Influenza Vaccine Trial for Seniors for 2011-2012

What is this study about?

The purpose of this study is to determine if one of the new seasonal influenza vaccines is more effective or more acceptable than the usual seasonal vaccine.

Who is being asked to participate?

1. People 65 years and older (930 people across Canada, including 126 in Toronto)
2. Willing to be randomly assigned 1 of 3 Health Canada-approved influenza vaccines
3. Willing to have 3 blood samples taken (1 at each visit)
4. Able to attend 3 visits at Mount Sinai Hospital
1. Sept. 6^th to 16^th, 2011
2. Sept. 27^th - Oct. 7^th, 2011
3. Mar. 1^st to 30^th, 2012
5. In generally good health AND
6. Have received an influenza vaccine in the past 2 years

If I agree to participate, what do I need to do?

If you agree to participate in the study you will be asked to:

1. Attend 3 visits at Mount Sinai Hospital - visits are for one of the following periods:
1. Sept. 6^th to 16^th, 2011 (will take 30-60 minutes)
2. Sept. 27^th - Oct. 7^th, 2011 (will take 20-30 minutes)
3. Mar. 1^st to 30^th, 2012 (will take 10-20 minutes)
2. Fill out a short questionnaire & tell us about your health
3. Allow us to take a blood samples at each visit
4. Receive 1 of the 3 flu vaccines (assigned at random/by chance)
5. Fill out a short questionnaire about the vaccine
6. Keep a diary of any symptoms after your vaccine (redness, swelling, etc.)
7. Tell us about any symptoms you have (with 1 telephone call & at your next visits)

How long will the study last?

The study will begin in September 2011 and last until March 2012.

Are there any risks to participating in the study?

The only common side effect usually seen with the seasonal influenza vaccine is pain at the injection site. Some people will experience mild fatigue, headache, body aches, sweating or shivering and a few (about 1/50) will experience red eyes, breathing symptoms and swelling of the face. These symptoms are generally mild and last only a day or two after the vaccination.

Allergic reactions can be serious but occur in less than 1 in 10,000 people. If you are allergic to eggs you will not be offered the vaccine. Influenza vaccines may also be associated with a 1 in a million risk of a neurological disorder with paralysis called Guillain-Barré syndrome. Guillain-Barré Syndrome (GBS) is a form of body paralysis that is usually temporary and can occur after some common infections.

There may be some discomfort and bruising at the site where blood is drawn from your arm. There is a risk of feeling faint, lightheaded or dizzy as well as a rare chance of infection from blood draws.

Who can I contact to find out more?

You can call the main study office at 416-586-4800 ext. 4160 or email us at IDresearch@mtsinai.on.ca . A member of the study staff will talk to you about the study so you can decide whether or not you wish to participate.

For more information, please visit http://www.clinicaltrials.gov/ct2/show/NCT01368796?term=scheifele&rank=8