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

This study is currently recruiting participants.
Verified September 2012 by Fraser Health
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Paul VanBuynder, Fraser Health
ClinicalTrials.gov Identifier:
NCT01424371
First received: August 25, 2011
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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
Influenza

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)
Groups/Cohorts
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

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01424371

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

Locations
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
Investigators
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
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on April 17, 2014