Influenza, HumanPhase 3NCT02915809
A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults
A Phase 3 study testing GC3110B vaccine and GCFLU Quadrivalent Inj. vaccine in people with Influenza, Human, run by Green Cross Corporation.
Trial summary
The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- GC3110B vaccine and GCFLU Quadrivalent Inj. vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 60 years
- 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-Barré syndrome
- 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
About this study
Official title: A Randomized, Double-Blind, Multicenter Study to Compare the Immunological Efficacy and Safety of GC3110B With GCFLU Quadrivalent Inj. Administered Intramuscularly in Healthy Adults
The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.
Read the detailed description
Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.
- Conditions
- Influenza, Human
- Being tested
- GC3110B vaccine, GCFLU Quadrivalent Inj. vaccine
- Keywords
- 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.
GC3110B vaccineBiological
Also called GC3110B
0.5mL, Intramuscular
GCFLU Quadrivalent Inj. vaccineBiological
Also called GCFLU Quadrivalent Inj.
0.5mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| GC3110B Vaccine Group | Experimental | Participants randomized to receive a single dose of GC3110B vaccine (Biological: GC3110B vaccine). Receives: Biological: GC3110B vaccine |
| GCFLU Quadrivalent Inj. | Active comparator | Participants randomized to receive a single dose of GCFLU Quadrivalent Inj. vaccine (Biological: GCFLU Quadrivalent Inj. vaccine). Receives: Biological: GCFLU Quadrivalent Inj. vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj.
Geometric mean titers of antibodies will be assessed using the hemagglutination inhibition (HI) assay.
Measured: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Secondary outcomes (4)
Percentage of Participants Achieving Pre-Defined Seroconversion Before and Following Vaccination
Seroconversion is defined as either a pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1: 40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.
Measured: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Percentage of Participants Achieving Pre-Defined Seroprotection Before and Following Vaccination
Antibodies will be assessed using the hemagglutination inhibition (HI) assay. Seroprotection is defined as a titer ≥1:40 at pre-vaccination and 21 days after vaccination.
Measured: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination
Measured: Day 0 to Day 6
Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination
Measured: Day 0 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2016 (estimated)
- Study completionMay 2017 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915809
- Sponsor's protocol ID
- GC3110B_P3
- Status last verified
- Sep 2016
- First submitted
- 25 Sep 2016
- Last updated
- 29 Sep 2016
- 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 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter Study to Compare the Immunological Efficacy and Safety of GC3110B With GCFLU Quadrivalent Inj. Administered Intramuscularly in Healthy Adults
- ClinicalTrials.gov ID
- NCT02915809
- Acronym / sponsor ID
- GC3110B_P3
- Conditions
- Influenza, Human
- Keywords
- Influenza Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 27 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 GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.
Detailed description
Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.
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 |
|---|---|---|
| GC3110B Vaccine Group | Experimental | Biological: GC3110B vaccineParticipants randomized to receive a single dose of GC3110B vaccine (Biological: GC3110B vaccine). |
| GCFLU Quadrivalent Inj. | Active comparator | Biological: GCFLU Quadrivalent Inj. vaccineParticipants randomized to receive a single dose of GCFLU Quadrivalent Inj. vaccine (Biological: GCFLU Quadrivalent Inj. vaccine). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 18 to 60 years
- 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-Barré syndrome
- 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 |
|---|---|---|
| GC3110B vaccineAlso: GC3110B0.5mL, Intramuscular | Biological | GC3110B Vaccine Group |
| GCFLU Quadrivalent Inj. vaccineAlso: GCFLU Quadrivalent Inj.0.5mL, Intramuscular | Biological | GCFLU Quadrivalent Inj. |
Primary outcome
Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj.
Time frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Geometric mean titers of antibodies will be assessed using the hemagglutination inhibition (HI) assay.
4 secondary outcomes
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 Seroprotection Before and Following Vaccination
Time frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination
Time frame: Day 0 to Day 6
Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination
Time frame: Day 0 to Day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GC3110B vaccine and GCFLU Quadrivalent Inj. vaccine in people with Influenza, Human, run by Green Cross Corporation.
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: status not confirmed, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj. (time frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)). 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 29 Sep 2016.