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

• Conditions: Influenza

• Registration Number: NCT01424371
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-29
• Study Start: 2011-11
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-28
• Last Update Posted: 2012-10-01
• Primary Completion: 2013-04
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaccine effectiveness against laboratory confirmed influenza illness	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

Trial Locations

Locations (1)

Fraser Health Authority; 🇨🇦 Surrey, British Columbia, Canada