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

Boryung

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Tetanus

Treatments: Biological: Td-pur inj; Biological: BR-TD-1001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04618939

BR-TD-1001-CH-301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 10 to 12 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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218 participants in 2 patient groups

BR-TD-1001

Experimental group

Description:

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

Treatment:

Biological: BR-TD-1001

Td-pur inj

Active Comparator group

Description:

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

Treatment:

Biological: Td-pur inj