To Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children

Phase 3

Completed

• Conditions: Diphtheria; Tetanus

• Registration Number: NCT04618939
• Lead Sponsor: Boryung Biopharma Co., Ltd.

Brief 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.

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 Timeline

• Study Start: 2016-10-20
• Primary Completion: 2017-04-28
• Study Completion: 2017-04-28
• Status Verified: 2020-11
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-06
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The seroprotection rate of anti-diphtheria toxoid (DT) and anti-tetanus toxoid (TT) at 28 days after vaccination with the investigational products	28 days after vaccination	Seroprotection was defined as anti-DT and anti-TT antibody concentrations ≥ 0.1 IU/mL (ELISA)

Secondary Outcome Measures

Name	Time	Method
The geometric mean titer (GMT) of anti-DT and anti-TT at 28 days after vaccination with the investigational products	28 days after vaccination
The boosting response for antitoxins of diphtheria and tetanus at 28 days after vaccination with the investigational product	28 days after vaccination

Trial Locations

Locations (9)

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, Korea, Republic of