Study to Compare Self-administered and Nurse-administered Intradermal Influenza Vaccine

A Randomized Controlled Trial To Compare The Immunogenicity Of Self-Administered And Nurse-Administered Intradermal Influenza Vaccine

The purpose of this study is to compare the immunogenicity and reactogenicity of self-administered intradermal influenza vaccine (Intanza)to nurse-administered.

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.

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)