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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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