Clinical trial NCT01224613: Study to Compare Self-administered and Nurse-administered Intradermal Influenza Vaccine
Official title: A Randomized Controlled Trial To Compare The Immunogenicity Of Self-Administered And Nurse-Administered Intradermal Influenza Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Dalhousie University
Sponsor class: OTHER
Collaborators: name: IWK Health Centre
name: MCM Vaccines B.V.
name: Mount Sinai Hospital, Canada
First posted: 2010-10-20
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Immunogenicity
timeFrame: 21 days post-vaccination
Secondary outcomes:
measure: Reactogenicity
timeFrame: 7 days post-vaccination
measure: Observational
timeFrame: at vaccination
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology
state: Nova Scotia
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Canadian Center for Vaccinology
name: Shelly McNeil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coleman BL, McGeer AJ, Halperin SA, Langley JM, Shamout Y, Taddio A, Shah V, McNeil SA. A randomized control trial comparing immunogenicity, safety, and preference for self- versus nurse-administered intradermal influenza vaccine. Vaccine. 2012 Sep 28;30(44):6287-93. doi: 10.1016/j.vaccine.2012.08.006. Epub 2012 Aug 16.