InfluenzaPhase 3NCT02352584
A Multicenter, Double-blind, Parallel Phase III Study
A Phase 3 study testing GC3110A(Quadrivalent), GC Flu(Trivalent) and GC3110A(Trivalent) in people with Influenza, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GC3110A(Quadrivalent), GC Flu(Trivalent) and GC3110A(Trivalent)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,299 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Jul 2015
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Inability in written/verbal communication
- Subjects who have participated in other interventional study within 30 days
- Alcohol or drug abuse within 6 months
- Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
- Disorders in immune function
- History of Guillain-Barré syndrome
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- Disease/medications which are likely to cause any severe bleeding
- Active infection or experience of fever (>38.0 ℃) within 72 hours following vaccination
- Oral temperature >38.0 ℃ at the vaccination day
- Erythema, tattoo, injury at shoulder (vaccination site)
- Hypersensitivity with egg, chicken, or any of the vaccine components, or Neomycin, Gentamicin
- Influenza vaccination within 6months
- Any vaccination within 30 days
- Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products, or anti-cancer chemotherapy or radiation therapy within3 months
- Pregnant or breast-feeding women
- Clinically significant underlying diseases or medical history at investigator's discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine)
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III
Read the detailed description
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine) After Intramuscular Administration in Healthy Subjects
- Conditions
- Influenza
- Being tested
- GC3110A(Quadrivalent), GC Flu(Trivalent), GC3110A(Trivalent)
- Keywords
- QIV, Quadrivalent Influenza Vaccine, Influenza vaccine, Vaccination
- 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(Quadrivalent)Biological
Also called GC3110A
GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1
GC Flu(Trivalent)Biological
Also called GC Flu Pre-filled Syringe Inj.
GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
GC3110A(Trivalent)Biological
Also called GC3110A
GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
| Study group | Role | What they receive |
|---|---|---|
| GC3110A(Quadrivalent) | Experimental | 0.5ml, intramuscular, a single dosing Receives: Biological: GC3110A(Quadrivalent) |
| GC Flu (Trivalent) | Active comparator | 0.5ml,intramuscular,a single dosing Receives: Biological: GC Flu(Trivalent) |
| GC3110A(Trivalent) | Active comparator | 0.5ml,intramuscular,a single dosing Receives: Biological: GC3110A(Trivalent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
GMT (Active comparator) / GMT(Experimental)
Measured: Day 21 post vaccination
Solicited adverse events following vaccination
Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia
Measured: Day0 up to 21 Day post vaccination
Unsolicited adverse events following vaccination
It can be estimated by Toxicity Grading Scale for healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Measured: Day0 up to 21 Day post vaccination
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
Difference of SCR (Experimental and Active comparator)
Measured: Day 21 post vaccination
Secondary outcomes (5)
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
Measured: Day0 up to 21 Day post vaccination
SPR rate of HI(Hemagglutination Inhibition) antibody
Measured: Day 21 post vaccination
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
Measured: Day 21 post vaccination
Abnormalities in physical examination, Vital signs, clinical laboratory tests
Measured: Day 21 post vaccination
SAE
Measured: Day 180 post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- 1,299 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee Jin Su, M.D, Study director, Inha University HospitalChoi Won Seck, M.D, Study director, Korea University Ansan HospitalLee Ja Cob, Study director, Hallym Univ. Medical CenterWoo Heong Jung, Study director, Hallym Univ. Medical CenterWi Sung Heon, Study director, St Vincent's HospitalJeong Suk In, Study director, Chonnam Natinal University HospitalKim Sin Woo, Study director, Kyungpook National University HospitalKim Tae Hyung, Study director, Soon Chun Hyang Univ. Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352584
- Sponsor's protocol ID
- GC3110A_AD_P3
- Status last verified
- Oct 2015
- First submitted
- 13 Jan 2015
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine)
- ClinicalTrials.gov ID
- NCT02352584
- Acronym / sponsor ID
- GC3110A_AD_P3
- Conditions
- Influenza
- Keywords
- QIV, Quadrivalent Influenza Vaccine, Influenza vaccine, Vaccination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,299 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 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.
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III
Detailed description
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine) After Intramuscular Administration in Healthy Subjects
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 |
|---|---|---|
| GC3110A(Quadrivalent) | Experimental | Biological: GC3110A(Quadrivalent)0.5ml, intramuscular, a single dosing |
| GC Flu (Trivalent) | Active comparator | Biological: GC Flu(Trivalent)0.5ml,intramuscular,a single dosing |
| GC3110A(Trivalent) | Active comparator | Biological: GC3110A(Trivalent)0.5ml,intramuscular,a single dosing |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Inability in written/verbal communication
- Subjects who have participated in other interventional study within 30 days
- Alcohol or drug abuse within 6 months
- Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
- Disorders in immune function
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(Quadrivalent)Also: GC3110AGC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1 | Biological | GC3110A(Quadrivalent) |
| GC Flu(Trivalent)Also: GC Flu Pre-filled Syringe Inj.GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1 | Biological | GC Flu (Trivalent) |
| GC3110A(Trivalent)Also: GC3110AGC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1 | Biological | GC3110A(Trivalent) |
Primary outcome
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
Time frame: Day 21 post vaccination
GMT (Active comparator) / GMT(Experimental)
Solicited adverse events following vaccination
Time frame: Day0 up to 21 Day post vaccination
Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia
Unsolicited adverse events following vaccination
Time frame: Day0 up to 21 Day post vaccination
It can be estimated by Toxicity Grading Scale for healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
Time frame: Day 21 post vaccination
Difference of SCR (Experimental and Active comparator)
5 secondary outcomes
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
Time frame: Day0 up to 21 Day post vaccination
SPR rate of HI(Hemagglutination Inhibition) antibody
Time frame: Day 21 post vaccination
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
Time frame: Day 21 post vaccination
Abnormalities in physical examination, Vital signs, clinical laboratory tests
Time frame: Day 21 post vaccination
SAE
Time frame: Day 180 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 20 Oct 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.
Lee Jin Su, M.D study director
Inha University Hospital
Choi Won Seck, M.D study director
Korea University Ansan Hospital
Lee Ja Cob study director
Hallym Univ. Medical Center
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 GC3110A(Quadrivalent), GC Flu(Trivalent) and GC3110A(Trivalent) in people with Influenza, 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 0 inclusion and 16 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 20 Oct 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?
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain (time frame: Day 21 post vaccination). The study lists 4 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 20 Oct 2015.