NCT01402713

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

2.3 years

First QC Date

July 25, 2011

Last Update Submit

January 23, 2015

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

Study Arms (3)

GC1107-T5.0

EXPERIMENTAL

Dosage: 0.5ml

Biological: GC1107

GC1107-T7.5

EXPERIMENTAL

Dosage: 0.5ml

Biological: GC1107

TD_PUR INJ /SK Td vaccine

ACTIVE COMPARATOR

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

Interventions

GC1107BIOLOGICAL

GC1107-T5.0: low dose, GC1107-T7.5: high dose

GC1107-T5.0GC1107-T7.5
TD_PUR INJ / SK Td vaccineBIOLOGICAL

step 1(phase 2)-TD\_PUR INJ step 2(phase 3)-SK Td vaccine

TD_PUR INJ /SK Td vaccine

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The catholic university of Korea, Seoul st. mary's hospital

Banpo-dong, Seoul, South Korea

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • JinHan Kang, MD

    Seol St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

KR(1)