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

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.

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