A Phase 2/3 interventional study of LBVD and Pentavalent vaccine and Inactivated Polio vaccine in Diphtheria, Tetanus and Pertussis, sponsored by LG Chem. Active, not recruiting at 1 site in Philippines. 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, 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
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)
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's planned enrollment of 1,186 is above 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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
LBVD
Biological: LBVD
LBVD Lot A
Biological: LBVD
LBVD Lot B
Biological: LBVD
LBVD Lot C
Biological: LBVD
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
Intramuscular injection into the anterolateral area of the thigh
Seroprotection/seroconversion rate
proportion of participants achieving pre-defined immune response to each antigen
Time frame: 4 weeks after a three-dose primary series
Geometric mean concentration (GMC) for pertussis
GMC for pertussis antigen
Time frame: 4 weeks after a three-dose primary series
Geometric mean titer (GMT) or GMC
GMT or GMC for all antigens
Time frame: 4 weeks after the three-dose primary series
Seroprotection/seroconversion rate
Proportion of participant achieving pre-defined immune response to each antigen
Time frame: 4 weeks after the three-dose primary series
Immediate reactions after vaccination
any signs and symptoms which occur within the first 30 minutes after each vaccination will be monitored
Time frame: 30 minutes after each vaccination
Solicited adverse event
local or systemic signs and symptoms
Time frame: within 7 days after each vaccination
Unsolicited adverse event
All adverse events other than solicited adverse event
Time frame: 4 weeks after the three-dose primary series
Started May 2025 (actual). Primary completion is estimated for Feb 2028, 32 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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