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

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

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Biological: GC1107; Biological: TD_PUR INJ / SK Td vaccine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 311
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Banpo-dong, Seoul, Korea, Republic of
      • The Catholic University of Korea, Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step I-the seroprotection rate of diphtheria and tetanus	Number of participants after vaccination as a measure of the effectiveness	28 days
Step II-to assess noninferior of diphtheria and tetanus		28 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
StepI-GMT of diphtheria and tetanus	28 days
Step I-safety assessment-solicited adverse event	42 days
Step II-GMT of diphtheria and tetanus	28 days
Step II-safety assessment-solicited adverse event	28 days
Step II- Boosting response of diphtheria and tetanus	28

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Principal Investigator: JinHan Kang, MD, Seol St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (Estimate): July 26, 2011

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 23, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: GC1107_P2/3