DiphtheriaPhase 2NCT04073459
Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants
A Phase 2 study testing DTwP-HepB-Sabin IPV-Hib and Pentavalent vaccine and Salk IPV in people with Diphtheria and Tetanus, run by LG Chem.
Trial summary
The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered… 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?
- DTwP-HepB-Sabin IPV-Hib and Pentavalent vaccine and Salk IPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Aug 2020
- 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 6 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female healthy (i.e. free of obvious health problems) infant who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of first vaccination
- Born at full term pregnancy (Gestational age ≥ 37 weeks)
- Body weight ≥ 3.2 kg at the time of screening
- Received one dose of hepatitis B mono-vaccine within seven days of birth
- Born to both hepatitis B virus surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative mother
- Subject's parent(s) or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
- Written informed consent by subject's parent(s) or LAR
Who cannot join
- Previously received any dose of diphtheria, tetanus, pertussis, polio and/or Hib containing vaccines
- History of previous or concurrent vaccinations other than hepatitis B, Bacillus Calmette-Guerin (BCG), rotavirus and pneumococcal vaccine
- Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases
- Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases
- Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening
- Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening
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- Known or suspected immune disorder or immunodeficient condition
- Receipt of immunoglobulin or blood-derived product since birth
- Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ≥0.5mg/kg/day. Inhaled and topical steroids are allowed.
- History of bleeding disorder contraindicating intramuscular injection
- Major congenital defects or serious chronic illness
- History of any neurological disorders or seizures
- History of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin B, yeast or etc.)
- History of allergic reactions to latex
- Participation in another interventional trial or received any investigational product within 30 days before to the enrollment
- Plan to leave the area of the study site before the end of the study period
- Infants who are considered unsuitable for the clinical study by the investigator
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Randomized, Active-controlled, Parallel-group, Open-label and Phase II Study to Evaluate Immunogenicity and Safety of LBVD (Fully Liquid Hexavalent Vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B- Inactivated Poliomyelitis (Sabin) and Haemophilus Influenzae Type b Conjugate Vaccine) Compared to Co-administration of EupentaTM Inj. and Imovax® Polio (Poliomyelitis Vaccine (Inactivated)) in Separate Injections in Healthy Infants at 6-10-14 Weeks of Age as Primary Series
The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio 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
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type b Infection
- Being tested
- DTwP-HepB-Sabin IPV-Hib, Pentavalent vaccine and Salk IPV
- 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.
DTwP-HepB-Sabin IPV-HibBiological
Intramuscular injection into the anterolateral area of the thigh
Pentavalent vaccine and Salk IPVBiological
Intramuscular injection into anterolateral area of the thigh
| Study group | Role | What they receive |
|---|---|---|
| L dose of Hexavalent | Experimental | Low dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib) Receives: Biological: DTwP-HepB-Sabin IPV-Hib |
| M dose of Hexavalent | Experimental | Middle dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib) Receives: Biological: DTwP-HepB-Sabin IPV-Hib |
| H dose of Hexavalent | Experimental | High dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib). Receives: Biological: DTwP-HepB-Sabin IPV-Hib |
| Pentavalent+IPV | Active comparator | Co-administration of EupentaTM Inj and Imovax Polio Receives: Biological: Pentavalent vaccine and Salk IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroprotection/seroconversion/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 (6)
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
Seroprotection rate against diphtheria with cut-off ≥ 1.0 IU/mL
Proportion of subjects achieving anti-diphtheria toxoid antibody level with cut-off ≥ 1.0 IU/mL
Measured: 4 weeks after three-dose primary series
Seroprotection rate against tetanus with cut-off ≥ 1.0 IU/mL
Proportion of subjects achieving anti-tetanus toxoid antibody level with cut-off ≥ 1.0 IU/mL
Measured: 4 weeks after three-dose primary series
Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL
Proportion of subjects achieving anti-PRP antibody level with cut-off ≥ 1 µg/mL
Measured: 4 weeks after three-dose primary series
Seroconversion rate against Salk serotypes
Proportion of subjects achieving seroconversion of each Salk wild poliovirus serotype
Measured: 4 weeks after three-dose primary series
Seroprotection rate against Sabin and Salk serotypes
Proportion of subjects achieving seroprotection of each Sabin and Salk poliovirus serotype
Measured: 4 weeks after 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 posted29 Aug 2019
- Study startNov 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionAug 2020 (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
- None (open label)
- 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
- NCT04073459
- Sponsor's protocol ID
- LG-VDCL002
- Status last verified
- Sep 2019
- First submitted
- 27 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Active-controlled, Parallel-group, Open-label and Phase II Study to Evaluate Immunogenicity and Safety of LBVD (Fully Liquid Hexavalent Vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B- Inactivated Poliomyelitis (Sabin) and Haemophilus Influenzae Type b Conjugate Vaccine) Compared to Co-administration of EupentaTM Inj. and Imovax® Polio (Poliomyelitis Vaccine (Inactivated)) in Separate Injections in Healthy Infants at 6-10-14 Weeks of Age as Primary Series
- ClinicalTrials.gov ID
- NCT04073459
- Acronym / sponsor ID
- LG-VDCL002
- 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
- Nov 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 29 Aug 2019 (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 the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| L dose of Hexavalent | Experimental | Biological: DTwP-HepB-Sabin IPV-HibLow dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib) |
| M dose of Hexavalent | Experimental | Biological: DTwP-HepB-Sabin IPV-HibMiddle dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib) |
| H dose of Hexavalent | Experimental | Biological: DTwP-HepB-Sabin IPV-HibHigh dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib). |
| Pentavalent+IPV | Active comparator | Biological: Pentavalent vaccine and Salk IPVCo-administration of EupentaTM Inj and Imovax Polio |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- A male or female healthy (i.e. free of obvious health problems) infant who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of first vaccination
- Born at full term pregnancy (Gestational age ≥ 37 weeks)
- Body weight ≥ 3.2 kg at the time of screening
- Received one dose of hepatitis B mono-vaccine within seven days of birth
- Born to both hepatitis B virus surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative mother
Key exclusion criteria (17 listed)
- Previously received any dose of diphtheria, tetanus, pertussis, polio and/or Hib containing vaccines
- History of previous or concurrent vaccinations other than hepatitis B, Bacillus Calmette-Guerin (BCG), rotavirus and pneumococcal vaccine
- Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases
- Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases
- Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening
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 |
|---|---|---|
| DTwP-HepB-Sabin IPV-HibIntramuscular injection into the anterolateral area of the thigh | Biological | H dose of Hexavalent, L dose of Hexavalent, M dose of Hexavalent |
| Pentavalent vaccine and Salk IPVIntramuscular injection into anterolateral area of the thigh | Biological | Pentavalent+IPV |
Primary outcome
seroprotection/seroconversion/vaccine-response rate
Time frame: 4 weeks after three-dose primary series
Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components
6 secondary outcomes
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
Time frame: 4 weeks after three-dose primary series
Seroprotection rate against diphtheria with cut-off ≥ 1.0 IU/mL
Time frame: 4 weeks after three-dose primary series
Seroprotection rate against tetanus with cut-off ≥ 1.0 IU/mL
Time frame: 4 weeks after three-dose primary series
Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL
Time frame: 4 weeks after three-dose primary series
Seroconversion rate against Salk serotypes
Time frame: 4 weeks after three-dose primary series
Seroprotection rate against Sabin and Salk serotypes
Time frame: 4 weeks after three-dose primary series
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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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 DTwP-HepB-Sabin IPV-Hib and Pentavalent vaccine and Salk IPV 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 7 inclusion and 17 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 6 Sep 2019. 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 Yunjeong Yang (+82-2-6987-4158, yangyj@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seroprotection/seroconversion/vaccine-response rate (time frame: 4 weeks after three-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 6 Sep 2019.