Incidence, clinical features, and epidemiology of infection due to a novel strain of influenza in health care workers and other healthy adults and their household contacts in Canada (Influenza Cohort Study) - 2009-2010

PURPOSE

The purpose of this study is to:

• describe the number of cases of influenza infection,
• how ill people become with their illness, and,
• whether personal factors such as age or existing chronic conditions make a person more likely to become ill with influenza.,

We are also studying the effects of the virus itself:

• how long it takes from the time one person becomes ill with it until the time another person becomes ill, and
• how long people are capable of passing the virus on to others.

PROCEDURES

If you wish to participate in the study, you will be asked to:

• Complete a web-based baseline household questionnaire (primary contact only). It will take about 2 minutes.
• Complete a baseline personal questionnaire (everyone). It will take about 10 minutes.
• Complete a web-based questionnaire once a week to report any symptoms of acute respiratory illness. It will take about 2-3 minutes to complete the weekly report. Weekly reporting will continue until the first "wave" of infection due to this new strain is over - this may be as long as 26 weeks (all adults).
• If you develop any symptoms of an acute respiratory illness (for instance, stuffy/runny nose, cough or fever), have a nasopharyngeal or nasal swab done, and complete an illness diary daily for duration of the illness. It will take 2 to 5 minutes to complete the illness reports.
• Consider asking other members of your household to participate in this study.
• Consider having a single tube of blood taken at the beginning and end of the study: 1) to measure your antibody level to influenza at the beginning of the study and 2) to test whether or not you get infected with influenza even if you do not have symptoms.
• If you develop influenza, we will ask if you would be willing to participate in a viral shedding study. A separate consent will be provided for that study.

Study Timeline

Timeline Study requirements Visit 1 Consent Baseline household questionnaire (Primary contact) Baseline personal questionnaire Blood sample (if you agree) Every Monday Weekly diary If you develop any symptoms of a cold or influenza Illness diary (daily) NP or nasal swab End of study Blood sample (if you agree)

RISKS

• There may be some nasal discomfort when the nasopharyngeal and nasal swabs are taken.
• If you agree to have your blood drawn, there may be some discomfort and bruising at the site where the blood sample is taken.

BENEFITS

There are no direct benefits to you for participating in this study. It is hoped that your participation will help us assess the epidemiology of the circulating strain of influenza and help us plan for future pandemics.

CONFIDENTIALITY

• If you agree to join this study, the study doctors and their team will collect some personal health information from you.
• All information collected during this study, including your personal health information, will be kept confidential and will not be shared with anyone outside the study unless required by law
• If you develop influenza, the study is required to report the illness to your Medical Officer of Health (this is true of all influenza infections at all times). Staff of your public health unit may contact you to ask some questions about your illness.

PARTICIPATION

Your participation in this study is voluntary.

Study Investigators:

Dr. Allison McGeer, Mount Sinai Hospital, Toronto, Ontario
Dr. Brenda Coleman, Mount Sinai Hospital, Toronto, Ontario
Dr. Natasha Crowcroft, Ontario Agency for Health Protection and Promotion, Toronto
Ms. Karen Green, Mount Sinai Hospital, Toronto, Ontario
Dr. Kevin Katz, North York General Hospital, Toronto, Ontario
Dr. Mark Loeb, Hamilton Health Sciences Centre, Hamilton
Dr. Shelly McNeil Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia
Dr. Matthew Muller, St. Michael's Hospital, Toronto, Ontario
Dr. Andrew Simor, Sunnybrook Health Sciences Centre, Toronto, Ontario