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

NCT01402713 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2015-01-26

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • JinHan Kang, MD · Seol St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01402713 on ClinicalTrials.gov