Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults

Green Cross Corporation1 site in 1 country376 target enrollmentMay 2014

Overview

The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.

Randomized, double blind, multicenter, phaseⅢ study

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

October 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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

seroprotection rate of diphtheria and tetanus

Time Frame: 28days

GMT (Geometric Mean Titer)(28days)
solicited adverse events(7days)
Boosting response of diphtheria and tetanus compared participants with before and after the injection(28days)
Seroprotection rate according to the respective age group(28days)
GMT according to the respective age group(28days)
unsolicited adverse events(28 days)