DiphtheriaPhase 2/3NCT05457946
Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series
A Phase 2/3 study testing LBVD (Hexavalent vaccine) and Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains) in people with Diphtheria and Tetanus, run by LG Chem at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- LBVD (Hexavalent vaccine) and Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jul 2018to 21 Feb 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the detailed description
Stage 1 (Dose-level Finding;Phase 2)
- 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)
- 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
- 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
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type B Infection
- Being tested
- LBVD (Hexavalent vaccine), Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBVD (Hexavalent vaccine)Biological
Injection within the muscle into the front area of the thigh
Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)Biological
Injection within the muscle into the front area of the thigh
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 | Experimental | Low dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot A for Stage 2 Receives: Biological: LBVD (Hexavalent vaccine) |
| Test group 2 | Experimental | Middle dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib) for Stage 1/ selected dose of hexavalent vaccine Lot B for Stage 2 Receives: Biological: LBVD (Hexavalent vaccine) |
| Test group 3 | Experimental | High dose of candidate hexavalent vaccine (DTwPHepB-Sabin IPV-Hib)for Stage 1/ selected dose of hexavalent vaccine Lot C for Stage 2 Receives: Biological: LBVD (Hexavalent vaccine) |
| Control group | Active comparator | Co-administration of Pentavalent vaccine and Inactivated Polio vaccine for both stages Receives: Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection/seroconservison/ vaccine-response rate
Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components
Measured: 4 weeks after three-dose primary series
Secondary outcomes (4)
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
GMC or GMT and their ratio of all types of antibodies
Measured: 4 weeks after three-dose primary series
Immediate reactions after 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.
Measured: 30 minutes after each vaccination
Solicited adverse event
Expected local or systemic side effects after vaccination
Measured: 7 days after each vaccination
Unsolicited adverse event
All unwanted or bad events after vaccination other than solicited adverse event
Measured: 28 days after each vaccinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start18 Jul 2018
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edison Alberto, MD, Principal investigator, Health Index Multispecialty ClinicJosefina Carlos, MD, Principal investigator, UERM Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457946
- Sponsor's protocol ID
- LG-VDCL003
- Status last verified
- Apr 2019
- First submitted
- 11 Jul 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05457946
- Acronym / sponsor ID
- LG-VDCL003
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type B Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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)
- 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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test group 1 | Experimental | Biological: 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 2 | Experimental | Biological: 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 |
| Test group 3 | Experimental | Biological: 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 |
| Control group | Active comparator | Biological: Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)Co-administration of Pentavalent vaccine and Inactivated Polio vaccine for both stages |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBVD (Hexavalent vaccine)Injection within the muscle into the front area of the thigh | Biological | Test group 1, Test group 2, Test group 3 |
| Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)Injection within the muscle into the front area of the thigh | Biological | Control group |
Primary outcome
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 secondary outcomes
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
Time frame: 4 weeks after three-dose primary series
Immediate reactions after vaccination
Time frame: 30 minutes after each vaccination
Solicited adverse event
Time frame: 7 days after each vaccination
Unsolicited adverse event
Time frame: 28 days after each vaccinations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Active, not recruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edison Alberto, MD principal investigator
Health Index Multispecialty Clinic
Josefina Carlos, MD principal investigator
UERM Memorial Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LBVD (Hexavalent vaccine) and Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains) in people with Diphtheria and Tetanus, run by LG Chem at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprotection/seroconservison/ vaccine-response rate (time frame: 4 weeks after three-dose primary series). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.