InfluenzaPhase 3NCT03718468
A Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine
A Phase 3 study testing GC FLU Quadrivalent and Fluarix Tetra in people with Influenza, run by Medigen Vaccine Biologics Corp. at 4 sites in Taiwan.
Trial summary
This study aims to demonstrate the immunogenic efficacy of GC FLU Quadrivalent Pre-filled Syringe inj. (GC FLU), a quadrivalent influenza virus vaccine, is non-inferior to the active control, Fluarix Tetra. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GC FLU Quadrivalent and Fluarix Tetra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 842 participants
- Where
- 4 sitesTaiwan
- Study dates
- 30 Oct 2018to 3 Jul 2019
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Either gender, aged 20 to 50 years old (inclusive)
- Willing and able to comply with all the required study visits and follow-up defined by this protocol
- Female subject with childbearing potential or male subject with female spouse/partner with childbearing potential must agree to use highly effective contraceptives from 15 days prior to vaccination until 60 days after vaccination. At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Who cannot join
- With previous known or potential exposure to influenza virus within 12 weeks prior to vaccination
- Received seasonal influenza vaccine (registered or investigational) within 24 weeks prior to vaccination
- Received any vaccine other than seasonal influenza vaccine within 6 weeks prior to vaccination
- Received other investigational products (including medications and vaccines) within 6 weeks prior to vaccination
- Administered immunoglobulins and/or other blood products within the 12 weeks prior to vaccination
- Known or suspected hypersensitivity to any component of vaccines (including egg proteins); or history of allergy to consumption of eggs
Show all 12Show fewer
- History of inflammatory or degenerative neurological disease (e.g., Guillain-Barre syndrome)
- With confirmed or suspected immunosuppressive or immunodeficient condition (e.g. HIV infection), or received > 14 days of systemic steroid with equivalent dosage equal or over to 0.5 mg/kg/day prednisolone or other immune-modifying agents within 24 weeks prior to vaccination
- Positive in HIV, HBsAg, or HCV test
- With fever (defined as body temperature equal or over to 38 °C by any method) on the day of vaccination
- With ongoing acute diseases or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject
- Female subject who is lactating or has positive serum or urine pregnancy test at screening or vaccination
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
National Taiwan University Hospital
Taipei
Taipei Municipal Wan Fang Hospital
Taipei
Tri-Service General Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan
About this study
Official title: A Phase III, Prospective, Randomized, Open-Labeled, Active-Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine, GC FLU, in Adults Aged 20 to 50
This study aims to demonstrate the immunogenic efficacy of GC FLU Quadrivalent Pre-filled Syringe inj. (GC FLU), a quadrivalent influenza virus vaccine, is non-inferior to the active control, Fluarix Tetra. This study is designed to be a randomized, open-labelled, active-controlled, parallel, phase III study recruiting subjects from multiple study sites.
Approximately 840 eligible subjects are planned to enroll in order to obtain 800 evaluable (= per-protocol) subjects. Subjects will be randomized and assigned to GC FLU or Fluarix Tetra (active control, AC) group in 1:1 ratio.
- Conditions
- Influenza
- Being tested
- GC FLU Quadrivalent, Fluarix Tetra
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC FLU QuadrivalentBiological
A single dose administration of GC FLU Quadrivalent will be through intramuscular injection.
Fluarix TetraBiological
A single dose administration of Fluarix Tetra will be through intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| GC Flu Quadrivalent | Experimental | Not described Receives: Biological: GC FLU Quadrivalent |
| Fluarix tetra | Active comparator | Not described Receives: Biological: Fluarix Tetra |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Geometric Mean Titer (GMT) Ratio
The non-inferior immunogenicity of GC FLU compared to active control in terms of HAI titers against each virus strain at 21 days after the vaccination.
Measured: 21 days after the vaccination
The Seroconversion Rate
The non-inferior immunogenicity of GC FLU compared to active control in terms of HAI titers against each virus strain at 21 days after the vaccination.
Measured: 21 days after the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start30 Oct 2018
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
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
- None (open label)
- Enrolment
- 842 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medigen Vaccine Biologics Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Szu-Min Hsieh, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718468
- Sponsor's protocol ID
- CT-QV-31
- Status last verified
- Aug 2019
- First submitted
- 22 Oct 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Prospective, Randomized, Open-Labeled, Active-Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine, GC FLU, in Adults Aged 20 to 50
- ClinicalTrials.gov ID
- NCT03718468
- Acronym / sponsor ID
- CT-QV-31
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 842 participants (actual)
- Lead sponsor
- Medigen Vaccine Biologics Corp.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 24 Oct 2018 (actual)
- 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.
This study aims to demonstrate the immunogenic efficacy of GC FLU Quadrivalent Pre-filled Syringe inj. (GC FLU), a quadrivalent influenza virus vaccine, is non-inferior to the active control, Fluarix Tetra. This study is designed to be a randomized, open-labelled, active-controlled, parallel, phase III study recruiting subjects from multiple study sites.
Approximately 840 eligible subjects are planned to enroll in order to obtain 800 evaluable (= per-protocol) subjects. Subjects will be randomized and assigned to GC FLU or Fluarix Tetra (active control, AC) group in 1:1 ratio.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC Flu Quadrivalent | Experimental | Biological: GC FLU Quadrivalent |
| Fluarix tetra | Active comparator | Biological: Fluarix Tetra |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Either gender, aged 20 to 50 years old (inclusive)
- Willing and able to comply with all the required study visits and follow-up defined by this protocol
- Female subject with childbearing potential or male subject with female spouse/partner with childbearing potential must agree to use highly effective contraceptives from 15 days prior to vaccination until 60 days after vaccination. At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include:
Key exclusion criteria (12 listed)
- With previous known or potential exposure to influenza virus within 12 weeks prior to vaccination
- Received seasonal influenza vaccine (registered or investigational) within 24 weeks prior to vaccination
- Received any vaccine other than seasonal influenza vaccine within 6 weeks prior to vaccination
- Received other investigational products (including medications and vaccines) within 6 weeks prior to vaccination
- Administered immunoglobulins and/or other blood products within the 12 weeks prior to vaccination
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 |
|---|---|---|
| GC FLU QuadrivalentA single dose administration of GC FLU Quadrivalent will be through intramuscular injection. | Biological | GC Flu Quadrivalent |
| Fluarix TetraA single dose administration of Fluarix Tetra will be through intramuscular injection. | Biological | Fluarix tetra |
Primary outcome
The Geometric Mean Titer (GMT) Ratio
Time frame: 21 days after the vaccination
The non-inferior immunogenicity of GC FLU compared to active control in terms of HAI titers against each virus strain at 21 days after the vaccination.
The Seroconversion Rate
Time frame: 21 days after the vaccination
The non-inferior immunogenicity of GC FLU compared to active control in terms of HAI titers against each virus strain at 21 days after the 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 14 Aug 2019.
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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.
Szu-Min Hsieh, MD principal investigator
National Taiwan University Hospital
4 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 GC FLU Quadrivalent and Fluarix Tetra in people with Influenza, run by Medigen Vaccine Biologics Corp. at 4 sites in Taiwan.
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 7 inclusion and 12 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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?
The Geometric Mean Titer (GMT) Ratio (time frame: 21 days after the 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 14 Aug 2019.