InfluenzaPhase 3NCT01001325
Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza?
A Phase 3 study testing Fluviral influenza vaccine, 2009-2010 and Normal saline in people with Influenza, run by Mount Sinai Hospital, Canada at 2 sites in Canada.
Trial summary
Since the onset of the 2009 pandemic, several observational public health investigations in Canada have identified evidence that suggests that adults, particularly younger adults, who have previously received seasonal influenza vaccine are at increased risk of infection with the 2009 pandemic strain of H1N1 (pH1N1). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluviral influenza vaccine, 2009-2010 and Normal saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2009to Jul 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 to 60 years old, inclusive, as of September 1st, 2009;
- understand the study, agree to its provisions, and give written informed consent prior to entry;
- available for follow-up during the study period;
- have convenient access to a computer with internet access and basic skills for use of the internet;
Who cannot join
- planning to spend more than two consecutive weeks outside of Canada from October 1, 2009 to April 15th 2010.
- received immunoglobulin within six months of study entry;
- has already received a 2009 seasonal influenza vaccine (southern or northern hemisphere)
- has had laboratory-confirmed infection with 2009 H1N1 influenza
- is participating in a clinical trial that would result in the receipt of investigational medication during the study period;
- allergic to eggs, to influenza vaccine, or any components of the seasonal influenza vaccine
- has had a previous severe adverse event associated with an influenza vaccine
- has a significant chronic underlying illness that would warrant seasonal influenza vaccine in a usual year, or is known to be pregnant.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
North York General Hospital
North York, Ontario, M2K 1E1
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
About this study
Official title: A Randomized Controlled Trial of the Effect of Seasonal Influenza Vaccination on the Incidence of Infection Due to the 2009 H1N1 Influenza
Since the onset of the 2009 pandemic, several observational public health investigations in Canada have identified evidence that suggests that adults, particularly younger adults, who have previously received seasonal influenza vaccine are at increased risk of infection with the 2009 pandemic strain of H1N1 (pH1N1). Investigations in Australia, the United States and the United Kingdom have not identified this effect. While it is not possible to have an answer to whether this affect is real prior to the second wave of the 2009 pandemic, it remains vital to future influenza vaccination programs that the hypothesis that, in 2009, seasonal vaccine increases or decreases the risk of pH1N1 infection be confirmed or refuted.
The objective of this study is to determine whether Ontario adults aged 18-60 years who receive the 2009 seasonal influenza vaccine will be at a 2 fold or greater increased risk of infection with influenza pH1N1 during the second or third wave of the 2009 pandemic.
Read the detailed description
This study will be an observer -blind randomized controlled trial.
This study will primarily recruit patients from an existing cohort of adult health care and other workers in Toronto, as of September 15, 2009, almost 1000 adults are participating in this cohort; with approximately 75 new cohort members being recruited weekly (target is 1300). Recruitment will be supplemented by enrollment at Hamilton Health Sciences Centre (N~3920 employees plus physicians \& midwives) and Queen Elizabeth II Health Centre in Halifax (N~6000 employees plus physicians \& midwives).
To date, health care workers in the Toronto cohort have been recruited at the Mount Sinai Hospital, Toronto East General Hospital, and North York General Hospital. Recruitment is just beginning at Sunnybrook Health Sciences Centre, and the University Health Network.
Non-health care workers are being recruited from several large Toronto employers of primarily office workers. These include the Ontario Agency for Health Protection and Promotion, the head offices of the Ontario Power Generation Corporation, the Art Gallery of Ontario, and the head offices of Scotia Bank. Non-health care workers should meet inclusion criteria and should not work primarily with children or from a home office.
Participants in the study are completing web-based diaries weekly, and, whenever they develop symptoms possibly compatible with influenza, are submitting nasal swabs, and completing symptom diaries daily while ill. Nasal swabs are tested by polymerase chain reaction (PCR) on a same or next day basis with antivirals prescribed to participants who develop influenza.
- Conditions
- Influenza
- Being tested
- Fluviral influenza vaccine, 2009-2010, Normal saline
- Keywords
- influenza, vaccine, observer blind
- 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 influenza vaccine, 2009-2010Biological
0.5 mL intramuscular
Normal salineBiological
0.5 mL intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Seasonal influenza vaccination | Experimental | Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification Receives: Biological: Fluviral influenza vaccine, 2009-2010 |
| Placebo | Placebo comparator | 0.5 mL normal saline Receives: Biological: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab
Influenza infection (pH1N1) as diagnosed by PCR from self-collected mid-turbinate swab. Participant is asked to collect a swab when they have symptoms possibly compatible with an acute viral respiratory illness: 1) fever without another obvious source, 2) at least two new respiratory symptoms (runny or stuffy nose, sneezing, sore or scratchy throat, hoarseness, cough), or 3) one respiratory symptom (as above) and one systemic symptom (fever, malaise, muscle aches, headache, fatigue)
Measured: day +7 post seasonal influenza vaccination (or placebo) to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Allison J McGeer, MD, Principal investigator, MOUNT SINAI HOSPITALBrenda L. Coleman, PhD, Principal investigator, MOUNT SINAI HOSPITALNatasha Crowcroft, MD, Principal investigator, Ontario Agency for Health Protection & PromotionKaren Green, MSc, Study director, MOUNT SINAI HOSPITALKevin Katz, MD, Study director, North York General HospitalMark Loeb, MD, Study director, Hamilton Health Sciences CentreDonald Low, MD, Study director, MOUNT SINAI HOSPITALShelly McNeil, MD, Study director, Queen Elizabeth II Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001325
- Sponsor's protocol ID
- CRT113936
- Status last verified
- Apr 2012
- First submitted
- 23 Oct 2009
- Last updated
- 20 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effect of Seasonal Influenza Vaccination on the Incidence of Infection Due to the 2009 H1N1 Influenza
- ClinicalTrials.gov ID
- NCT01001325
- Acronym / sponsor ID
- CRT113936
- Conditions
- Influenza
- Keywords
- influenza, vaccine, observer blind
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Posted 15 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since the onset of the 2009 pandemic, several observational public health investigations in Canada have identified evidence that suggests that adults, particularly younger adults, who have previously received seasonal influenza vaccine are at increased risk of infection with the 2009 pandemic strain of H1N1 (pH1N1). Investigations in Australia, the United States and the United Kingdom have not identified this effect. While it is not possible to have an answer to whether this affect is real prior to the second wave of the 2009 pandemic, it remains vital to future influenza vaccination programs that the hypothesis that, in 2009, seasonal vaccine increases or decreases the risk of pH1N1 infection be confirmed or refuted.
The objective of this study is to determine whether Ontario adults aged 18-60 years who receive the 2009 seasonal influenza vaccine will be at a 2 fold or greater increased risk of infection with influenza pH1N1 during the second or third wave of the 2009 pandemic.
Detailed description
This study will be an observer -blind randomized controlled trial.
This study will primarily recruit patients from an existing cohort of adult health care and other workers in Toronto, as of September 15, 2009, almost 1000 adults are participating in this cohort; with approximately 75 new cohort members being recruited weekly (target is 1300). Recruitment will be supplemented by enrollment at Hamilton Health Sciences Centre (N~3920 employees plus physicians \& midwives) and Queen Elizabeth II Health Centre in Halifax (N~6000 employees plus physicians \& midwives).
To date, health care workers in the Toronto cohort have been recruited at the Mount Sinai Hospital, Toronto East General Hospital, and North York General Hospital. Recruitment is just beginning at Sunnybrook Health Sciences Centre, and the University Health Network.
Non-health care workers are being recruited from several large Toronto employers of primarily office workers. These include the Ontario Agency for Health Protection and Promotion, the head offices of the Ontario Power Generation Corporation, the Art Gallery of Ontario, and the head offices of Scotia Bank. Non-health care workers should meet inclusion criteria and should not work primarily with children or from a home office.
Participants in the study are completing web-based diaries weekly, and, whenever they develop symptoms possibly compatible with influenza, are submitting nasal swabs, and completing symptom diaries daily while ill. Nasal swabs are tested by polymerase chain reaction (PCR) on a same or next day basis with antivirals prescribed to participants who develop influenza.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seasonal influenza vaccination | Experimental | Biological: Fluviral influenza vaccine, 2009-2010Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification |
| Placebo | Placebo comparator | Biological: Normal saline0.5 mL normal saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 60 years old, inclusive, as of September 1st, 2009;
- understand the study, agree to its provisions, and give written informed consent prior to entry;
- available for follow-up during the study period;
- have convenient access to a computer with internet access and basic skills for use of the internet;
Key exclusion criteria (8 listed)
- planning to spend more than two consecutive weeks outside of Canada from October 1, 2009 to April 15th 2010.
- received immunoglobulin within six months of study entry;
- has already received a 2009 seasonal influenza vaccine (southern or northern hemisphere)
- has had laboratory-confirmed infection with 2009 H1N1 influenza
- is participating in a clinical trial that would result in the receipt of investigational medication during the study period;
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 influenza vaccine, 2009-20100.5 mL intramuscular | Biological | Seasonal influenza vaccination |
| Normal saline0.5 mL intramuscular | Biological | Placebo |
Primary outcome
Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab
Time frame: day +7 post seasonal influenza vaccination (or placebo) to end of study
Influenza infection (pH1N1) as diagnosed by PCR from self-collected mid-turbinate swab. Participant is asked to collect a swab when they have symptoms possibly compatible with an acute viral respiratory illness: 1) fever without another obvious source, 2) at least two new respiratory symptoms (runny or stuffy nose, sneezing, sore or scratchy throat, hoarseness, cough), or 3) one respiratory symptom (as above) and one systemic symptom (fever, malaise, muscle aches, headache, fatigue)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Allison J McGeer, MD principal investigator
MOUNT SINAI HOSPITAL
Brenda L. Coleman, PhD principal investigator
MOUNT SINAI HOSPITAL
Natasha Crowcroft, MD principal investigator
Ontario Agency for Health Protection & Promotion
2 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 Fluviral influenza vaccine, 2009-2010 and Normal saline in people with Influenza, run by Mount Sinai Hospital, Canada at 2 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 8 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 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab (time frame: day +7 post seasonal influenza vaccination (or placebo) to end of study). 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 20 Apr 2012; AzTrials last refreshed its copy on 8 Nov 2026.