Clinical trial NCT01402713: To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children
Official title: Randomized, Double Blind, Multicenter, Phase II/III Study to Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bacterial Infections
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2011-07-26
Enrollment: 311
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Step I-the seroprotection rate of diphtheria and tetanus
timeFrame: 28 days
measure: Step II-to assess noninferior of diphtheria and tetanus
timeFrame: 28 Days
Secondary outcomes:
measure: StepI-GMT of diphtheria and tetanus
timeFrame: 28 days
measure: Step I-safety assessment-solicited adverse event
timeFrame: 42 days
measure: Step II-GMT of diphtheria and tetanus
timeFrame: 28 days
measure: Step II-safety assessment-solicited adverse event
timeFrame: 28 days
measure: Step II- Boosting response of diphtheria and tetanus
timeFrame: 28
Other outcomes:
Locations:
city: Banpo-dong
country: Korea, Republic of
facility: The catholic university of Korea, Seoul st. mary's hospital
state: Seoul
Study officials:
affiliation: Seol St. Mary's Hospital
name: JinHan Kang, MD
role: PRINCIPAL_INVESTIGATOR
References: