Status:
COMPLETED
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine
Lead Sponsor:
David Scheifele
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Influenza
H1N1 2009 Influenza
Eligibility:
All Genders
20-59 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in adults when given at the same time or prior to the seasonal influenza ...
Detailed Description
The objectives of this study are two-fold: 1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults, soon after the pandemic vaccine becomes availa...
Eligibility Criteria
Inclusion
- Written informed consent
- Adults 20-59 years of age
Exclusion
- Allergies to eggs, thimerosal, gentamicin sulphate, neomycin
- Life-threatening reaction to previous Flu vaccine
- Bleeding disorder
- Pregnancy
- Receipt of blood or blood products in past 3 months
- Chronic illness
- Compromised immune system
- Previous lab-confirmed H1N12009 infection
- Receipt of H1N12009 vaccine
- Receipt of Seasonal Influenza vaccine since March 2009
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT01000584
Start Date
November 1 2009
End Date
February 1 2010
Last Update
April 10 2015
Active Locations (4)
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1
McMaster University
Hamilton, Ontario, Canada
2
Kingston, Frontenac, Lanark Health Unit
Kingston, Ontario, Canada
3
University of Toronto, Mt Sinai Hospital
Toronto, Ontario, Canada
4
Institut national de sante publique du Quebec
Québec, Quebec, Canada