Clinical trial NCT04618939: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Keywords: Diphtheria
Tetanus
Lead sponsor: Boryung Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-06
Enrollment: 218
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The seroprotection rate of anti-diphtheria toxoid (DT) and anti-tetanus toxoid (TT) at 28 days after vaccination with the investigational products
timeFrame: 28 days after vaccination
Secondary outcomes:
measure: The geometric mean titer (GMT) of anti-DT and anti-TT at 28 days after vaccination with the investigational products
timeFrame: 28 days after vaccination
measure: The boosting response for antitoxins of diphtheria and tetanus at 28 days after vaccination with the investigational product
timeFrame: 28 days after vaccination
Other outcomes:
Locations:
city: Changwon
country: Korea, Republic of
facility: Changwon Fatima Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea Daejeon St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji University Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Hanil General Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Paul's Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
Study officials:
affiliation: Saint Vincent's Hospital, Korea
name: Jong Hyun Kim
role: STUDY_CHAIR
References:
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.