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

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.

Study Overview

• Status: Completed
• Conditions: Tetanus; Diphtheria
• Intervention / Treatment: Biological: BR-TD-1001; Biological: 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 Type: Interventional
• Enrollment (Actual): 218
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Changwon, Korea, Republic of
    • Changwon Fatima Hospital
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea Daejeon ST. Mary's hospital
  • Incheon, Korea, Republic of
    • The Catholic University of Korea Incheon St. Mary's Hospital
  • Seoul, 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
  • Wonju, Korea, Republic of
    • Yonsei University Wonju Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BR-TD-1001; Randomized subjects were assigned to receive a single dose of BR-TD-1001	Biological: BR-TD-1001; 0.5 mL, IM
Active Comparator: Td-pur inj; Randomized subjects were assigned to receive a single dose of Td-pur inj	Biological: Td-pur inj; 0.5 mL, IM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boryung Biopharma Co., Ltd.
• Investigators: Study Chair: Jong Hyun Kim, Saint Vincent's Hospital, Korea

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2016
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Diphtheria; Tetanus
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Clostridium Infections; Corynebacterium Infections; Tetanus; Diphtheria
• Other Study ID Numbers: BR-TD-1001-CH-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No