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

This study is currently recruiting participants.
Verified September 2012 by Fraser Health
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Paul VanBuynder, Fraser Health Identifier:
First received: August 25, 2011
Last updated: September 28, 2012
Last verified: September 2012

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


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Case-Control Study to Evaluate the Effectiveness of Adjuvanted Trivalent Inactivated Influenza Vaccine in the Elderly Aged ≥65 Years.

Resource links provided by NLM:

Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • Vaccine effectiveness against laboratory confirmed influenza illness [ Time Frame: Influenza season 2011/12 and 2012/13 ] [ Designated as safety issue: No ]
    Evaluation of the effectiveness of an adjuvanted TIV in the elderly aged ≥65 years, through the reduction in relative risk of microbiologically confirmed influenza illness

Estimated Enrollment: 1000
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Adjuvanted Vaccine Group
Unadjuvanted Vaccine Group
Unvaccinated Elderly

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 illness


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All elderly over 65 years in the lower mainland of British Columbia presenting with an influenza-like-illness


Inclusion Criteria:

1.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 Criteria:

  1. Known immunodeficiency disorders (including HIV)
  2. 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.
  3. Administration of immunoglobulins during the study period;
  Contacts and Locations
Please refer to this study by its identifier: NCT01424371

Contact: PAUL G VAN BUYNDER, MBBS MPH 6044187497

Canada, British Columbia
Fraser Health Authority Recruiting
Surrey, British Columbia, Canada, V3T 5H5
Principal Investigator: PAUL G VAN BUYNDER, MBBS MPH         
Sponsors and Collaborators
Fraser Health
Novartis Pharmaceuticals
Principal Investigator: PAUL G VAN BUYNDER, MBBS MPH Fraser Health Authority
  More Information

No publications provided

Responsible Party: Paul VanBuynder, Chief Medical Health Officer, Fraser Health Identifier: NCT01424371     History of Changes
Other Study ID Numbers: 2011-071
Study First Received: August 25, 2011
Last Updated: September 28, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases processed this record on April 17, 2014