Influenza, HumanPhase 3NCT02917304
A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older
A Phase 3 study testing GC3110A vaccine in people with Influenza, Human, run by Green Cross Corporation at 10 sites in South Korea.
Trial summary
The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- GC3110A vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 10 Oct 2016to 8 May 2017
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy adults aged 65 years and older
- Informed consent form has been signed and dated
- Able to comply with the requirements of the study
Who cannot join
- Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components
- Personal history of Guillain-Barre syndrome(GBS)
- Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
- Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
- Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
The Catholic Univ. of Korea Daejeon St.Mary's Hospital
Daejeon
Soon Chun Hyang University Bucheon Hospital
Gyeonggi-do
The Catholic Univ.of Korea Bucheon St.Mary's Hospital
Gyeonggi-do
The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
Gyeonggi-do
EWHA woman's university mokdong hospital
Seoul
KyungHee University Medical Center
Seoul
Soon Chun Hyang University Seoul Hospital
Seoul
The Catholic Univ. of Korea Incheon St.Mary's Hospital
Seoul
The Catholic Univ.of Korea Seoul St.Mary's Hospital
Seoul
The Catholic Univ.of Korea Yeouido St.Mary's Hospital
Seoul
About this study
Official title: A Multicenter, Open-label, Single Arm Study to Evaluate the Immunological Efficacy and Safety of GC3110A. Administered Intramuscularly in Healthy Subjects Aged 65 Years and Older
The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.
Read the detailed description
Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).
- Conditions
- Influenza, Human
- Being tested
- GC3110A vaccine
- Keywords
- Quadrivalent Influenza Vaccines
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC3110A vaccineBiological
Also called GC3110A
0.5mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| GC3110A vaccine group | Experimental | Participants administered a single dose of GC3110A(Quadrivalent Influenza Vaccine). Receives: Biological: GC3110A vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Measured: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
Measured: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Secondary outcomes (1)
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination
Measured: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start10 Oct 2016
- Primary completion2 Dec 2016
- Study completion8 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917304
- Sponsor's protocol ID
- GC3110A_ED_P3
- Status last verified
- May 2017
- First submitted
- 26 Sep 2016
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single Arm Study to Evaluate the Immunological Efficacy and Safety of GC3110A. Administered Intramuscularly in Healthy Subjects Aged 65 Years and Older
- ClinicalTrials.gov ID
- NCT02917304
- Acronym / sponsor ID
- GC3110A_ED_P3
- Conditions
- Influenza, Human
- Keywords
- Quadrivalent Influenza Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 2 Dec 2016 (actual)
- Study completion
- 8 May 2017 (actual)
- First posted
- 28 Sep 2016 (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 immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.
Detailed description
Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC3110A vaccine group | Experimental | Biological: GC3110A vaccineParticipants administered a single dose of GC3110A(Quadrivalent Influenza Vaccine). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Healthy adults aged 65 years and older
- Informed consent form has been signed and dated
- Able to comply with the requirements of the study
Key exclusion criteria (5 listed)
- Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components
- Personal history of Guillain-Barre syndrome(GBS)
- Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
- Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
- Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
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 |
|---|---|---|
| GC3110A vaccineAlso: GC3110A0.5mL, Intramuscular | Biological | GC3110A vaccine group |
Primary outcome
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Time frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
Time frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
1 secondary outcome
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination
Time frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
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 30 May 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GC3110A vaccine in people with Influenza, Human, run by Green Cross Corporation at 10 sites 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 5 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination (time frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)). 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 30 May 2017.