Bacterial InfectionsPhase 2/3NCT01402713
To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children
A Phase 2/3 study testing GC1107 and TD_PUR INJ / SK Td vaccine in people with Bacterial Infections, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- GC1107 and TD_PUR INJ / SK Td vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Nov 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
The catholic university of Korea, Seoul st. mary's hospital
Banpo-dong, Seoul
About this study
Official title: Randomized, Double Blind, Multicenter, Phase II/III Study to Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children
The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children
Read the detailed description
Randomized, double blind, multicenter, phase Ⅱ/Ⅲ study
- Conditions
- Bacterial Infections
- Being tested
- GC1107, TD_PUR INJ / SK Td vaccine
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC1107Biological
GC1107-T5.0: low dose, GC1107-T7.5: high dose
TD_PUR INJ / SK Td vaccineBiological
step 1(phase 2)-TD_PUR INJ step 2(phase 3)-SK Td vaccine
| Study group | Role | What they receive |
|---|---|---|
| GC1107-T5.0 | Experimental | Dosage: 0.5ml Receives: Biological: GC1107 |
| GC1107-T7.5 | Experimental | Dosage: 0.5ml Receives: 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 Receives: Biological: TD_PUR INJ / SK Td vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step I-the seroprotection rate of diphtheria and tetanus
Number of participants after vaccination as a measure of the effectiveness
Measured: 28 days
Step II-to assess noninferior of diphtheria and tetanus
Measured: 28 Days
Secondary outcomes (5)
StepI-GMT of diphtheria and tetanus
Measured: 28 days
Step I-safety assessment-solicited adverse event
Measured: 42 days
Step II-GMT of diphtheria and tetanus
Measured: 28 days
Step II-safety assessment-solicited adverse event
Measured: 28 days
Step II- Boosting response of diphtheria and tetanus
Measured: 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JinHan Kang, MD, Principal investigator, Seol St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402713
- Sponsor's protocol ID
- GC1107_P2/3
- Status last verified
- Jan 2015
- First submitted
- 25 Jul 2011
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Multicenter, Phase II/III Study to Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children
- ClinicalTrials.gov ID
- NCT01402713
- Acronym / sponsor ID
- GC1107_P2/3
- Conditions
- Bacterial Infections
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GC1107-T5.0 | Experimental | Biological: GC1107Dosage: 0.5ml |
| GC1107-T7.5 | Experimental | Biological: GC1107Dosage: 0.5ml |
| TD_PUR INJ /SK Td vaccine | Active comparator | Biological: TD_PUR INJ / SK Td vaccineThe name: step 1(phase 2)-SK Td vaccine step 2(phase 3)-TD_PUR INJ Dosage: 0.5ml |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- healthy Korean children(age: 10 ~ 17)
- 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
Key exclusion criteria (19 listed)
- Subjects with antitoxin of diphtheria and tetanus ≥1.0IU/mL (ELISA)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC1107GC1107-T5.0: low dose, GC1107-T7.5: high dose | Biological | GC1107-T5.0, GC1107-T7.5 |
| TD_PUR INJ / SK Td vaccinestep 1(phase 2)-TD_PUR INJ step 2(phase 3)-SK Td vaccine | Biological | TD_PUR INJ /SK Td vaccine |
Primary outcome
Step I-the seroprotection rate of diphtheria and tetanus
Time frame: 28 days
Number of participants after vaccination as a measure of the effectiveness
Step II-to assess noninferior of diphtheria and tetanus
Time frame: 28 Days
5 secondary outcomes
StepI-GMT of diphtheria and tetanus
Time frame: 28 days
Step I-safety assessment-solicited adverse event
Time frame: 42 days
Step II-GMT of diphtheria and tetanus
Time frame: 28 days
Step II-safety assessment-solicited adverse event
Time frame: 28 days
Step II- Boosting response of diphtheria and tetanus
Time frame: 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JinHan Kang, MD principal investigator
Seol St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GC1107 and TD_PUR INJ / SK Td vaccine in people with Bacterial Infections, run by Green Cross Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step I-the seroprotection rate of diphtheria and tetanus (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.