaccination

Collaborators and Investigators

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

Sponsor

LG Chem

Investigators

  • Principal Investigator: Edison Alberto, MD, Health Index Multispecialty Clinic
  • Principal Investigator: Josefina Carlos, MD, UERM Memorial Medical Center

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)

July 18, 2018

Primary Completion (Actual)

February 21, 2019

Study Completion (Actual)

February 21, 2019

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-VDCL003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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