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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Fraser Health.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases processed this record on February 11, 2016