search
Back to results

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

Primary Purpose

Diphtheria, Tetanus

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BR-TD-1001
Td-pur inj
Sponsored by
Boryung Biopharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus

Eligibility Criteria

10 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Changwon Fatima Hospital
  • The Catholic University of Korea Daejeon St. Mary's Hospital
  • The Catholic University of Korea Incheon St. Mary's Hospital
  • Asan Medical Center
  • Eulji University Eulji General Hospital
  • Hanil General Hospital
  • Korea Cancer Center Hospital
  • The Catholic University of Korea St. Paul's Hospital
  • Yonsei University Wonju Severance Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BR-TD-1001

Td-pur inj

Arm Description

Randomized subjects were assigned to receive a single dose of BR-TD-1001

Randomized subjects were assigned to receive a single dose of Td-pur inj

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
November 2, 2020
Last Updated
November 18, 2020
Sponsor
Boryung Biopharma Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04618939
Brief Title
To Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children
Official Title
Double Blind, Randomized Phase III Study to Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 20, 2016 (Actual)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
April 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus
Keywords
Diphtheria, Tetanus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BR-TD-1001
Arm Type
Experimental
Arm Description
Randomized subjects were assigned to receive a single dose of BR-TD-1001
Arm Title
Td-pur inj
Arm Type
Active Comparator
Arm Description
Randomized subjects were assigned to receive a single dose of Td-pur inj
Intervention Type
Biological
Intervention Name(s)
BR-TD-1001
Intervention Description
0.5 mL, IM
Intervention Type
Biological
Intervention Name(s)
Td-pur inj
Intervention Description
0.5 mL, IM
Primary Outcome Measure Information:
Title
The seroprotection rate of anti-diphtheria toxoid (DT) and anti-tetanus toxoid (TT) at 28 days after vaccination with the investigational products
Description
Seroprotection was defined as anti-DT and anti-TT antibody concentrations ≥ 0.1 IU/mL (ELISA)
Time Frame
28 days after vaccination
Secondary Outcome Measure Information:
Title
The geometric mean titer (GMT) of anti-DT and anti-TT at 28 days after vaccination with the investigational products
Time Frame
28 days after vaccination
Title
The boosting response for antitoxins of diphtheria and tetanus at 28 days after vaccination with the investigational product
Time Frame
28 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy boys and girls aged 10 to 12 years Those who received primary immunization (5 doses of diphtheria and tetanus vaccination until the age of 6) Voluntary written consent of the subject and the legally acceptable representative(LAR) to participate in this clinical study Exclusion Criteria: 2 weeks have not passed since recovery from an acute disease Temporary thrombocytopenia or neurological complications due to diphtheria or tetanus vaccination History of a severe allergy to any component of the investigational product History of a severe adverse event due to administration of diphtheria, tetanus, or diphtheria tetanus combined vaccine Administration of tetanus, diphtheria, or diphtheria tetanus combined vaccine within 5 years Unable to verify diphtheria and tetanus vaccination completed until the age of 6 History of infection with diphtheria or tetanus (if clinically, serologically or microbiologically confirmed) Current chronic disease that impedes implementation or completion of the clinical study Scheduled surgery during the study period Acute fever with a tympanic temperature exceeding 38.0ºC within 72 hours before administration of the investigational vaccine Administration of other vaccines within 28 days before screening Use of immunosuppressants or immune modifying drugs within 3 months before screening 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 Use of antipyretics/analgesics/nonsteroidal anti inflammatory drugs within 4 hours before administration of the investigational vaccine Participation in other clinical studies within 28 days before screening Those who were determined by the investigator to be ineligible for other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Hyun Kim
Organizational Affiliation
Saint Vincent's Hospital, Korea
Official's Role
Study Chair
Facility Information:
Facility Name
Changwon Fatima Hospital
City
Changwon
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Daejeon St. Mary's Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Incheon St. Mary's Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Eulji University Eulji General Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hanil General Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Paul's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34931494
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs