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

NCT ID: NCT01402713

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-11-30

Brief Summary

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

Detailed Description

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

Conditions

Bacterial Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

GC1107-T5.0

Dosage: 0.5ml

Group Type: EXPERIMENTAL

GC1107

Intervention Type: BIOLOGICAL

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

GC1107-T7.5

Dosage: 0.5ml

Group Type: EXPERIMENTAL

GC1107

Intervention Type: BIOLOGICAL

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

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

Group Type: ACTIVE_COMPARATOR

TD_PUR INJ / SK Td vaccine

Intervention Type: BIOLOGICAL

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

Interventions

GC1107

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

Intervention Type: BIOLOGICAL

TD_PUR INJ / SK Td vaccine

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

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JinHan Kang, MD

Role: PRINCIPAL_INVESTIGATOR

Seol St. Mary's Hospital

Locations

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

Banpo-dong, Seoul, South Korea

Countries

South Korea

Other Identifiers

GC1107_P2/3

Identifier Type: -

Identifier Source: org_study_id