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

Fraser Health1 site in 1 country1,000 target enrollmentNovember 2011

ConditionsInfluenza

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Influenza
Sponsor: Fraser Health
Enrollment: 1000
Locations: 1
Primary Endpoint: Vaccine effectiveness against laboratory confirmed influenza illness
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

June 2013

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Fraser Health

Responsible Party

Principal Investigator

Paul VanBuynder

Chief Medical Health Officer

Fraser Health

Eligibility 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

•Known immunodeficiency disorders (including HIV)
•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.
•Administration of immunoglobulins during the study period;

Outcomes

Primary Outcomes

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