Bacterial InfectionsPhase 3NCT02361866
To Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults
A Phase 3 study testing GC1107 and Tetanus and Diphtheria(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(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- GC1107 and Tetanus and Diphtheria(Td vaccine)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Oct 2014
- Phase
- Phase 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy Korean adults (age: over 18 years)
- who got the basic vaccination of DTP(Diphtheria, tetanus, pertussis) in the past
- Subjects willing to provide written informed consent and able to comply with the requirements for the study
Who cannot join
- subjects who have already got the additional vaccination of Td within 5 years
- subjects with antitoxin of diphtheria and tetanus ≥1.0 IU/mL (ELISA)
- only applicable in step I
- subjects who have not recovered from the acute disease within 2 weeks
- subjects who have the medical history of allergic disease related to the components of investigational drug
- who got the treatment of blood product and immunoglobulin product within 3 months
Show all 18Show fewer
- females who are pregnant
- females who are breastfeeding
- subjects who are infected from the diphtheria and tetanus
- subjects who have experienced the severe adverse events for the diphtheria and tetanus vaccination
- Subjects who are scheduled to participate in other clinical trial studies during the study
- Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
- Those who take the other medicine that affects this study or are vaccinated other vaccines
- 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 37.4) 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
Incheon St. Mary's Hospital Catholic Univ.
Incheon, Bupyeong 6-dong, Bupyeong-gu,, 1544-9004
About this study
Official title: Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults
The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.
Read the detailed description
Randomized, double blind, multicenter, phaseⅢ study
- Conditions
- Bacterial Infections
- Being tested
- GC1107, Tetanus and Diphtheria(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
0.5 ml, Intramuscular, single dose(day0)
Tetanus and Diphtheria(Td vaccine)Biological
0.5ml, Intramuscular, single dose(day0) only applicable step1
| Study group | Role | What they receive |
|---|---|---|
| GC1107 | Experimental | 0.5ml, intramuscular, a single dosing Receives: Biological: GC1107 |
| Tetanus and Diphtheria(Td vaccine) | Active comparator | 0.5ml, intramuscular, a single dosing Receives: Biological: Tetanus and Diphtheria(Td vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroprotection rate of diphtheria and tetanus
Measured: 28days
Secondary outcomes (6)
GMT (Geometric Mean Titer)
Measured: 28days
Boosting response of diphtheria and tetanus compared participants with before and after the injection
Boosting response is defined as more 4 times increase of the antibody titer after the injection
Measured: 28days
solicited adverse events
Measured: 7days
unsolicited adverse events
Measured: 28 days
Seroprotection rate according to the respective age group
Measured: 28days
GMT according to the respective age group
Measured: 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JungHyeon Choi, MD, Principal investigator, Incheon St. Mary's Hospital Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361866
- Sponsor's protocol ID
- GC1107_AD_P3
- Status last verified
- Feb 2015
- First submitted
- 22 Apr 2014
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee J, Choi JH, Wie SH, Park SH, Choi SM, Lee MS, Kim TH, Lee HJ, Kang JH. A Phase III Study to Evaluate the Immunogenicity and Safety of GC1107 (Adult Tetanus Diphtheria Vaccine) in Healthy Adults. J Korean Med Sci. 2019 Jan 16;34(4):e31. doi: 10.3346/jkms.2019.34.e31. eCollection 2019 Jan 28.
PubMed 30686952
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults
- ClinicalTrials.gov ID
- NCT02361866
- Acronym / sponsor ID
- GC1107_AD_P3
- Conditions
- Bacterial Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Feb 2015 (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(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.
Detailed description
Randomized, double blind, multicenter, phaseⅢ study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC1107 | Experimental | Biological: GC11070.5ml, intramuscular, a single dosing |
| Tetanus and Diphtheria(Td vaccine) | Active comparator | Biological: Tetanus and Diphtheria(Td vaccine)0.5ml, intramuscular, a single dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy Korean adults (age: over 18 years)
- who got the basic vaccination of DTP(Diphtheria, tetanus, pertussis) in the past
- Subjects willing to provide written informed consent and able to comply with the requirements for the study
Key exclusion criteria (18 listed)
- subjects who have already got the additional vaccination of Td within 5 years
- subjects with antitoxin of diphtheria and tetanus ≥1.0 IU/mL (ELISA)
- subjects who have not recovered from the acute disease within 2 weeks
- subjects who have the medical history of allergic disease related to the components of investigational drug
- who got the treatment of blood product and immunoglobulin product within 3 months
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 |
|---|---|---|
| GC11070.5 ml, Intramuscular, single dose(day0) | Biological | GC1107 |
| Tetanus and Diphtheria(Td vaccine)0.5ml, Intramuscular, single dose(day0) only applicable step1 | Biological | Tetanus and Diphtheria(Td vaccine) |
Primary outcome
seroprotection rate of diphtheria and tetanus
Time frame: 28days
6 secondary outcomes
GMT (Geometric Mean Titer)
Time frame: 28days
Boosting response of diphtheria and tetanus compared participants with before and after the injection
Time frame: 28days
solicited adverse events
Time frame: 7days
unsolicited adverse events
Time frame: 28 days
Seroprotection rate according to the respective age group
Time frame: 28days
GMT according to the respective age group
Time frame: 28days
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 12 Feb 2015.
- Derived from this study: PubMed 30686952Lee J, Choi JH, Wie SH, Park SH, Choi SM, Lee MS, Kim TH, Lee HJ, Kang JH. A Phase III Study to Evaluate the Immunogenicity and Safety of GC1107 (Adult Tetanus Diphtheria Vaccine) in Healthy Adults. J Korean Med Sci. 2019 Jan 16;34(4):e31. doi: 10.3346/jkms.2019.34.e31. eCollection 2019 Jan 28.
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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.
JungHyeon Choi, MD principal investigator
Incheon St. Mary's Hospital Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GC1107 and Tetanus and Diphtheria(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 3 inclusion and 18 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 12 Feb 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 phase mean?
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?
seroprotection rate of diphtheria and tetanus (time frame: 28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361866, which also lists 1 linked publication.
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 12 Feb 2015.