Randomized, Double Blind, Multicenter, Phase II/III Study to Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children

Green Cross Corporation1 site in 1 country311 target enrollmentAugust 2011

Overview

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

Randomized, double blind, multicenter, phase Ⅱ/Ⅲ study

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

November 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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