InfluenzaPhase 3NCT00232947
Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over
A Phase 3 study testing Influenza virus vaccine (Fluviral) and Influenza virus vaccine (Fluzone) in people with Influenza, run by ID Biomedical Corporation, Quebec at 10 sites in United States.
Trial summary
The goal of this study is to determine whether the immune responses induced by Fluviral, the investigational vaccine, are comparable to those induced by Fluzone, which is an influenza vaccine currently licensed in the U.S. The study focuses on persons 50 years old and over. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza virus vaccine (Fluviral) and Influenza virus vaccine (Fluzone)
- Type of treatment
- Vaccines
- How many people
- 900 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2005to Feb 2006
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stable health status
- Access to a consistent means of telephone contact.
- Comprehension of study requirements, availability for study duration
- Availability and ability to attend scheduled visits
- Females post menopausal, sterile or using accepted contraceptive measures
- Competence to provide informed consent
Who cannot join
- Presence of significant acute or chronic medical or neuropsych. illness
- New medical or surgical treatment w/i 1 month
- Change in medication dose due to uncontrolled symptoms w/i 1 month
- Hospitalization w/i 1 month
- Any unusual risk (for age group) of serious adverse events w/i 1 month
- Any neuropsychiatric condition altering competence for consent
Show all 26Show fewer
- Any neuropsychiatric condition preventing accurate safety reports
- Febrile illness on day of treatment
- Employment in professions at high risk of influenza transmission
- Residence in a long-term-care facility or with an immunocompromised person
- Systolic BP over 150, diastolic over 90, resting pulse under 50 or over 100
- Cancer w/i 3 years
- Immunosuppressive of immunodeficient conditions
- Treatment with systemic glucocorticoids > replacement
- Treatment with cytotoxic or immunosuppressant drugs
- Treatment with immune globulins
- Clotting disorders that increase the risks of intramuscular injections
- History of demyelinating disease or GBS
- Pregnancy or nursing
- Absence of contraceptive practices in women with childbearing potential
- Planned administration of non-influenza vaccines within 30 days
- Receipt of any investigational drug within 30 days
- Receipt of immune globulin treatment within 3 months
- Known or suspected allergy to egg proteins, gelatin, or thimerosal
- History of severe adverse reactions toflu vaccines
- Prior receipt of 2005-6 influenza vaccine
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Radiant Research
Atlanta, Georgia, 30342
Radiant Research
Chicago, Illinois, 60610
Radiant Research
Cincinnati, Ohio, 45236
Regional Clinical Research
Endwell, New York, 13760
PI-Coor Clinical Research
Fairfax, Virginia, 22030
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Vince and Associates Clinical Research
Overland Park, Kansas, 66211
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
University of Rochester Medical Center
Rochester, New York, 14642
Omega Medical Research
Warwick, Rhode Island, 02886
About this study
Official title: A Non-Inferiority Comparison of Fluviral™ Influenza Vaccine to a U.S. Licensed Inactivated Split-Virion Vaccine (Fluzone®) in Adults ≥ 50 Years Old Living in the Community
The goal of this study is to determine whether the immune responses induced by Fluviral, the investigational vaccine, are comparable to those induced by Fluzone, which is an influenza vaccine currently licensed in the U.S. The study focuses on persons 50 years old and over. In addition, the study will compare the rate of reactions to the two vaccines, and the general health of persons who receive them over the 42 days after immunization.
Read the detailed description
Yearly influenza epidemics are responsible for excess hospitalizations and deaths in the elderly population, and also cause lost work and productivity among the healthy, working elderly. Fluviral, a product now licensed in Canada, is being tested to determine whether it is as active in causing immune responses, and as safe as a currently licensed U.S. vaccine in persons 50 y.o. and over.
- Conditions
- Influenza
- Being tested
- Influenza virus vaccine (Fluviral), Influenza virus vaccine (Fluzone)
- Keywords
- vaccine, elderly, immunogenicity, safety
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza virus vaccine (Fluviral)Biological
Influenza virus vaccine (Fluzone)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of signficant rises in serum antibody titers against viruses in the vaccines.
Geometric mean serum antibody titers on day 21.
Secondary outcomes (2)
Rates of specific, solicited vaccine reactogenicicty complaints.
Rates of adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startOct 2005
- Study completionFeb 2006
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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- ID Biomedical Corporation, Quebec
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nancy Bouveret, MD, Study director, ID Biomedical of Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232947
- Sponsor's protocol ID
- IDB707-108
- Status last verified
- Oct 2005
- First submitted
- 3 Oct 2005
- Last updated
- 22 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Inferiority Comparison of Fluviral™ Influenza Vaccine to a U.S. Licensed Inactivated Split-Virion Vaccine (Fluzone®) in Adults ≥ 50 Years Old Living in the Community
- ClinicalTrials.gov ID
- NCT00232947
- Acronym / sponsor ID
- IDB707-108
- Conditions
- Influenza
- Keywords
- vaccine, elderly, immunogenicity, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- ID Biomedical Corporation, QuebecIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Feb 2006
- First posted
- 5 Oct 2005 (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 goal of this study is to determine whether the immune responses induced by Fluviral, the investigational vaccine, are comparable to those induced by Fluzone, which is an influenza vaccine currently licensed in the U.S. The study focuses on persons 50 years old and over. In addition, the study will compare the rate of reactions to the two vaccines, and the general health of persons who receive them over the 42 days after immunization.
Detailed description
Yearly influenza epidemics are responsible for excess hospitalizations and deaths in the elderly population, and also cause lost work and productivity among the healthy, working elderly. Fluviral, a product now licensed in Canada, is being tested to determine whether it is as active in causing immune responses, and as safe as a currently licensed U.S. vaccine in persons 50 y.o. and over.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stable health status
- Access to a consistent means of telephone contact.
- Comprehension of study requirements, availability for study duration
- Availability and ability to attend scheduled visits
- Females post menopausal, sterile or using accepted contraceptive measures
Key exclusion criteria (26 listed)
- Presence of significant acute or chronic medical or neuropsych. illness
- New medical or surgical treatment w/i 1 month
- Change in medication dose due to uncontrolled symptoms w/i 1 month
- Hospitalization w/i 1 month
- Any unusual risk (for age group) of serious adverse events w/i 1 month
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 |
|---|---|---|
| Influenza virus vaccine (Fluviral) | Biological | – |
| Influenza virus vaccine (Fluzone) | Biological | – |
Primary outcome
Rate of signficant rises in serum antibody titers against viruses in the vaccines.
Geometric mean serum antibody titers on day 21.
2 secondary outcomes
Rates of specific, solicited vaccine reactogenicicty complaints.
Rates of adverse events.
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 22 Jan 2007.
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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.
Nancy Bouveret, MD study director
ID Biomedical of Quebec
10 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 Influenza virus vaccine (Fluviral) and Influenza virus vaccine (Fluzone) in people with Influenza, run by ID Biomedical Corporation, Quebec at 10 sites in United States.
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 6 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 22 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Rate of signficant rises in serum antibody titers against viruses in the vaccines.. 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 22 Jan 2007.