Influenza
Conditions
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 days post-vaccination. Participants will record information in a memory aid for 7 days including daily temperatures, solicited, unsolicited and general reactions. They will be called on study Day 8 to collect this information. Participants will return 21-24 days later for follow-up serology and review of adverse events.
Interventions
BIOLOGICALIntanza
0.1 mL of Intanza intradermally at visit # 1
Sponsors
IWK Health Centre
MCM Vaccines B.V.
Mount Sinai Hospital, Canada
Dalhousie University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | 21 days post-vaccination | That the immunogenicity of self-administered intradermal 2010/11 seasonal influenza vaccine (Intanza) is non-inferior to that of nurse administered intradermal 2010/11 seasonal influenza vaccine. Specifically, that ratio of increase in geometric mean titres between day 0 and day 21 post-vaccination are greater than 2/3 (i.e. GMT (IDS)/GMT (IDN) \> 0.65). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reactogenicity | 7 days post-vaccination | The reactogenicity of self-administered intradermal 2010/11 seasonal influenza vaccine (Intanza) is not significantly greater than that of nurse administered intradermal 2010/11 seasonal influenza vaccine. |
| Observational | at vaccination | 85% or more of healthy adults can self-administer Intanza successfully; that is, they are willing to self-administer vaccine and successfully administer it, as judged by observation by a trained nurse. |
Countries
Canada
Outcome results
None listed