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

January 23, 2015 updated by: Green Cross Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
311

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Step I-the seroprotection rate of diphtheria and tetanus
Time Frame: 28 days
Number of participants after vaccination as a measure of the effectiveness
28 days
Step II-to assess noninferior of diphtheria and tetanus
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
StepI-GMT of diphtheria and tetanus
Time Frame: 28 days
28 days
Step I-safety assessment-solicited adverse event
Time Frame: 42 days
42 days
Step II-GMT of diphtheria and tetanus
Time Frame: 28 days
28 days
Step II-safety assessment-solicited adverse event
Time Frame: 28 days
28 days
Step II- Boosting response of diphtheria and tetanus
Time Frame: 28
28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Green Cross Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: JinHan Kang, MD, Seol St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GC1107_P2/3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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