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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01424371
• Other study ID #: 2011-071
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2011
• Last updated: September 28, 2012
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: September 2012
• Source: Fraser Health
• Contact: PAUL G VAN BUYNDER, MBBS MPH
• Phone: 6044187497
• Email: paul.vanbuynder[@]fraserhealth.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Locations

Country	Name	City	State
Canada	Fraser Health Authority	Surrey	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Fraser Health	Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No