Prophylaxis Against InfluenzaPhase 3NCT01750814
To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC3102C' Administered Intramuscularly in Healthy Adults
A Phase 3 study testing GC3102C and GC FLU inj. in people with Prophylaxis Against Influenza, run by Green Cross Corporation.
Trial summary
The primary objective is to demonstrate the immunological non-inferiority between GC3102C and GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis Against Influenza
- What is being tested?
- GC3102C and GC FLU inj.
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jul 2013
- 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, 18 to <60 years old
- Subjets willing to provide written informed consent and able to comply with the requirements for the study
Who cannot join
- Subjects with a history of hypersensitivity, especially anaphylactic reactions to egg, egg proteins, chicken or components of vaccine such as gentamicin, gelatin, and arginine
- Subjects with a history of Guillain-Barré syndrome
- Subjects with severe chronic diseases (e.g., cardiovascular diseases without controllable hypertension, hemoglobinopathy, respiratory, metabolic, and renal disorders) who are considered by the investigator to be ineligible for the study
- Subjects previously treated with anti-coagulant therapy or hemophiliac patients who may be at risk of severe hemorrhage after an intramuscular injection
- Subjects who have had an acute febrile (at least 38.0°C) episode at some time during the 72 hours before enrollment
- Subjects who have received a vaccination within 7 days before enrollment or who are scheduled for another vaccination (excluding the study vaccine) during the study
Show all 13Show fewer
- Immunocompromised subjects with immunodeficiency diseases or those who are receiving immunosuppressive or immunomodulatory therapy, e.g., azathioprine, cyclosporin, interferon, granulocyte-colony stimulating factor, tacrolimus, everolimus, sirolimus
- Subjects who have received high-dose corticosteroids in the 3 months before vaccination or who will be administered a cumulative dose of 700 mg of corticosteroids during the study. Inhaled, intranasal, and local application of corticosteroids is permitted, regardless of dosage, and corticosteroids such as prednisolone at a maximum dose of 15 mg/day are allowed
- Subjects who have been administered immunoglobulins or blood-derived products 3 months before enrollment or who are scheduled for the administration during the study
- Subjects who have received an influenza vaccine within 6 months of enrollment
- A female subject who is pregnant or who is breast-feeding. Subjects of childbearing potential without an appropriate contraceptive measure within 30 days before enrollment and who do not agree to use a clinically acceptable method of birth control during the study (e.g., oral contraceptives, condom, diaphragm or intrauterine device, or vasectomy of male partner)
- Subjects who have participated in any other clinical trials within 30 days of the administration of the study vaccine
- Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study
About this study
Official title: A Phase III, Randomized, Double-blind, Multi-center Study to Compare the Immunological Efficacy and Safety of GC3102C With GC FLU Inj. Administered Intramuscularly in Healthy Adults
The primary objective is to demonstrate the immunological non-inferiority between GC3102C and GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults
- Conditions
- Prophylaxis Against Influenza
- Being tested
- GC3102C, GC FLU inj.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC3102CBiological
a single dose (0.5 mL) intramuscularly on the deltoid muscle
GC FLU inj.Biological
a single dose (0.5 mL) intramuscularly on the deltoid muscle
| Study group | Role | What they receive |
|---|---|---|
| GC FLU inj. | Active comparator | Influneza vaccine, single-dose vial Receives: Biological: GC FLU inj. |
| GC3102C | Experimental | Influneza vaccine, multi-dose vial Receives: Biological: GC3102C |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT, using the Hemagglutination inhibition(HI) antibody titer
Measured: Day 21
Secondary outcomes (4)
Rate of subjects achieving seroconversion
Measured: Day 0 , Day 21
Rate of subjects achieving seroprotection
Measured: Day 21
Number of Participants Reporting a Solicited Adverse Events After Vaccination
Measured: Day 6
Number of Participants Reporting a Unsolicited Adverse Events After Vaccination
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylaxis Against 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 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
- NCT01750814
- Sponsor's protocol ID
- GC3102C_P3
- Status last verified
- Jan 2016
- First submitted
- 12 Dec 2012
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Multi-center Study to Compare the Immunological Efficacy and Safety of GC3102C With GC FLU Inj. Administered Intramuscularly in Healthy Adults
- ClinicalTrials.gov ID
- NCT01750814
- Acronym / sponsor ID
- GC3102C_P3
- Conditions
- Prophylaxis Against Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Dec 2012 (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 primary objective is to demonstrate the immunological non-inferiority between GC3102C and GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults
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 |
|---|---|---|
| GC FLU inj. | Active comparator | Biological: GC FLU inj.Influneza vaccine, single-dose vial |
| GC3102C | Experimental | Biological: GC3102CInfluneza vaccine, multi-dose vial |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults, 18 to <60 years old
- Subjets willing to provide written informed consent and able to comply with the requirements for the study
Key exclusion criteria (13 listed)
- Subjects with a history of hypersensitivity, especially anaphylactic reactions to egg, egg proteins, chicken or components of vaccine such as gentamicin, gelatin, and arginine
- Subjects with a history of Guillain-Barré syndrome
- Subjects with severe chronic diseases (e.g., cardiovascular diseases without controllable hypertension, hemoglobinopathy, respiratory, metabolic, and renal disorders) who are considered by the investigator to be ineligible for the study
- Subjects previously treated with anti-coagulant therapy or hemophiliac patients who may be at risk of severe hemorrhage after an intramuscular injection
- Subjects who have had an acute febrile (at least 38.0°C) episode at some time during the 72 hours before 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 |
|---|---|---|
| GC3102Ca single dose (0.5 mL) intramuscularly on the deltoid muscle | Biological | GC3102C |
| GC FLU inj.a single dose (0.5 mL) intramuscularly on the deltoid muscle | Biological | GC FLU inj. |
Primary outcome
GMT, using the Hemagglutination inhibition(HI) antibody titer
Time frame: Day 21
4 secondary outcomes
Rate of subjects achieving seroconversion
Time frame: Day 0 , Day 21
Rate of subjects achieving seroprotection
Time frame: Day 21
Number of Participants Reporting a Solicited Adverse Events After Vaccination
Time frame: Day 6
Number of Participants Reporting a Unsolicited Adverse Events After Vaccination
Time frame: Day 21
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 15 Jan 2016.
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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 GC3102C and GC FLU inj. in people with Prophylaxis Against Influenza, 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 2 inclusion and 13 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 15 Jan 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?
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, using the Hemagglutination inhibition(HI) antibody titer (time frame: Day 21). 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 15 Jan 2016.