Status:

UNKNOWN

Adjuvanted Influenza Vaccine Effectiveness in the Elderly (65+Yrs)

Lead Sponsor:

Fraser Health

Collaborating Sponsors:

Novartis Pharmaceuticals

Conditions:

Influenza

Eligibility:

All Genders

65+ years

Brief Summary

This study explores the hypothesis that the use of an adjuvanted influenza vaccine in the elderly will produce greater vaccine effectiveness in their group.

Detailed Description

To evaluate the effectiveness of adjuvanted trivalent inactivated influenza vaccine in the elderly (aged ≥ 65 years) through the reduction in relative risk of microbiologically confirmed influenza ill...

Eligibility Criteria

Inclusion

  • Elderly tested for influenza as part of routine clinical care in the Lower Mainland and on Vancouver Island during the influenza season.
  • Cases: Proven influenza diagnosed on naso-pharyngeal swab via PCR Controls: Elderly with influenza-like-illness testing negative for influenza during the influenza season.

Exclusion

  • Known immunodeficiency disorders (including HIV)
  • Current or recent (within 90 days prior to first dose of influenza vaccine) immunosuppressive treatment including chronic oral steroids (1mg/kg for \> 4 weeks), cytotoxic chemotherapy, radiation therapy, other immunosuppressive drug and biologic agents Note: Use of topical or inhalant corticosteroids is acceptable.
  • Administration of immunoglobulins during the study period;

Key Trial Info

Start Date :

November 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 1 2013

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT01424371

Start Date

November 1 2011

End Date

June 1 2013

Last Update

October 1 2012

Active Locations (1)

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1

Fraser Health Authority

Surrey, British Columbia, Canada, V3T 5H5