To Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children
NCT ID: NCT04618939
Last Updated: 2020-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
218 participants
INTERVENTIONAL
2016-10-20
2017-04-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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BR-TD-1001
Randomized subjects were assigned to receive a single dose of BR-TD-1001
BR-TD-1001
0.5 mL, IM
Td-pur inj
Randomized subjects were assigned to receive a single dose of Td-pur inj
Td-pur inj
0.5 mL, IM
Interventions
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BR-TD-1001
0.5 mL, IM
Td-pur inj
0.5 mL, IM
Eligibility Criteria
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Inclusion Criteria
2. Those who received primary immunization (5 doses of diphtheria and tetanus vaccination until the age of 6)
3. Voluntary written consent of the subject and the legally acceptable representative(LAR) to participate in this clinical study
Exclusion Criteria
2. Temporary thrombocytopenia or neurological complications due to diphtheria or tetanus vaccination
3. History of a severe allergy to any component of the investigational product
4. History of a severe adverse event due to administration of diphtheria, tetanus, or diphtheria tetanus combined vaccine
5. Administration of tetanus, diphtheria, or diphtheria tetanus combined vaccine within 5 years
6. Unable to verify diphtheria and tetanus vaccination completed until the age of 6
7. History of infection with diphtheria or tetanus (if clinically, serologically or microbiologically confirmed)
8. Current chronic disease that impedes implementation or completion of the clinical study
9. Scheduled surgery during the study period
10. Acute fever with a tympanic temperature exceeding 38.0ºC within 72 hours before administration of the investigational vaccine
11. Administration of other vaccines within 28 days before screening
12. Use of immunosuppressants or immune modifying drugs within 3 months before screening
13. 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
14. Use of antipyretics/analgesics/nonsteroidal anti inflammatory drugs within 4 hours before administration of the investigational vaccine
15. Participation in other clinical studies within 28 days before screening
16. Those who were determined by the investigator to be ineligible for other reasons
10 Years
12 Years
ALL
Yes
Sponsors
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Boryung Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jong Hyun Kim
Role: STUDY_CHAIR
Saint Vincent's Hospital, Korea
Locations
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Changwon Fatima Hospital
Changwon, , South Korea
The Catholic University of Korea Daejeon St. Mary's Hospital
Daejeon, , South Korea
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon, , South Korea
Asan Medical Center
Seoul, , South Korea
Eulji University Eulji General Hospital
Seoul, , South Korea
Hanil General Hospital
Seoul, , South Korea
Korea Cancer Center Hospital
Seoul, , South Korea
The Catholic University of Korea St. Paul's Hospital
Seoul, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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References
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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.
Other Identifiers
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BR-TD-1001-CH-301
Identifier Type: -
Identifier Source: org_study_id