InfluenzaPhase 3NCT01389479
Study to Evaluate the Safety, Tolerance and Immunogenicity of Fluviral™ in Healthy Adults
A Phase 3 study testing Fluviral™ and Fluzone® in people with Influenza, run by GlaxoSmithKline.
Trial summary
The purpose of the study is to evaluate the safety, tolerance and immunogenicity of Fluviral™ in healthy adults aged 18-64 years. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluviral™ and Fluzone®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to May 2005
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female.
- Adults 18-64 years of age, inclusive.
- Satisfactory baseline medical assessment by history, physical examination, and clinical laboratory testing.
- Capable of informed consent.
- Able, willing and likely to fully comply with study procedures and restrictions.
Who cannot join
- Acute illness at the time of enrollment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection and/or chronic use of immunosuppressants of other immune-modifying drugs within 6 months of administration of the study vaccine.
- Presence of an unstable chronic illness.
- Complicated diabetes mellitus.
- Active neurological disorder.
- History of any demyelinating disease including Guillain-Barré syndrome.
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- Any clinical laboratory abnormality.
- Any disorder of coagulation or treatment with coumadin derivatives or heparin.
- Vital sign abnormalities at screening.
- Acute or chronic liver, renal or inflammatory bowel disease or collagen vascular disease.
- Cancer, or treatment for cancer, within three years.
- History of significant alcohol or drug abuse within one year prior to the screening visit.
- Positive urine drug screen at screening within 3 months prior to the screening visit or hard drugs. Products such as ativan, tylenol with codeine should be stopped sufficiently ahead of the screening visit in order to avoid a positive urine drug screen.
- Positive testing for hepatitis B, hepatitis C or human immunodeficiency virus at screening.
- Receipt of an influenza vaccine within 9 months prior to dosing.
- Planned administration of any other vaccines 30 days before study immunization or during the course of the study. Immunization on an emergency basis, such as Tetanus and Diphtheria Toxoids Adsorbed for adult use, will be allowed provided the vaccine is not administered within two weeks prior to study immunization.
- Use of any investigational or non-registered drug or vaccine or participation in an investigational study within 30 days prior to administration of study vaccine, or planned use during the study period.
- Receipt of any immunoglobulins and/or any blood products within three months of screening or planned administration of any of these products during the study period.
- Receipt of a depot injection or an implant of any drug within 3 months prior to administration of study vaccine.
- Any known or suspected allergy to any constituent of Fluviral™ S/F or Fluzone®.
- A history of severe adverse reaction to a previous dose of any influenza vaccine.
- History of anaphylactic type reactions to consumption of eggs.
- Any other condition or social circumstance that, in the opinion of the Principal Investigator, would make the subject unsuitable for or unable to complete the study.
- Breast-feeding subject.
- Positive urine pregnancy test at screening.
- Female subjects having sexual intercourse with any non-sterile male partner within 14 days prior to vaccine administration and without a history of acceptable contraception.
About this study
Official title: Active-control Study to Evaluate the Safety, Tolerance and Immunogenicity of Fluviral™ S/F Influenza Vaccine in Healthy Adults Aged 18-64 Years of Age
The purpose of the study is to evaluate the safety, tolerance and immunogenicity of Fluviral™ in healthy adults aged 18-64 years.
Read the detailed description
This study was conducted by ID BioMedical which has been taken over by GlaxoSmithKline. At the time of conduct of this study, Fluviral was produced by ID BioMedical.
- Conditions
- Influenza
- Being tested
- Fluviral™, Fluzone®
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluviral™Biological
Intramuscular, single dose
Fluzone®Biological
Intramuscular, single dose
| Study group | Role | What they receive |
|---|---|---|
| Fluviral Group | Experimental | Not described Receives: Biological: Fluviral™ |
| Fluzone Group | Active comparator | Not described Receives: Biological: Fluzone® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with solicited local and systemic reactogenicity symptoms
Measured: First three days after vaccination
Number of subjects reporting spontaneous adverse events
Measured: Throughout the entire study period (Day 0-42)
Immune response in terms of number of seroconverted subjects
Measured: Before (Day 0) and after (Day 21) vaccination
Immune response in terms of number of seroprotected subjects
Measured: Before (Day 0) and after (Day 21) vaccination
Secondary outcomes (2)
Immunogenicity with respect to components of the study vaccine in terms of number of subjects with titres above the pre-defined cut-off
Titres calculated as geometric mean
Measured: At Day 21 after vaccination
Immune response to components of the study vaccine in terms of mean Geometric increase
Measured: At Day 21 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJan 2005
- Primary completionMay 2005
- Study completionMay 2005
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.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ID Biomedical Corporation, Quebec
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389479
- Sponsor's protocol ID
- IDB-707-105
- Status last verified
- May 2017
- First submitted
- 4 Jul 2011
- Last updated
- 8 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active-control Study to Evaluate the Safety, Tolerance and Immunogenicity of Fluviral™ S/F Influenza Vaccine in Healthy Adults Aged 18-64 Years of Age
- ClinicalTrials.gov ID
- NCT01389479
- Acronym / sponsor ID
- IDB-707-105
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- ID Biomedical Corporation, Quebec
- Study start
- Jan 2005
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 8 Jul 2011 (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 the study is to evaluate the safety, tolerance and immunogenicity of Fluviral™ in healthy adults aged 18-64 years.
Detailed description
This study was conducted by ID BioMedical which has been taken over by GlaxoSmithKline. At the time of conduct of this study, Fluviral was produced by ID BioMedical.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluviral Group | Experimental | Biological: Fluviral™ |
| Fluzone Group | Active comparator | Biological: Fluzone® |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female.
- Adults 18-64 years of age, inclusive.
- Satisfactory baseline medical assessment by history, physical examination, and clinical laboratory testing.
- Capable of informed consent.
- Able, willing and likely to fully comply with study procedures and restrictions.
Key exclusion criteria (26 listed)
- Acute illness at the time of enrollment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection and/or chronic use of immunosuppressants of other immune-modifying drugs within 6 months of administration of the study vaccine.
- Presence of an unstable chronic illness.
- Complicated diabetes mellitus.
- Active neurological disorder.
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 |
|---|---|---|
| Fluviral™Intramuscular, single dose | Biological | Fluviral Group |
| Fluzone®Intramuscular, single dose | Biological | Fluzone Group |
Primary outcome
Number of subjects with solicited local and systemic reactogenicity symptoms
Time frame: First three days after vaccination
Number of subjects reporting spontaneous adverse events
Time frame: Throughout the entire study period (Day 0-42)
Immune response in terms of number of seroconverted subjects
Time frame: Before (Day 0) and after (Day 21) vaccination
Immune response in terms of number of seroprotected subjects
Time frame: Before (Day 0) and after (Day 21) vaccination
2 secondary outcomes
Immunogenicity with respect to components of the study vaccine in terms of number of subjects with titres above the pre-defined cut-off
Time frame: At Day 21 after vaccination
Immune response to components of the study vaccine in terms of mean Geometric increase
Time frame: At Day 21 after 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 8 Jun 2017.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluviral™ and Fluzone® in people with Influenza, run by GlaxoSmithKline.
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 5 inclusion and 26 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 8 Jun 2017. 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?
Number of subjects with solicited local and systemic reactogenicity symptoms (time frame: First three days after 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 8 Jun 2017.