DiphtheriaPhase 3NCT04618939
To Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children
A Phase 3 study testing BR-TD-1001 and Td-pur inj in people with Diphtheria and Tetanus, run by Boryung Biopharma Co., Ltd. at 9 sites in South Korea.
Trial summary
The purpose of this study is to evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus
- What is being tested?
- BR-TD-1001 and Td-pur inj
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 20 Oct 2016to 28 Apr 2017
- Phase
- Phase 3
- 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy boys and girls aged 10 to 12 years
- Those who received primary immunization (5 doses of diphtheria and tetanus vaccination until the age of 6)
- Voluntary written consent of the subject and the legally acceptable representative(LAR) to participate in this clinical study
Who cannot join
- 2 weeks have not passed since recovery from an acute disease
- Temporary thrombocytopenia or neurological complications due to diphtheria or tetanus vaccination
- History of a severe allergy to any component of the investigational product
- History of a severe adverse event due to administration of diphtheria, tetanus, or diphtheria tetanus combined vaccine
- Administration of tetanus, diphtheria, or diphtheria tetanus combined vaccine within 5 years
- Unable to verify diphtheria and tetanus vaccination completed until the age of 6
Show all 16Show fewer
- History of infection with diphtheria or tetanus (if clinically, serologically or microbiologically confirmed)
- Current chronic disease that impedes implementation or completion of the clinical study
- Scheduled surgery during the study period
- Acute fever with a tympanic temperature exceeding 38.0ºC within 72 hours before administration of the investigational vaccine
- Administration of other vaccines within 28 days before screening
- Use of immunosuppressants or immune modifying drugs within 3 months before screening
- Those who have received immunoglobulin therapies or blood derived products within 3 months before screening, or are expected to receive them during the study period
- Use of antipyretics/analgesics/nonsteroidal anti inflammatory drugs within 4 hours before administration of the investigational vaccine
- Participation in other clinical studies within 28 days before screening
- Those who were determined by the investigator to be ineligible for other reasons
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Changwon Fatima Hospital
Changwon
The Catholic University of Korea Daejeon St. Mary's Hospital
Daejeon
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon
Asan Medical Center
Seoul
Eulji University Eulji General Hospital
Seoul
Hanil General Hospital
Seoul
Korea Cancer Center Hospital
Seoul
The Catholic University of Korea St. Paul's Hospital
Seoul
Yonsei University Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: Double Blind, Randomized Phase III Study to Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children
The purpose of this study is to evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
Read the detailed description
Primary objective:
To evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
Secondary objectives:
- To evaluate immunogenicity by measuring the geometric mean titer (of diphtheria and tetanus antitoxins at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
- To evaluate a boosting response by comparing before and after the administration through measurement of diphtheria and tetanus antitoxin titers at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
- To evaluate safety by observing solicited local and systemic adverse events that have occurred for 7 days after vaccination with BR-TD-1001 and Td-pur-inj.
- To evaluate safety by observing unsolicited adverse events that have occurred for 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
- Conditions
- Diphtheria, Tetanus
- Being tested
- BR-TD-1001, Td-pur inj
- Keywords
- Diphtheria, Tetanus
- Medical subject headings
- Diphtheria, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR-TD-1001Biological
0.5 mL, IM
Td-pur injBiological
0.5 mL, IM
| Study group | Role | What they receive |
|---|---|---|
| BR-TD-1001 | Experimental | Randomized subjects were assigned to receive a single dose of BR-TD-1001 Receives: Biological: BR-TD-1001 |
| Td-pur inj | Active comparator | Randomized subjects were assigned to receive a single dose of Td-pur inj Receives: Biological: Td-pur inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroprotection rate of anti-diphtheria toxoid (DT) and anti-tetanus toxoid (TT) at 28 days after vaccination with the investigational products
Seroprotection was defined as anti-DT and anti-TT antibody concentrations ≥ 0.1 IU/mL (ELISA)
Measured: 28 days after vaccination
Secondary outcomes (2)
The geometric mean titer (GMT) of anti-DT and anti-TT at 28 days after vaccination with the investigational products
Measured: 28 days after vaccination
The boosting response for antitoxins of diphtheria and tetanus at 28 days after vaccination with the investigational product
Measured: 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start20 Oct 2016
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jong Hyun Kim, Study chair, Saint Vincent's Hospital, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618939
- Sponsor's protocol ID
- BR-TD-1001-CH-301
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Choi UY, Kim KH, Lee J, Eun BW, Kim HM, Lee KY, Kim DH, Ma SH, Lee J, Kim JH. Immunogenicity and Safety of a Newly Developed Tetanus-Diphtheria Toxoid (Td) in Healthy Korean Adolescents: a Multi-center, Randomized, Double-blind, Active-Controlled Phase 3 Trial. J Korean Med Sci. 2021 Dec 20;36(49):e313. doi: 10.3346/jkms.2021.36.e313.
PubMed 34931494
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized Phase III Study to Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children
- ClinicalTrials.gov ID
- NCT04618939
- Acronym / sponsor ID
- BR-TD-1001-CH-301
- Conditions
- Diphtheria, Tetanus
- Keywords
- Diphtheria, Tetanus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Boryung Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 6 Nov 2020 (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 by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
Detailed description
Primary objective:
To evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
Secondary objectives:
- To evaluate immunogenicity by measuring the geometric mean titer (of diphtheria and tetanus antitoxins at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
- To evaluate a boosting response by comparing before and after the administration through measurement of diphtheria and tetanus antitoxin titers at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
- To evaluate safety by observing solicited local and systemic adverse events that have occurred for 7 days after vaccination with BR-TD-1001 and Td-pur-inj.
- To evaluate safety by observing unsolicited adverse events that have occurred for 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BR-TD-1001 | Experimental | Biological: BR-TD-1001Randomized subjects were assigned to receive a single dose of BR-TD-1001 |
| Td-pur inj | Active comparator | Biological: Td-pur injRandomized subjects were assigned to receive a single dose of Td-pur inj |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy boys and girls aged 10 to 12 years
- Those who received primary immunization (5 doses of diphtheria and tetanus vaccination until the age of 6)
- Voluntary written consent of the subject and the legally acceptable representative(LAR) to participate in this clinical study
Key exclusion criteria (16 listed)
- 2 weeks have not passed since recovery from an acute disease
- Temporary thrombocytopenia or neurological complications due to diphtheria or tetanus vaccination
- History of a severe allergy to any component of the investigational product
- History of a severe adverse event due to administration of diphtheria, tetanus, or diphtheria tetanus combined vaccine
- Administration of tetanus, diphtheria, or diphtheria tetanus combined vaccine within 5 years
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 |
|---|---|---|
| BR-TD-10010.5 mL, IM | Biological | BR-TD-1001 |
| Td-pur inj0.5 mL, IM | Biological | Td-pur inj |
Primary outcome
The seroprotection rate of anti-diphtheria toxoid (DT) and anti-tetanus toxoid (TT) at 28 days after vaccination with the investigational products
Time frame: 28 days after vaccination
Seroprotection was defined as anti-DT and anti-TT antibody concentrations ≥ 0.1 IU/mL (ELISA)
2 secondary outcomes
The geometric mean titer (GMT) of anti-DT and anti-TT at 28 days after vaccination with the investigational products
Time frame: 28 days after vaccination
The boosting response for antitoxins of diphtheria and tetanus at 28 days after vaccination with the investigational product
Time frame: 28 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 34931494Choi UY, Kim KH, Lee J, Eun BW, Kim HM, Lee KY, Kim DH, Ma SH, Lee J, Kim JH. Immunogenicity and Safety of a Newly Developed Tetanus-Diphtheria Toxoid (Td) in Healthy Korean Adolescents: a Multi-center, Randomized, Double-blind, Active-Controlled Phase 3 Trial. J Korean Med Sci. 2021 Dec 20;36(49):e313. doi: 10.3346/jkms.2021.36.e313.
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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.
Jong Hyun Kim study chair
Saint Vincent's Hospital, Korea
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BR-TD-1001 and Td-pur inj in people with Diphtheria and Tetanus, run by Boryung Biopharma Co., Ltd. at 9 sites in South Korea.
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 3 inclusion and 16 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: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The seroprotection rate of anti-diphtheria toxoid (DT) and anti-tetanus toxoid (TT) at 28 days after vaccination with the investigational products (time frame: 28 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04618939, which also lists 1 linked publication.
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 20 Nov 2020.