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
1 other identifier
interventional
218
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2016
Shorter than P25 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2017
CompletedFirst Submitted
Initial submission to the registry
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 6, 2020
CompletedNovember 20, 2020
November 1, 2020
6 months
November 2, 2020
November 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
BR-TD-1001
EXPERIMENTALRandomized subjects were assigned to receive a single dose of BR-TD-1001
Td-pur inj
ACTIVE COMPARATORRandomized subjects were assigned to receive a single dose of Td-pur inj
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Changwon Fatima Hospital
Changwon, South Korea
The Catholic University of Korea Daejeon St. Mary's Hospital
Daejeon, South Korea
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon, South Korea
Asan Medical Center
Seoul, South Korea
Eulji University Eulji General Hospital
Seoul, South Korea
Hanil General Hospital
Seoul, South Korea
Korea Cancer Center Hospital
Seoul, South Korea
The Catholic University of Korea St. Paul's Hospital
Seoul, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, South Korea
Related Publications (1)
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.
PMID: 34931494DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jong Hyun Kim
Saint Vincent's Hospital, Korea
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double-blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2020
First Posted
November 6, 2020
Study Start
October 20, 2016
Primary Completion
April 28, 2017
Study Completion
April 28, 2017
Last Updated
November 20, 2020
Record last verified: 2020-11