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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04618939
Other study ID # BR-TD-1001-CH-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 20, 2016
Est. completion date April 28, 2017

Study information

Verified date November 2020
Source Boryung Biopharma Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 218
Est. completion date April 28, 2017
Est. primary completion date April 28, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 12 Years
Eligibility Inclusion Criteria: 1. Healthy boys and girls aged 10 to 12 years 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: 1. 2 weeks have not passed since recovery from an acute disease 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
BR-TD-1001
0.5 mL, IM
Td-pur inj
0.5 mL, IM

Locations

Country Name City State
Korea, Republic of Changwon Fatima Hospital Changwon
Korea, Republic of The Catholic University of Korea Daejeon St. Mary's Hospital Daejeon
Korea, Republic of The Catholic University of Korea Incheon St. Mary's Hospital Incheon
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Eulji University Eulji General Hospital Seoul
Korea, Republic of Hanil General Hospital Seoul
Korea, Republic of Korea Cancer Center Hospital Seoul
Korea, Republic of The Catholic University of Korea St. Paul's Hospital Seoul
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju

Sponsors (1)

Lead Sponsor Collaborator
Boryung Biopharma Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 28 days after vaccination
Secondary The geometric mean titer (GMT) of anti-DT and anti-TT at 28 days after vaccination with the investigational products 28 days after vaccination
Secondary The boosting response for antitoxins of diphtheria and tetanus at 28 days after vaccination with the investigational product 28 days after vaccination
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