Status:
COMPLETED
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults
Lead Sponsor:
David Scheifele
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
PHAC/CIHR Influenza Research Network
Conditions:
H1N1/2009 Influenza
Eligibility:
All Genders
6-59 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 aboriginal children and adults. The study will enroll 200 healthy adul...
Detailed Description
During the first wave of the H1N12009 pandemic in Canada, persons of aboriginal background were more often hospitalized with severe infections than were other Canadians. Among First Nations members th...
Eligibility Criteria
Inclusion
- Good general health
- Written informed consent provided by or for the subject
- Aboriginal ethnicity (First Nations, Metis or Inuit)
- Adults 20-59 years of age
- Children 6-35 months of age
Exclusion
- Allergies to eggs, thimerosal or gentamicin sulphate
- Life-threatening reaction to previous Flu vaccine
- Bleeding disorder
- Pregnancy
- Receipt of blood or blood products in past 3 months
- Compromised immune system
- Chronic illness
- Previous lab-confirmed H1N1/2009 infection
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01001026
Start Date
November 1 2009
End Date
February 1 2010
Last Update
April 10 2015
Active Locations (5)
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1
Calgary Health Services and Alberta Children's Hospital
Calgary, Alberta, Canada
2
Capital Health District, Alberta Health Services
Edmonton, Alberta, Canada
3
Child and Family Research Center
Vancouver, British Columbia, Canada
4
Vaccine Evaluation Center, University of British Columbia
Vancouver, British Columbia, Canada