Influenza Vaccine Safety and Effectiveness in Healthcare Providers

NCT01282177 | Completed

• 1 other identifier: 114142
• Study Type: observational
• Target: 1,143
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Influenza

Keywords

surveillance, safety , tolerability , vaccine

Outcome Measures

Primary Outcomes (1)

• Assessment of the safety and tolerability of seasonal and pandemic influenza vaccine among a cohort of HCP

  Health care providers will receive automated email reminders with a link to report any changes in their health within 4 weeks of vaccination.

  October to April each year

Secondary Outcomes (1)

• To validate published ILI case definitions in a cohort of HCP

  October to April each year

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• )18-69 years old, inclusive, as of Sept. 1 on the year of enrolment; 2)understand the study, agree to its provisions, and give written informed consent to participate; 3)available for follow-up for at least 1 influenza season 4)have convenient access to a computer with internet access and basic skills for use of the internet; 5)employed full-or part -time (\> 8 hours/week) in an acute care hospital (in any occupation) or, if a physician or midwife, working at least 8 hours per week in an acute care hospital.

You may not qualify if:

• planning to spend more than two consecutive weeks outside of Canada during the winter study period (Oct. 15- Apr. 15);
• received an immunoglobulin within 6 months of study entry;
• planning to take leave from work for more than two consecutive weeks during the winter study period (e.g. maternity or medical leave);
• participating in a trial that would result in receipt of an investigational medication during the study period

Sponsors & Collaborators

• Dalhousie University: lead
• PHAC/CIHR Influenza Research Network: collaborator

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Shelly A McNeil, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Allison McGeer, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Anne McCarthy, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

• Mark Loeb, MD

  Hamilton Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Grant Stiver, MD

  Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

• Brenda Coleman, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 24, 2011
• Study Start: October 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 19, 2017

Record last verified: 2017-01