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
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
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