Clinical Trials Directory

Trials / Unknown

UnknownNCT04238975

A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults

Randomized, Double-blind, Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
213 (estimated)
Sponsor
Green Cross Corporation · Industry
Sex
All
Age
19 Years – 64 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults. To evaluate safety of GC3111 in healthy adults.

Conditions

Interventions

TypeNameDescription
BIOLOGICALGC3111 vaccine0.5mL, Intramuscular
BIOLOGICALBoostrix® vaccine0.5mL, Intramuscular

Timeline

Start date
2019-10-14
Primary completion
2021-02-01
Completion
2021-05-01
First posted
2020-01-23
Last updated
2020-01-23

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04238975. Inclusion in this directory is not an endorsement.