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

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ClinicalTrials.gov Identifier: NCT01424371
Recruitment Status : Unknown
Verified September 2012 by Paul VanBuynder, Fraser Health.
Recruitment status was:  Recruiting
First Posted : August 29, 2011
Last Update Posted : October 1, 2012
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Paul VanBuynder, Fraser Health

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.

Condition or disease

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

Study Type : Observational
Estimated Enrollment : 1000 participants
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.
Study Start Date : November 2011
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Adjuvanted Vaccine Group
Unadjuvanted Vaccine Group
Unvaccinated Elderly

Primary Outcome Measures :
  1. Vaccine effectiveness against laboratory confirmed influenza illness [ Time Frame: Influenza season 2011/12 and 2012/13 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424371

Contact: PAUL G VAN BUYNDER, MBBS MPH 6044187497 paul.vanbuynder@fraserhealth.ca

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

Responsible Party: Paul VanBuynder, Chief Medical Health Officer, Fraser Health
ClinicalTrials.gov Identifier: NCT01424371     History of Changes
Other Study ID Numbers: 2011-071
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: October 1, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs