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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01402713
First received: July 25, 2011
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Bacterial Infections
Biological: GC1107
Biological: TD_PUR INJ / 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(Immunogenicity) and Safety 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 of diphtheria and tetanus [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Boosting response of diphtheria and tetanus [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • safety assessment-solicited adverse event [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • safety assessment-unsolicited adverse event [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • safety assessment [ Time Frame: V/S , Physical examination ] [ Designated as safety issue: Yes ]

Enrollment: 311
Study Start Date: August 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GC1107-T5.0
Dosage: 0.5ml
Biological: GC1107
GC1107-T5.0: low dose, GC1107-T7.5: high dose
Experimental: GC1107-T7.5
Dosage: 0.5ml
Biological: GC1107
GC1107-T5.0: low dose, GC1107-T7.5: high dose
Active Comparator: TD_PUR INJ /SK Td vaccine
The name: step 1(phase 2)-SK Td vaccine step 2(phase 3)-TD_PUR INJ Dosage: 0.5ml
Biological: TD_PUR INJ / SK Td vaccine
step 1(phase 2)-TD_PUR INJ step 2(phase 3)-SK Td vaccine

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • who be infected from the diphtheria and tetanus
  • Subjects who are scheduled to participate in other clinical trial studies during the study.
  • Current participation in a clinical study involving any other drugs including vaccine within 4 weeks of enrollment of the study vaccine.
  • Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
  • Subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment
  • Subjects with a history of chronic disease obstacles to the study.
  • Subjects who have episode of acute febrile (at least 37.5) after injection of vaccine during the study
  • Subject who have plan of operation during the study.
  • Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402713

Locations
Korea, Republic of
The catholic university of Korea, Seoul st. mary's hospital
Banpo-dong, Seoul, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
Investigators
Principal Investigator: JinHan Kang, MD Seol St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01402713     History of Changes
Other Study ID Numbers: GC1107_P2/3
Study First Received: July 25, 2011
Last Updated: April 22, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on November 20, 2014