Influenza Vaccine Safety and Effectiveness in Healthcare Providers
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      The overall objective of this study is to provide ongoing assessment of the safety and
      effectiveness of seasonal and pandemic H1N1 vaccines in the prevention of ILI (influenza like
      illness), ILI-associated work absenteeism, and laboratory-confirmed influenza in a cohort of
      Canadian HCP (Health care providers). Given the uncertainties around the timing of the
      provision of seasonal influenza immunization to HCP for the 2009/10 influenza season, this
      study will focus on evaluation of safety and effectiveness of pandemic influenza immunization
      in Year 1 and evaluation of all recommended influenza vaccines in Years 2 and 3.
    

Detailed description: 
      Participants in Year 1 (2009/10) will be recruited beginning Oct. 1 through the end of the
      pandemic H1N1 influenza immunization campaign.

      Participants will be followed from the day of vaccination until the end of the influenza
      season approximately Oct-April for each season.

      At the initial visit, participants will have 1 tube of blood (10cc) collected at the time of
      enrolment to determine baseline antibody titres against pandemic H1N1 and the influenza
      strains in the past and current year's seasonal influenza vaccines.

      Participants will receive automated email reminders with links to follow-up web-based
      questionnaires at weekly intervals following the completion of the baseline survey and until
      the end of the influenza season.

      If a participant reports a respiratory illness, they will receive a follow-up questionnaire
      asking details of the illness including the occurrence of respiratory illness and associated
      symptoms, contact with patients or household members that had respiratory illness,
      respiratory symptom-related healthcare utilization, prescription or over-the-counter products
      used for treatment of the respiratory illness, and number of days of work missed due to
      respiratory illness or worked with symptomatic respiratory tract infection. An email will be
      sent to each participant every Monday morning during the season reminding the participant to
      complete their weekly diary and report and send in their nasal swab if they have symptoms of
      an acute respiratory illness.

      At the initial visit participants will be taught how to collect their nasal swab and will
      practice doing their own swab in the presence of the study nurse/research associate.
      Participants will be instructed to collect a nasal swab and return the swabs as soon as
      possible after onset of ILI or respiratory illness (target < 48h after onset). Participants
      will be asked to collect the swab if they develop symptoms compatible with a viral
      respiratory tract infection (fever without an apparent source OR new symptoms with at least 2
      of the following -cough, runny/stuffy nose, sneezing, sore/scratchy throat, hoarseness,
      malaise, myalgia, headache, fatigue OR one local symptom (runny/stuffy nose, sneezing,
      sore/scratchy throat, hoarseness, cough) plus one systemic symptom (fever, malaise, myalgia,
      headache, fatigue). If they prefer, a nasopharyngeal swab will be collected by a member of
      the study team as soon as possible after the onset of symptoms.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A cohort of adult HCP will be offered the opportunity to participate in this surveillance
        study at Influenza vaccination clinics in their health care facility
      
Keywords: surveillance, safety , tolerability , vaccine