InfluenzaPhase 1/2NCT02249221
Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)
A Phase 1/2 study testing Quadrivalent cell-culture based influenza vaccin and Trivalent influenza vaccine in people with Influenza, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of GC3106 after single intramuscular administration in Korean healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Quadrivalent cell-culture based influenza vaccin and Trivalent influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Nov 2014
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Given written informed consent
- Healthy Korean adults (age: between over 19 and under 65)
- Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures
- Those who are able to comply with the requirements for the study
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
- Heavy drinkers or subjects who do not agree to stop drinking for 3 days before vaccination and other 3 days after vaccination
- Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
- Hypersensitivity with drug or active ingredient
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- Disorders in immune function
- History of Guillain-Barré syndrome
- 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)
- 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 Randomized (Part B), Open-label (Part A) or Double-blind (Part B), Active-controlled (Part B) Phase I/IIa Study to Investigate the Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of GC3106 after single intramuscular administration in Korean healthy adults.
Read the detailed description
This study is the first in human trial of GC3106 and is designed as an adaptive Phase I/IIa to ensure participants protection. Part A is an open-label and single arm study in 9 healthy volunteers. Data and Safety Monitoring Board (DSMB) will review the solicited/unsolicited adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days after vaccination from the first 9 healthy volunteers. Part B is a randomized (2:1), double-blind, active controlled study and a total of 75 volunteers will participate in this part. Adverse events assessment will be done according to the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'.
- Conditions
- Influenza
- Being tested
- Quadrivalent cell-culture based influenza vaccin, Trivalent influenza vaccine
- Keywords
- Influenza vaccine, Vaccination, cell-culture based influenza vaccine, cell culture derived influenza vaccine, CCIV
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent cell-culture based influenza vaccinBiological
Also called GC3106
GC3106, 0.5ml, intramuscular, a single dosing at Day 1
Trivalent influenza vaccineBiological
Also called GC Flu Pre-filled Syringe Inj.
GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
| Study group | Role | What they receive |
|---|---|---|
| Quadrivalent cell-culture based influenza vaccin | Experimental | Day 1: GC3106, 0.5ml, intramuscular, a single dosing Receives: Biological: Quadrivalent cell-culture based influenza vaccin |
| Trivalent influenza vaccine | Active comparator | Day 1: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing Receives: Biological: Trivalent influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Day 1 up to 7 Days 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: Day 1 up to 22 Days post vaccination
Abnormalities in physical examination, vital signs, and/or clinical laboratory tests
Measured: Day 22 post vaccination
Secondary outcomes (3)
Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain
Measured: Day 22 post vaccination
Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain
Measured: Day 22 post vaccination
GMT(geometric mean titers) for each strain
Measured: Day 22 post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionNov 2014
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woo Joo KIM, M.D., Ph.D, Principal investigator, Korea University Guro HospitalChang-Hee LEE, M.D., Study director, Green Cross Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249221
- Sponsor's protocol ID
- GC3106_P1/2a
- Status last verified
- Dec 2014
- First submitted
- 23 Sep 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized (Part B), Open-label (Part A) or Double-blind (Part B), Active-controlled (Part B) Phase I/IIa Study to Investigate the Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)
- ClinicalTrials.gov ID
- NCT02249221
- Acronym / sponsor ID
- GC3106_P1/2a
- Conditions
- Influenza
- Keywords
- Influenza vaccine, Vaccination, cell-culture based influenza vaccine, cell culture derived influenza vaccine, CCIV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 Sep 2014 (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 safety, tolerability, and immunogenicity of GC3106 after single intramuscular administration in Korean healthy adults.
Detailed description
This study is the first in human trial of GC3106 and is designed as an adaptive Phase I/IIa to ensure participants protection. Part A is an open-label and single arm study in 9 healthy volunteers. Data and Safety Monitoring Board (DSMB) will review the solicited/unsolicited adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days after vaccination from the first 9 healthy volunteers. Part B is a randomized (2:1), double-blind, active controlled study and a total of 75 volunteers will participate in this part. Adverse events assessment will be done according to the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadrivalent cell-culture based influenza vaccin | Experimental | Biological: Quadrivalent cell-culture based influenza vaccinDay 1: GC3106, 0.5ml, intramuscular, a single dosing |
| Trivalent influenza vaccine | Active comparator | Biological: Trivalent influenza vaccineDay 1: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Given written informed consent
- Healthy Korean adults (age: between over 19 and under 65)
- Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures
- Those who are able to comply with the requirements for the study
Key exclusion criteria (17 listed)
- Inability in written/verbal communication
- Subjects who have participated in other interventional study within 30 days
- Alcohol or drug abuse within 6 months
- Heavy drinkers or subjects who do not agree to stop drinking for 3 days before vaccination and other 3 days after vaccination
- Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
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 |
|---|---|---|
| Quadrivalent cell-culture based influenza vaccinAlso: GC3106GC3106, 0.5ml, intramuscular, a single dosing at Day 1 | Biological | Quadrivalent cell-culture based influenza vaccin |
| Trivalent influenza vaccineAlso: GC Flu Pre-filled Syringe Inj.GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1 | Biological | Trivalent influenza vaccine |
Primary outcome
Solicited adverse events following vaccination
Time frame: Day 1 up to 7 Days 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: Day 1 up to 22 Days post vaccination
It can be estimated by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Abnormalities in physical examination, vital signs, and/or clinical laboratory tests
Time frame: Day 22 post vaccination
3 secondary outcomes
Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain
Time frame: Day 22 post vaccination
Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain
Time frame: Day 22 post vaccination
GMT(geometric mean titers) for each strain
Time frame: Day 22 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 5 Dec 2014.
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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.
Woo Joo KIM, M.D., Ph.D principal investigator
Korea University Guro Hospital
Chang-Hee LEE, M.D. study director
Green Cross Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Quadrivalent cell-culture based influenza vaccin and Trivalent influenza vaccine 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 4 inclusion and 17 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 5 Dec 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Solicited adverse events following vaccination (time frame: Day 1 up to 7 Days post vaccination). The study lists 3 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 5 Dec 2014.