Status:
COMPLETED
Study to Compare Self-administered and Nurse-administered Intradermal Influenza Vaccine
Lead Sponsor:
Dalhousie University
Collaborating Sponsors:
IWK Health Centre
MCM Vaccines B.V.
Conditions:
Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the immunogenicity and reactogenicity of self-administered intradermal influenza vaccine (Intanza)to nurse-administered.
Detailed Description
Participants will be randomized at visit one to either receive self-administered or nurse-administered intradermal influenza vaccine (Intanza). A blood sample will be taken prior to vaccination and 21...
Eligibility Criteria
Inclusion
- Medically stable persons between age of 18-60
- Available during the trial period and for follow-up
- Able to read, understand, and sign informed consent
- Able to be contacted by telephone for follow-up of adverse events
Exclusion
- Use of experimental vaccines within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the duration of the study.
- Receipt of immunoglobulin or other blood product within 3 months prior to enrollment
- Receipt of other licensed vaccines within the preceding 4 weeks
- History of a severe reaction following influenza vaccination
- Use of cytotoxic therapy or biologic modifiers in the previous 2 years.
- Plans to receive cytotoxic therapy during the study period.
- Concurrent acute moderate to severe illness. (Vaccination will be deferred until recovery. Subjects with mild illnesses with fever ≤37.8ºC orally may be enrolled).
- History of medical disorder associated with immunosuppression (eg. including HIV-infected individuals, transplant recipients)
- History of chronic lung, cardiac, renal or liver disease, which has required hospitalization in the last year.
- Receipt of any high-dose daily systemic corticosteroids (inhaled steroids are acceptable) within two weeks of study entry. High dose is defined as a dose of 20 mg of prednisone daily or its equivalent. Topical steroids are allowed.
- Failure to give written, informed consent
- History of febrile illness (\>37.8ºC orally) within the past 72 hours (immunization may be deferred).
- Known allergy to eggs or other components of vaccine (i.e., thimerosal)
- History of Guillain-Barré Syndrome (GBS)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT01224613
Start Date
November 1 2010
End Date
February 1 2011
Last Update
June 15 2011
Active Locations (2)
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1
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada, B3K 6R8
2
Mount Sinai Hospital
Toronto, Ontario, Canada, M5K 1X5