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

A Case-Control Study to Evaluate the Effectiveness of Adjuvanted Trivalent Inactivated Influenza Vaccine in the Elderly Aged ≥65 Years.

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 Overview

• Status: Unknown
• Conditions: Influenza

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
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: PAUL G VAN BUYNDER, MBBS MPH; Phone Number: 6044187497; Email: paul.vanbuynder@fraserhealth.ca

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3T 5H5
      • Recruiting
      • Fraser Health Authority
      • Principal Investigator: PAUL G VAN BUYNDER, MBBS MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Adjuvanted Vaccine Group
Unadjuvanted Vaccine Group
Unvaccinated Elderly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine effectiveness against laboratory confirmed influenza illness	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	Influenza season 2011/12 and 2012/13

Collaborators and Investigators

• Sponsor: Fraser Health
• Collaborators: Novartis Pharmaceuticals
• Investigators: Principal Investigator: PAUL G VAN BUYNDER, MBBS MPH, Fraser Health Authority

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: August 25, 2011
• First Submitted That Met QC Criteria: August 26, 2011
• First Posted (Estimate): August 29, 2011

Study Record Updates

• Last Update Posted (Estimate): October 1, 2012
• Last Update Submitted That Met QC Criteria: September 28, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 2011-071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No