Status:
COMPLETED
Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza?
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 ...
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 Septembe...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT01001325
Start Date
October 1 2009
End Date
July 1 2010
Last Update
April 20 2012
Active Locations (2)
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1
North York General Hospital
North York, Ontario, Canada, M2K 1E1
2
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5