Study to Compare Self-administered and Nurse-administered Intradermal Influenza Vaccine
- Conditions
- Influenza
- Interventions
- Biological: Intanza
- Registration Number
- NCT01224613
- Lead Sponsor
- Dalhousie University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intanza - nurse-administered Intanza Nurse-administered intradermal influenza vaccine Intanza - self-administered Intanza Self-administered intradermal influenza vaccine
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (2)
Canadian Center for Vaccinology
🇨🇦Halifax, Nova Scotia, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada