Influenza Clinical Trial
Official title:
A Randomized Controlled Trial of the Effect of Seasonal Influenza Vaccination on the Incidence of Infection Due to the 2009 H1N1 Influenza
Verified date | April 2012 |
Source | Mount Sinai Hospital, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 468 |
Est. completion date | July 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. 18 to 60 years old, inclusive, as of September 1st, 2009; 2. understand the study, agree to its provisions, and give written informed consent prior to entry; 3. available for follow-up during the study period; 4. have convenient access to a computer with internet access and basic skills for use of the internet; Exclusion Criteria: 1. planning to spend more than two consecutive weeks outside of Canada from October 1, 2009 to April 15th 2010. 2. received immunoglobulin within six months of study entry; 3. has already received a 2009 seasonal influenza vaccine (southern or northern hemisphere) 4. has had laboratory-confirmed infection with 2009 H1N1 influenza 5. is participating in a clinical trial that would result in the receipt of investigational medication during the study period; 6. allergic to eggs, to influenza vaccine, or any components of the seasonal influenza vaccine 7. has had a previous severe adverse event associated with an influenza vaccine 8. has a significant chronic underlying illness that would warrant seasonal influenza vaccine in a usual year, or is known to be pregnant. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Canada | North York General Hospital | North York | Ontario |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Mount Sinai Hospital, Canada | GlaxoSmithKline |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | day +7 post seasonal influenza vaccination (or placebo) to end of study | No |
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