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

Sponsor

Boryung Biopharma Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04618939

Collaborator

(none)

218

Enrollment

Locations

Arms

6.2

Actual Duration (Months)

24.2

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diphtheria Tetanus	Biological: BR-TD-1001 Biological: Td-pur inj	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

218 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

double-blind

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 20, 2016

Actual Primary Completion Date :

Apr 28, 2017

Actual Study Completion Date :

Apr 28, 2017

Arms and Interventions

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

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

Outcome Measures

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 [28 days after vaccination]
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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country
1	Changwon Fatima Hospital	Changwon	Korea, Republic of
2	The Catholic University of Korea Daejeon St. Mary's Hospital	Daejeon	Korea, Republic of
3	The Catholic University of Korea Incheon St. Mary's Hospital	Incheon	Korea, Republic of
4	Asan Medical Center	Seoul	Korea, Republic of
5	Eulji University Eulji General Hospital	Seoul	Korea, Republic of
6	Hanil General Hospital	Seoul	Korea, Republic of
7	Korea Cancer Center Hospital	Seoul	Korea, Republic of
8	The Catholic University of Korea St. Paul's Hospital	Seoul	Korea, Republic of
9	Yonsei University Wonju Severance Christian Hospital	Wonju	Korea, Republic of

Sponsors and Collaborators

Boryung Biopharma Co., Ltd.

Investigators

Study Chair: Jong Hyun Kim, Saint Vincent's Hospital, Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boryung Biopharma Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04618939

Other Study ID Numbers:

BR-TD-1001-CH-301

First Posted:

Nov 6, 2020

Last Update Posted:

Nov 20, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Boryung Biopharma Co., Ltd.

Diphtheria

Tetanus

Additional relevant MeSH terms:

Tetanus

Diphtheria

Study Results

No Results Posted as of Nov 20, 2020