Status:
COMPLETED
Do Some Healthy Adults Consistently Have Systemic Reactions to Influenza Vaccines?
Lead Sponsor:
Mount Sinai Hospital, Canada
Conditions:
Influenza
Eligibility:
All Genders
18-69 years
Phase:
PHASE4
Brief Summary
This study will recruit 35 healthcare workers who had systemic reactions to influenza vaccine the last 2 times they were vaccinated, to ask whether influenza vaccine is indeed associated with systemic...
Detailed Description
Randomized controlled trials of split virus vaccines in healthy adults have not been able to detect an increase in systemic adverse events compared to control vaccination. These trials do identify a n...
Eligibility Criteria
Inclusion
- Employed or volunteer in a healthcare facility or an ambulatory care setting providing healthcare
- By self report, have had 2 or more doses of trivalent inactivated influenza vaccine (TIIV) in the last 15 years, and after at least the last 2 vaccine doses have had the same systemic adverse event in the 7 days after vaccination, including: fever, chills, myalgia, arthralgia, fatigue, headache, or insomnia;
- Consent to the study, including two injections one month apart, with one being placebo and one a dose of TIIV;
Exclusion
- Has a contraindication to TIIV (previous allergic reaction to a dose of vaccine, or Guillain Barre syndrome with onset within 6 weeks of vaccination);
- Has previously received a dose of TIIV for the current influenza season.
- Receipt of another vaccine, or initiation of new medication within 7 days of the study injection (participant may enter the study as long as the gap between other vaccine/initiation of new medication is \>7 days);
- Moderate or severe acute illness or active infection or fever (temperature ≥37.8oC) on the day a dose of study medication due (participant may receive injection 48 hours after symptoms have resolved and body temperature has returned to normal without the use of antipyretics.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02263027
Start Date
October 1 2014
End Date
January 1 2016
Last Update
January 14 2016
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5