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

Phase 2

Completed

• Conditions: Bacterial Infections
• Interventions: Biological: GC1107; Biological: TD_PUR INJ / SK Td vaccine

• Registration Number: NCT01402713
• Lead Sponsor: Green Cross Corporation

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

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Start: 2011-08
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GC1107-T5.0	GC1107	Dosage: 0.5ml
GC1107-T7.5	GC1107	Dosage: 0.5ml
TD_PUR INJ /SK Td vaccine	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
StepI-GMT of diphtheria and tetanus	28 days
Step I-safety assessment-solicited adverse event	42 days

Trial Locations

Locations (1)

The catholic university of Korea, Seoul st. mary's hospital; 🇰🇷 Banpo-dong, Seoul, Korea, Republic of