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
  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:


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 April 21, 2014