Bacterial Infections
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.
Detailed description
Randomized, double blind, multicenter, phaseⅢ study
Interventions
BIOLOGICALGC1107
0.5 ml, Intramuscular, single dose(day0)
BIOLOGICALTetanus and Diphtheria(Td vaccine)
0.5ml, Intramuscular, single dose(day0) only applicable step1
Sponsors
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy Korean adults (age: over 18 years) * who got the basic vaccination of DTP(Diphtheria, tetanus, pertussis) in the past * Subjects willing to provide written informed consent and able to comply with the requirements for the study
Exclusion criteria
* subjects who have already got the additional vaccination of Td within 5 years * subjects with antitoxin of diphtheria and tetanus ≥1.0 IU/mL (ELISA) * only applicable in step I * subjects who have not recovered from the acute disease within 2 weeks * subjects who have the medical history of allergic disease related to the components of investigational drug * who got the treatment of blood product and immunoglobulin product within 3 months * females who are pregnant * females who are breastfeeding * subjects who are infected from the diphtheria and tetanus * subjects who have experienced the severe adverse events for the diphtheria and tetanus vaccination * Subjects who are scheduled to participate in other clinical trial studies during the study * Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study * Those who take the other medicine that affects this study or are vaccinated other vaccines * 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 37.4) 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 |
|---|---|
| seroprotection rate of diphtheria and tetanus | 28days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Boosting response of diphtheria and tetanus compared participants with before and after the injection | 28days | Boosting response is defined as more 4 times increase of the antibody titer after the injection |
| solicited adverse events | 7days | — |
| GMT (Geometric Mean Titer) | 28days | — |
| Seroprotection rate according to the respective age group | 28days | — |
| GMT according to the respective age group | 28days | — |
| unsolicited adverse events | 28 days | — |
Countries
South Korea
Outcome results
None listed