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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
218
0.5 mL, IM
0.5 mL, IM
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
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)
Time frame: 28 days after vaccination
The geometric mean titer (GMT) of anti-DT and anti-TT at 28 days after vaccination with the investigational products
Time frame: 28 days after vaccination
The boosting response for antitoxins of diphtheria and tetanus at 28 days after vaccination with the investigational product
Time frame: 28 days after vaccination
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Yonsei University Wonju Severance Christian Hospital
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