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

Green Cross Corporation

Status and phase: Completed; Phase 3; Phase 2

Conditions: Bacterial Infections

Treatments: Biological: TD_PUR INJ / SK Td vaccine; Biological: GC1107

Study type: Interventional

Funder types: Industry

Identifiers

NCT01402713

GC1107_P2/3

Details and patient eligibility

About

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

Full description

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

Enrollment: 311 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

311 participants in 3 patient groups

GC1107-T5.0

Experimental group

Description:

Dosage: 0.5ml

Treatment:

Biological: GC1107

GC1107-T7.5

Experimental group

Description:

Dosage: 0.5ml

Treatment:

Biological: GC1107

TD_PUR INJ /SK Td vaccine

Active Comparator group

Description:

The name: step 1(phase 2)-SK Td vaccine step 2(phase 3)-TD_PUR INJ Dosage: 0.5ml

Treatment:

Biological: TD_PUR INJ / SK Td vaccine