Bacterial Infections
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children
Detailed description
Randomized, double blind, multicenter, phase Ⅱ/Ⅲ study
Interventions
BIOLOGICALGC1107
GC1107-T5.0: low dose, GC1107-T7.5: high dose
BIOLOGICALTD_PUR INJ / SK Td vaccine
step 1(phase 2)-TD\_PUR INJ step 2(phase 3)-SK Td vaccine
Sponsors
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy Korean children(age: 10 \ 17) * In the case of step1 (for step 1) 11\ 12 years * who got the basic vaccination(5 times vaccination of diphtheria and tetanus until 6 years old.) * Subjects willing to provide written informed consent and able to comply with the requirements for the study or informed consent was obtained from the subject's legal guardian
Exclusion criteria
* Subjects with antitoxin of diphtheria and tetanus ≥1.0IU/mL (ELISA) * only applicable in step 1 * subjects who have not recovered from the acute disease within 2 weeks * who has experienced the temporary platelet decrease or has the medical history of neurologic complication * who has the medical history of allergic disease related to the components of investigational drug * who has experienced the severe adverse events for the diphtheria and tetanus vaccination * who got the vaccination of diphtheria and tetanus within 5 years * who has not recovered from the acute disease within 2 weeks * who got the treatment of blood product within 3 months * who got the immunoglobulin should have the wash-out period * who be infected from the diphtheria and tetanus * Subjects who are scheduled to participate in other clinical trial studies during the study. * Current participation in a clinical study involving any other drugs including vaccine within 4 weeks of enrollment of the study vaccine. * Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study * Subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment * Subjects with a history of chronic disease obstacles to the study. * Subjects who have episode of acute febrile (at least 37.5) after injection of vaccine during the study * Subject who have plan of operation during the study. * Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Step I-the seroprotection rate of diphtheria and tetanus | 28 days | Number of participants after vaccination as a measure of the effectiveness |
| Step II-to assess noninferior of diphtheria and tetanus | 28 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Step II-GMT of diphtheria and tetanus | 28 days |
| StepI-GMT of diphtheria and tetanus | 28 days |
| Step II- Boosting response of diphtheria and tetanus | 28 |
| Step II-safety assessment-solicited adverse event | 28 days |
| Step I-safety assessment-solicited adverse event | 42 days |
Countries
South Korea
Outcome results
None listed