Status:
COMPLETED
Evaluation of Seasonal Influenza Vaccine for 2010-2011 in Young Children
Lead Sponsor:
Dalhousie University
Collaborating Sponsors:
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Conditions:
Seasonal Influenza
Eligibility:
All Genders
12-59 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 children either had the H1N1 infection or the adjuvanted H1N1 vaccine. Both H1N1 in...
Detailed Description
This study will assess the safety of seasonal influenza vaccination in children who received one or two doses of the adjuvanted H1N1 vaccine last year. It will also measure residual immunity to the H1...
Eligibility Criteria
Inclusion
- Written informed consent provided for the subject by a parent or legal guardian.
- Subjects whose parents the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations, able to converse with study personnel including by telephone).
- Age 12-59 months at Visit 1, male or female
- Receipt of one or two doses of Arepanrix (adjuvanted H1N12009 vaccine, GlaxoSmithKline (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 Arepanrix after January 31st , 2010
- Receipt of non-study TIV (Trivalent Influenza Vaccine)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
- Receipt of blood or any blood-derived products within the past 3 months
- Chronic illness at a stage that could interfere with trial participation (stable health conditions are acceptable, such as diabetes, lung disease, heart conditions etc)
- Immune compromise as a result of a medical condition, transplantation or immunosuppressive medication, not including topical or aerosol medications
- Participation in any other research study involving a non-approved drug or medical device
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01180621
Start Date
September 1 2010
End Date
April 1 2011
Last Update
June 22 2011
Active Locations (4)
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1
ACHIEVE Research, Alberta Children's Hospital
Calgary, Alberta, Canada
2
Vaccine Evaluation Center
Vancouver, British Columbia, Canada
3
Candian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia, Canada
4
McGill University Health Centre - Vaccine Study Centre
Montreal, Quebec, Canada