A Phase 2/3 interventional study of LBVD (Hexavalent vaccine) and Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains) in Diphtheria, Tetanus and Pertussis, sponsored by LG Chem. Completed at 1 site in South Korea. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by LG Chem · Phase 2/3, Interventional, and Prevention
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)
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)
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 60 is below the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →LG Chem is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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)
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
Injection within the muscle into the front area of the thigh
Seroprotection/seroconservison/ vaccine-response rate
Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components
Time frame: 4 weeks after three-dose primary series
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
GMC or GMT and their ratio of all types of antibodies
Time frame: 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.
Time frame: 30 minutes after each vaccination
Solicited adverse event
Expected local or systemic side effects after vaccination
Time frame: 7 days after each vaccination
Unsolicited adverse event
All unwanted or bad events after vaccination other than solicited adverse event
Time frame: 28 days after each vaccinations
Ran from Jul 2018 to primary completion in Feb 2019, 7 months.
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vaccines, Combined