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Mount Sinai Hospital is a University of Toronto patient care, teaching, and research centre.
Mount Sinai Hospital is a University of Toronto patient care, teaching, and research centre.

Active surveillance of adverse events following influenza vaccination

Why are we doing this?

The purpose is to provide rapid, active surveillance for the safety of the influenza vaccine.

Who is being asked to participate?

We are asking people from several Canadian hospitals to participate (2 in Vancouver, and others in Toronto, Ottawa, Quebec City, Sherbrooke, and Halifax). We are hoping to enrol more than 10,000 healthcare workers, with about 1,000 from Toronto.

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

If you agree, you will be asked to provide us with an email address and telephone number.

On day 3, 8, and 29 after your vaccination, we will send you an email with a link to an online questionnaire. We will also send you an email with a link to an online questionnaire about 2 weeks before the influenza vaccination campaign next October.

The first email/questionnaire will be made to ensure that your email address works

The questionnaires on day 8 and 29 will assess if you have experienced new health problems since you received the vaccine. We are interested in learning about health problems which have resulted in missed work days or physician consultation. If you don't respond to each email, we will send you a reminder email.

If you have not missed work or seen a doctor, your participation will end. If you have, we will ask you to provide us with a phone number at which we can reach you so that a study nurse can collect information about the illness/event that caused you to miss work or see a doctor. Study staff will enter this information, without your identity, into a national database that will allow public health officials to monitor the types of illness that occur, and potentially allow them to detect any adverse effects of vaccination.

About 2 weeks before the influenza vaccination campaign next season, we will send another questionnaire asking about any symptoms (e.g. headache, vomiting) that you had in the 7 days before you received it. This information will be used as a "baseline" to compare with the proportion of people who have similar symptoms after getting their flu vaccine.

Are there any risks to participating?

There are no known risks or direct benefits to you for participating in this study. We hope that Canadians will benefit from building a more comprehensive surveillance system for vaccine safety.

Who can I contact if I am interested in the study?

We will have staff at the vaccination clinics who will ask if you are interested in helping us. If you aren't asked, you can call the study office at 416-586-4800 ext. 4161 or email us at IDresearch2@mtsinai.on.ca. A member of the study staff will then arrange to talk to you so you can decide whether or not you wish to participate.

Investigators

  • Dr Gaston De Serres, Centre Hospitalier Universitaire de Québec, Québec City
  • Dr Julie Bettinger, BC Children's and Women's Hospital, Vancouver
  • Dr Grant Stiver, Vancouver General Hospital, Vancouver
  • Dr Allison McGeer, Mount Sinai Hospital, Toronto
  • Dr Shelly McNeil, Queen Elizabeth II Health Sciences Centre and IWK Health Centre
  • Dr Ann McCarthy, Ottawa Hospital General Campus

This website has been made possible through an unrestricted educational grant from Pfizer Canada Inc.
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