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

This study is currently recruiting participants.
Verified August 2012 by Green Cross Corporation
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01402713
First received: July 25, 2011
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Prophylaxis Against Diphtheria, Tetanus
 Biological: GC1107
Biological: SK Td vaccine
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double Blind, Multicenter, Phase II/III Study to Evaluate the Effectiveness(Immunogenecity) and Satety of 'GC1107' Administered Intramuscularly in Healthy Children

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Tetanus
U.S. FDA Resources

Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • seroprotection rate of diphtheria and tetanus [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GMT [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 171
Study Start Date: August 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GC1107-T5.0 Biological: GC1107
GC1107-T5.0: low dose, GC1107-T7.5: high dose
Experimental: GC1107-T7.5 Biological: GC1107
GC1107-T5.0: low dose, GC1107-T7.5: high dose
Active Comparator: Active comparator Biological: SK Td vaccine
SK Td vaccine

  Eligibility

Ages Eligible for Study:   11 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy Korean children(age: 11 ~ 12)
  • who got the basic vaccination(5 times vaccination of diphteria and tetanus until 6 years old.)

Exclusion Criteria:

  • 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 vaccionation
  • who got the vaccination of diphtheria and tetanus within 5 years
  • who has 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
  • who be infected from the diphtheria and tetanus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402713

Contacts
Contact: JinHan Kang, MD 82-2-1588-1511 kjhan@catholic.ac.kr

Locations
Korea, Republic of
The catholic university of Korea, Seoul st. mary's hospital Recruiting
Banpo-dong, Seoul, Korea, Republic of
Contact: JinHan Kang, MD     82-2-1588-1511     kjhan@catholic.ac.kr    
Sponsors and Collaborators
Green Cross Corporation
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01402713     History of Changes
Other Study ID Numbers: GC1107
Study First Received: July 25, 2011
Last Updated: August 29, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diphtheria
Tetanus
Corynebacterium Infections
Actinomycetales Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Clostridium Infections

ClinicalTrials.gov processed this record on May 23, 2013