NCT01424371

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 1, 2012

Status Verified

September 1, 2012

Enrollment Period

1.4 years

First QC Date

August 25, 2011

Last Update Submit

September 28, 2012

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Adjuvanted Vaccine Group

Unadjuvanted Vaccine Group

Unvaccinated Elderly

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All elderly over 65 years in the lower mainland of British Columbia presenting with an influenza-like-illness

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fraser Health Authority

Surrey, British Columbia, V3T 5H5, Canada

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • PAUL G VAN BUYNDER, MBBS MPH

    Fraser Health Authority

    PRINCIPAL INVESTIGATOR

Central Study Contacts

PAUL G VAN BUYNDER, MBBS MPH

CONTACT

6044187497paul.vanbuynder@fraserhealth.ca

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Medical Health Officer

Study Record Dates

First Submitted

August 25, 2011

First Posted

August 29, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

October 1, 2012

Record last verified: 2012-09

Locations

CA(1)