Status:
COMPLETED
Safety and Protectiveness of the Seasonal Influenza Vaccine for 2010-2011
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
20-59 years
Phase:
PHASE2
Brief Summary
The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1 pandemic of 2009. Many Canadians either had the H1N1 infection or the adjuvanted H1N1 vaccine. Both H1N1 i...
Detailed Description
This study will assess the safety of seasonal influenza vaccination in people who had the adjuvanted H1N1 vaccine last year. It will also measure residual immunity to the H1N1 virus and immune respons...
Eligibility Criteria
Inclusion
- Written informed consent
- Can and will comply with the requirements of the protocol
- Age 20-59 years at Visit 1
- Receipt of one dose of Arepanrix (adjuvanted H1N12009 vaccine, GSK) in 2009 documented by written record or attested by a confident personal recollection (window for vaccination will be 1 October 2009 to January 31, 2010).
Exclusion
- Systemic hypersensitivity to hens' eggs or to any other Fluviral S/F vaccine component such as thimerosal
- History of a life-threatening reaction to any influenza vaccine
- Receipt of non-study TIV for the 2010-2011 season
- Receipt of any live vaccine within 4 weeks or inactivated vaccine within one week of study entry or planned administration of any non-study vaccines during the study period
- Thrombocytopenia or any bleeding disorder that contraindicates IM injection or blood collection
- Pregnancy, at any stage of gestation
- Receipt of blood or any blood-derived products within 3 months prior to Visit 1
- Chronic illness at a stage that could interfere with trial participation (stable health conditions are acceptable, such as diabetes, lung disease, heart conditions etc)
- History of Guillain-Barre syndrome
- Immune compromise as a result of illness or immunosuppressive medication
- Participation in any other research study involving a non-approved drug or medical device
- Any other condition that may interfere with ability to comply with trial procedures, including abuse of alcohol, drug addiction or imposed confinement
- Current febrile illness or oral temperature of ≥ 38.0 °C
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT01140009
Start Date
August 1 2010
End Date
September 1 2010
Last Update
April 15 2015
Active Locations (5)
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1
ACHIEVE Research, Alberta Children's Hospital
Calgary, Alberta, Canada
2
Vaccine Evaluation Center
Vancouver, British Columbia, Canada
3
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
4
McGill University Health Centre - Vaccine Study Centre
Montreal, Quebec, Canada