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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diphtheria, Tetanus

Intervention / Treatment
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* Biological: BR-TD-1001
* Biological: Td-pur inj


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BR-TD-1001<br>Randomized subjects were assigned to receive a single dose of BR-TD-1001 | Biological: BR-TD-1001<br>* 0.5 mL, IM<br>|
| Active Comparator: Td-pur inj<br>Randomized subjects were assigned to receive a single dose of Td-pur inj | Biological: Td-pur inj<br>* 0.5 mL, IM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diphtheria, Tetanus