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

Dalhousie University

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: Intanza

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01224613

SP1002

Details and patient eligibility

About

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

Full 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.

Enrollment

276 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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)