DiphtheriaPhase 2NCT06618196
Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age
A Phase 2 study testing LR20062 and DTaP-HepB-IPV-Hib vaccine in people with Diphtheria and Tetanus, run by LG Chem.
Trial summary
This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age. Read more about this study
- Who is it for?
- Ages 50 to 70 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- LR20062 and DTaP-HepB-IPV-Hib vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2024to 30 Apr 2026
- Phase
- Phase 2
- 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 50 to 70 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.
- Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.
Who cannot join
- Medical conditions:
- Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.
- Has a known SARS-CoV-2 infection at Screening.
- Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.
- Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.
- Had a recent febrile illness, defined as axillary temperature ≥38.0℃ [≥100.4℉] occurring at or within 72 hours prior to receipt of study vaccine.
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- Prior/concomitant therapy:
- Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and/or Hib infections since birth.
- Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.
- Meets one or more of the following systemic corticosteroid exclusion criteria:
- Has received systemic corticosteroids (equivalent of ≥0.5 mg/kg total daily dose of prednisone) for ≥14 consecutive days and has not completed treatment at least 30 days prior to Screening.
- Is expected to require any systemic corticosteroids during conduct of the study.
- Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.
- Has received any non-study vaccine within 30 days before the first dose of study vaccine or is scheduled to receive any other vaccine within one month after the third dose of study vaccine.
- Exception: Vaccines against BCG and Hep B at birth, rotavirus, MMR, and PCV if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II, Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Immunogenicity and Safety of DTaP-HepB-IPV-Hib Hexavalent Vaccine LR20062 Versus Hexaxim Administered Intramuscularly in Healthy Infants As Primary Series At 2, 4, 6 Months of Age
This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type B Infection
- Being tested
- LR20062, DTaP-HepB-IPV-Hib vaccine
- 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.
LR20062Biological
DTaP-HepB-IPV-Hib vaccine
DTaP-HepB-IPV-Hib vaccineBiological
Control hexavalent vaccine
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 | Experimental | Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib) Receives: Biological: LR20062 |
| Test group 2 | Experimental | Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib) Receives: Biological: LR20062 |
| Test group 3 | Experimental | High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib) Receives: Biological: LR20062 |
| Test group 4 | Active comparator | Control hexavalent vaccine (DTaP-HepB-IPV-Hib) Receives: Biological: DTaP-HepB-IPV-Hib vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection/vaccine-response rate
- Proportion of subjects achieving seroprotection to each antigenic components
- Proportion of subjects with vaccine response for pertussis antigens
Measured: 1 month after the third dose primary series
Secondary outcomes (6)
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
GMC or GMT and their ratio of all types of antibodies
Measured: 1 month after the third dose primary series
Seroconversion rate
Proportion of subjects achieving seroconversion to pertussis and poliovirus
Measured: 1 month after the third dose primary series
Long-term seroprotection rate
Proportion of subjects with seroconversion for diphtheria, tetanus, and Hib antigens
Measured: 1 month after the third dose primary series
Solicited adverse event
Expected local or systemic side effects after vaccination
Measured: 7 days after each vaccination
Unsolicited adverse event
Any AEs other than solicited AEs
Measured: 1 month after each vaccinations
Immediate reactions after vaccination
Any AEs that occur within 30 minutes after the study vaccine administration
Measured: 30 minutes after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start2 Oct 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Apr 2026 (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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 336 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
- NCT06618196
- Sponsor's protocol ID
- LG-VGCL002
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Immunogenicity and Safety of DTaP-HepB-IPV-Hib Hexavalent Vaccine LR20062 Versus Hexaxim Administered Intramuscularly in Healthy Infants As Primary Series At 2, 4, 6 Months of Age
- ClinicalTrials.gov ID
- NCT06618196
- Acronym / sponsor ID
- LG-VGCL002
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type B Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test group 1 | Experimental | Biological: LR20062Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib) |
| Test group 2 | Experimental | Biological: LR20062Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib) |
| Test group 3 | Experimental | Biological: LR20062High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib) |
| Test group 4 | Active comparator | Biological: DTaP-HepB-IPV-Hib vaccineControl hexavalent vaccine (DTaP-HepB-IPV-Hib) |
Who may qualify
- Ages
- 50 to 70 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.
- Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.
Key exclusion criteria (15 listed)
- Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.
- Has a known SARS-CoV-2 infection at Screening.
- Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.
- Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.
- Had a recent febrile illness, defined as axillary temperature ≥38.0℃ [≥100.4℉] occurring at or within 72 hours prior to receipt of study vaccine.
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 |
|---|---|---|
| LR20062DTaP-HepB-IPV-Hib vaccine | Biological | Test group 1, Test group 2, Test group 3 |
| DTaP-HepB-IPV-Hib vaccineControl hexavalent vaccine | Biological | Test group 4 |
Primary outcome
Seroprotection/vaccine-response rate
Time frame: 1 month after the third dose primary series
* Proportion of subjects achieving seroprotection to each antigenic components * Proportion of subjects with vaccine response for pertussis antigens
6 secondary outcomes
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
Time frame: 1 month after the third dose primary series
Seroconversion rate
Time frame: 1 month after the third dose primary series
Long-term seroprotection rate
Time frame: 1 month after the third dose primary series
Solicited adverse event
Time frame: 7 days after each vaccination
Unsolicited adverse event
Time frame: 1 month after each vaccinations
Immediate reactions after vaccination
Time frame: 30 minutes after each vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LR20062 and DTaP-HepB-IPV-Hib vaccine in people with Diphtheria and Tetanus, run by LG Chem.
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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Study Lead (82-2-6987-4427, lgclinical@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprotection/vaccine-response rate (time frame: 1 month after the third 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 1 Oct 2024.