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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine, then placebo | Experimental | 1 injection of trivalent inactivated influenza vaccine, 0.5mL/dose, as approved for use in Canada for season of enrolment followed by 1 injection of normal saline placebo, 0.5mL/dose, 28 days later |
|
| Placebo, then vaccine | Experimental | 1 injection of normal saline placebo, 0.5mL/dose followed by 1 injection of trivalent inactivated influenza vaccine, 0.5mL/dose, as approved for use in Canada for season of enrolment, 28 days later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine | Biological | Licensed trivalent inactivated influenza vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic adverse event | Any systemic adverse event, self-reported | 7 days after each injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison J McGeer, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 16, 2019 | |
| Reset | Sep 18, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 16, 2019 | Sep 18, 2019 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |