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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

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.

South Korea1 site

Seoul National University Hospital
Seoul, 03080

Other trials in South Korea

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 groups in NCT05457946
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.

18 Jul 201821 Feb 2019

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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
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