DiphtheriaPhase 2/3NCT06947499
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
A Phase 2/3 study testing LBVD and Pentavalent vaccine and Inactivated Polio vaccine in people with Diphtheria and Tetanus, run by LG Chem at 1 site in Philippines.
Trial summary
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… 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 and Pentavalent vaccine and Inactivated Polio vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,186 participants
- Where
- 1 sitePhilippines
- Study dates
- 30 May 2025to 31 Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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
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 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
Read the detailed description
Stage 1 (Phase 2)
- 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)
- 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
- 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
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type b
- Being tested
- LBVD, Pentavalent vaccine and Inactivated Polio vaccine
- Keywords
- vaccination
- 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.
LBVDBiological
Intramuscular injection into the anterolateral area of the thigh
Pentavalent vaccine and Inactivated Polio vaccineBiological
Intramuscular injection into the anterolateral area of the thigh
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 for Stage 1 | Experimental | LBVD Receives: Biological: LBVD |
| Test group 1 for Stage 2 | Experimental | LBVD Lot A Receives: Biological: LBVD |
| Test group 2 for Stage 2 | Experimental | LBVD Lot B Receives: Biological: LBVD |
| Test group 3 for Stage 2 | Experimental | LBVD Lot C Receives: Biological: LBVD |
| Control group for Stage 1 and Stage 2 | Active comparator | Co-administration of Pentavalent vaccine and Inactivated Polio vaccine Receives: Biological: Pentavalent vaccine and Inactivated Polio vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection/seroconversion rate
proportion of participants achieving pre-defined immune response to each antigen
Measured: 4 weeks after a three-dose primary series
Geometric mean concentration (GMC) for pertussis
GMC for pertussis antigen
Measured: 4 weeks after a three-dose primary series
Secondary outcomes (5)
Geometric mean titer (GMT) or GMC
GMT or GMC for all antigens
Measured: 4 weeks after the three-dose primary series
Seroprotection/seroconversion rate
Proportion of participant achieving pre-defined immune response to each antigen
Measured: 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
Measured: 30 minutes after each vaccination
Solicited adverse event
local or systemic signs and symptoms
Measured: within 7 days after each vaccination
Unsolicited adverse event
All adverse events other than solicited adverse event
Measured: 4 weeks after the three-dose primary series
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start30 May 2025
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- 1,186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947499
- Sponsor's protocol ID
- LG-VDCL004
- Status last verified
- Sep 2026
- First submitted
- 20 Apr 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 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
- ClinicalTrials.gov ID
- NCT06947499
- Acronym / sponsor ID
- LG-VDCL004
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type b
- Keywords
- vaccination
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,186 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 30 May 2025 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Apr 2025 (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, 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
Detailed description
Stage 1 (Phase 2)
- 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)
- 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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Test group 1 for Stage 1 | Experimental | Biological: LBVDLBVD |
| Test group 1 for Stage 2 | Experimental | Biological: LBVDLBVD Lot A |
| Test group 2 for Stage 2 | Experimental | Biological: LBVDLBVD Lot B |
| Test group 3 for Stage 2 | Experimental | Biological: LBVDLBVD Lot C |
| Control group for Stage 1 and Stage 2 | Active comparator | Biological: Pentavalent vaccine and Inactivated Polio vaccineCo-administration of Pentavalent vaccine and Inactivated Polio vaccine |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| LBVDIntramuscular injection into the anterolateral area of the thigh | Biological | Test group 1 for Stage 1, Test group 1 for Stage 2, Test group 2 for Stage 2, Test group 3 for Stage 2 |
| Pentavalent vaccine and Inactivated Polio vaccineIntramuscular injection into the anterolateral area of the thigh | Biological | Control group for Stage 1 and Stage 2 |
Primary outcome
Seroprotection/seroconversion rate
Time frame: 4 weeks after a three-dose primary series
proportion of participants achieving pre-defined immune response to each antigen
Geometric mean concentration (GMC) for pertussis
Time frame: 4 weeks after a three-dose primary series
GMC for pertussis antigen
5 secondary outcomes
Geometric mean titer (GMT) or GMC
Time frame: 4 weeks after the three-dose primary series
Seroprotection/seroconversion rate
Time frame: 4 weeks after the three-dose primary series
Immediate reactions after vaccination
Time frame: 30 minutes after each vaccination
Solicited adverse event
Time frame: within 7 days after each vaccination
Unsolicited adverse event
Time frame: 4 weeks after the three-dose primary series
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Pentavalent vaccine and Inactivated Polio vaccine in people with Diphtheria and Tetanus, run by LG Chem at 1 site in Philippines.
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 4 inclusion and 11 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: under way, not looking for participants, 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 Philippines. 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?
This study is still under way. Results are not available in the source record yet.
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/seroconversion rate (time frame: 4 weeks after a three-dose primary series). The study lists 2 primary outcomes in all. 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.