Clinical trial NCT02263027: Do Some Healthy Adults Consistently Have Systemic Reactions to Influenza Vaccines?
Official title: Do Some Healthy Adults Consistently Have Systemic Reactions to Trivalent Inactivated Split Virus Influenza Vaccines?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: influenza vaccine
adult
safety
reactogenicity
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 reactions in these workers.

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 non-trivial risk of systemic symptoms occurring in the week after both placebo and vaccine. There is a small population of healthcare workers who report consistent systemic symptoms after split virus vaccination which may occur because a small group of healthy adults have true physical reactions to components of the vaccine or excipients. If this is true, then alternatives - such as the use of subunit vaccines or live attenuated nasal spray vaccines - might be expected to be better tolerated by these people.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Systemic adverse event
timeFrame: 7 days after each injection
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Allison J McGeer, MD
role: PRINCIPAL_INVESTIGATOR
References: