Status:
COMPLETED
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Conditions:
HIV Infections
H1N1 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 HIV-infected adults. The study will enroll 150 adults (ages 20-59 year...
Detailed Description
During the first wave of the H1N12009 pandemic in Canada, adults with immune deficiency were more likely to die with severe infections than were other Canadians. Of 76 deaths attributed to date to thi...
Eligibility Criteria
Inclusion
- Laboratory-confirmed HIV
- Written informed consent
- Adults 20-59 years 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
- Chronic illness
- Previous lab-confirmed H1N12009 infection
- Receipt of any non-study H1N12009 or Seasonal Influenza vaccine for 2009/10
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01002040
Start Date
February 1 2010
End Date
August 1 2010
Last Update
April 15 2015
Active Locations (4)
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1
Dalhousie University
Halifax, Nova Scotia, Canada
2
University of Ottawa / Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
3
University of Toronto
Toronto, Ontario, Canada
4
McGill University
Montreal, Quebec, Canada