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

Tetanus Clinical Trial

Official title:

Double Blind, Randomized Phase III Study to Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618939
• Other study ID #: BR-TD-1001-CH-301
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Diphtheria
• Tetanus

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