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Randomized, Double-blind, Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults
The purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19-64 years of age.
Details
| Lead sponsor | Green Cross Corporation |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 213 |
| Start date | 2019-10-14 |
| Completion | 2021-05 |
Conditions
- Tetanus
- Diphtheria
- Whooping Cough
Interventions
- GC3111 vaccine
- Boostrix® vaccine
Primary outcomes
- Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine — Day 0 (pre-vaccination) to Day 14 (post-vaccination)
- Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine — Day 0 (pre-vaccination) to Day 28 (post-vaccination)
- Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine — Day 0 (pre-vaccination) to Day 180 (post-vaccination)
- Vital Signs — Day 0 (pre-vaccination), Day 28 (post-vaccination)
Blood Pressure (systolic, diastolic) in mmHg - Vital Signs — Day 0 (pre-vaccination), Day 28 (post-vaccination)
Pulse Rate in pulses per minute - Vital Signs — Day 0 (pre-vaccination), Day 28 (post-vaccination)
Body Temperature in degrees Celcius
Countries
South Korea