NCT01402713

To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
BIOLOGICAL	GC1107	GC1107-T5.0: low dose, GC1107-T7.5: high dose
BIOLOGICAL	TD_PUR INJ / SK Td vaccine	step 1(phase 2)-TD\_PUR INJ step 2(phase 3)-SK Td vaccine

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-07-26
• Last updated: 2015-01-26

Locations

1 site across 1 country: South Korea