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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Page 1 of 1 (4 locations)

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