InfluenzaPhase 1NCT00966342
Rapid Evaluation of Seasonal Influenza Vaccine
A Phase 1 study testing Fluviral 2009/10 in people with Influenza, run by University of British Columbia at 3 sites in Canada.
Trial summary
This is an invitation to consider taking part in a research study occurring just before the upcoming influenza vaccination program across Canada. The purpose of the study is to closely assess influenza vaccine safety and immune responses, as part of a nationwide, annual surveillance project sponsored by the Public… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluviral 2009/10
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesCanada
- Study dates
- Aug 2009to Nov 2009
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligibility Inclusion:
- Good general health
- Written informed consent
- Adults 20-64 years of age
Who cannot join
- compromised immune system
- allergies to eggs or thimerosol
- life-threatening reaction to previous Flu vaccine
- chronic illness, bleeding disorder
- any Flu vaccine within 6 mths planning any other vaccine during study
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
KFLA Public Health Department
Kingston, Ontario
CHUQ de recherché
Québec, Quebec
Mt Sinai Hospital
Toronto, Ontario
About this study
Official title: Post-marketing Surveillance of Annual Influenza Vaccines: Extended Vaccine Safety and Immunogenicity Evaluation
This is an invitation to consider taking part in a research study occurring just before the upcoming influenza vaccination program across Canada. The purpose of the study is to closely assess influenza vaccine safety and immune responses, as part of a nationwide, annual surveillance project sponsored by the Public Health Agency of Canada. Such scrutiny is important given the changing nature of flu vaccines from year to year.
Read the detailed description
Trivalent inactivated vaccines (TIVs) are the principal tools for minimizing seasonal influenza morbidity and mortality in populations at increased risk of adverse outcomes. To keep pace with the evolution of circulating viruses the composition of TIVs is annually updated. Depending upon circumstances, the seasonal formulation may contain 1-3 new variant strains representing Canada's supply of H1N1, H3N2 and B 2009 vaccine. Standardized manufacturing processes favour consistent vaccine safety and immunogenicity profiles from year to year but unanticipated differences can and do occur. As a consequence of the unusual occurrence of "oculorespiratory syndrome" in recipients of a Canadian-made TIV for 2000-2001, the Canadian regulatory agency has required pre-approval clinical testing of seasonal vaccines in adults. This small scale testing (120 subjects) cannot exclude the occurrence of infrequent, troublesome adverse effects. Expanded testing is desirable and would best be done soon after vaccines are approved for distribution so that results could inform the public vaccination programs that follow. Having an established capacity for rapid evaluation of a new influenza vaccine will be invaluable in the event of a pandemic, when vaccines will be less thoroughly tested before being made available to protect the public.
The objectives of this study are two-fold:
- To assess the safety and immunogenicity of a seasonal TIV influenza vaccine quickly enough to inform subsequent public delivery programs.
- To use the opportunity to refine preparedness for rapid evaluation of a pandemic influenza vaccine.
- Conditions
- Influenza
- Being tested
- Fluviral 2009/10
- Keywords
- vaccine, influenza, influenza vaccine, pandemic preparedness
- 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 2009/10Drug
single dose given IM .05 mL
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Other | Everyone gets licensed Influenza vaccine Receives: Drug: Fluviral 2009/10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety and immunogenicity of the licensed Influenza vaccine Fluviral 2009/10 measured at 7 and 21 days for safety and 21 days for immunogenicity
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2009 (estimated)
- Study completionNov 2009 (estimated)
Why it stopped: New studies are being offered
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 University of British ColumbiaThe 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- David Scheifele, Dr., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966342
- Sponsor's protocol ID
- H07-01465
- Status last verified
- Oct 2009
- First submitted
- 24 Aug 2009
- Last updated
- 23 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance of Annual Influenza Vaccines: Extended Vaccine Safety and Immunogenicity Evaluation
- ClinicalTrials.gov ID
- NCT00966342
- Acronym / sponsor ID
- H07-01465
- Conditions
- Influenza
- Keywords
- vaccine, influenza, influenza vaccine, pandemic preparedness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New studies are being offered
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 26 Aug 2009 (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.
This is an invitation to consider taking part in a research study occurring just before the upcoming influenza vaccination program across Canada. The purpose of the study is to closely assess influenza vaccine safety and immune responses, as part of a nationwide, annual surveillance project sponsored by the Public Health Agency of Canada. Such scrutiny is important given the changing nature of flu vaccines from year to year.
Detailed description
Trivalent inactivated vaccines (TIVs) are the principal tools for minimizing seasonal influenza morbidity and mortality in populations at increased risk of adverse outcomes. To keep pace with the evolution of circulating viruses the composition of TIVs is annually updated. Depending upon circumstances, the seasonal formulation may contain 1-3 new variant strains representing Canada's supply of H1N1, H3N2 and B 2009 vaccine. Standardized manufacturing processes favour consistent vaccine safety and immunogenicity profiles from year to year but unanticipated differences can and do occur. As a consequence of the unusual occurrence of "oculorespiratory syndrome" in recipients of a Canadian-made TIV for 2000-2001, the Canadian regulatory agency has required pre-approval clinical testing of seasonal vaccines in adults. This small scale testing (120 subjects) cannot exclude the occurrence of infrequent, troublesome adverse effects. Expanded testing is desirable and would best be done soon after vaccines are approved for distribution so that results could inform the public vaccination programs that follow. Having an established capacity for rapid evaluation of a new influenza vaccine will be invaluable in the event of a pandemic, when vaccines will be less thoroughly tested before being made available to protect the public.
The objectives of this study are two-fold:
- To assess the safety and immunogenicity of a seasonal TIV influenza vaccine quickly enough to inform subsequent public delivery programs.
- To use the opportunity to refine preparedness for rapid evaluation of a pandemic influenza vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Other | Drug: Fluviral 2009/10Everyone gets licensed Influenza vaccine |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Good general health
- Written informed consent
- Adults 20-64 years of age
Key exclusion criteria (5 listed)
- compromised immune system
- allergies to eggs or thimerosol
- life-threatening reaction to previous Flu vaccine
- chronic illness, bleeding disorder
- any Flu vaccine within 6 mths planning any other vaccine during study
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 2009/10single dose given IM .05 mL | Drug | Vaccine |
Primary outcome
Assess the safety and immunogenicity of the licensed Influenza vaccine Fluviral 2009/10 measured at 7 and 21 days for safety and 21 days for immunogenicity
Time frame: 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2009.
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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.
David Scheifele, Dr. principal investigator
University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluviral 2009/10 in people with Influenza, run by University of British Columbia at 3 sites in Canada.
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 5 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: withdrawn, as of the sponsor's last update on 23 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Assess the safety and immunogenicity of the licensed Influenza vaccine Fluviral 2009/10 measured at 7 and 21 days for safety and 21 days for immunogenicity (time frame: 21 days). 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 23 Oct 2009.