The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children
Randomized, double blind, multicenter, phase Ⅱ/Ⅲ study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
311
GC1107-T5.0: low dose, GC1107-T7.5: high dose
step 1(phase 2)-TD\_PUR INJ step 2(phase 3)-SK Td vaccine
The catholic university of Korea, Seoul st. mary's hospital
Banpo-dong, Seoul, South Korea
Step I-the seroprotection rate of diphtheria and tetanus
Number of participants after vaccination as a measure of the effectiveness
Time frame: 28 days
Step II-to assess noninferior of diphtheria and tetanus
Time frame: 28 Days
StepI-GMT of diphtheria and tetanus
Time frame: 28 days
Step I-safety assessment-solicited adverse event
Time frame: 42 days
Step II-GMT of diphtheria and tetanus
Time frame: 28 days
Step II-safety assessment-solicited adverse event
Time frame: 28 days
Step II- Boosting response of diphtheria and tetanus
Time frame: 28
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