Adjuvanted Influenza Vaccine Effectiveness in the Elderly (65+Yrs)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Fraser Health.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Paul VanBuynder, Fraser Health
First received: August 25, 2011
Last updated: September 28, 2012
Last verified: September 2012
This study explores the hypothesis that the use of an adjuvanted influenza vaccine in the elderly will produce greater vaccine effectiveness in their group.
||Observational Model: Case Control
Time Perspective: Prospective
||A Case-Control Study to Evaluate the Effectiveness of Adjuvanted Trivalent Inactivated Influenza Vaccine in the Elderly Aged ≥65 Years.
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
Adjuvanted Vaccine Group
Unadjuvanted Vaccine Group
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
|Ages Eligible for Study:
||65 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
All elderly over 65 years in the lower mainland of British Columbia presenting with an influenza-like-illness
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.
- 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;
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424371
|Fraser Health Authority
|Surrey, British Columbia, Canada, V3T 5H5 |
|Principal Investigator: PAUL G VAN BUYNDER, MBBS MPH |
||PAUL G VAN BUYNDER, MBBS MPH
||Fraser Health Authority
No publications provided
ClinicalTrials.gov processed this record on March 26, 2015
||Paul VanBuynder, Chief Medical Health Officer, Fraser Health
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 25, 2011
||September 28, 2012
||Canada: Ethics Review Committee