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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Intanza; Biological: Intanza

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.

• Study Type: Interventional
• Enrollment (Anticipated): 276
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Canadian Center for Vaccinology
  • Ontario
    • Toronto, Ontario, Canada, M5K 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intanza - self-administered; Self-administered intradermal influenza vaccine	Biological: Intanza; 0.1 mL of Intanza intradermally at visit # 1; Other Names: Influenza Vaccine (Split Virion, Inactivated); Biological: Intanza; 0.1 mL of Intanza intradermally at visit #1; Other Names: Influenza Vaccine (Split Virion, Inactivated)
Active Comparator: Intanza - nurse-administered; Nurse-administered intradermal influenza vaccine	Biological: Intanza; 0.1 mL of Intanza intradermally at visit # 1; Other Names: Influenza Vaccine (Split Virion, Inactivated); Biological: Intanza; 0.1 mL of Intanza intradermally at visit #1; Other Names: Influenza Vaccine (Split Virion, Inactivated)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity	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).	21 days post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reactogenicity	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.	7 days post-vaccination
Observational	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.	at vaccination

Collaborators and Investigators

• Sponsor: Dalhousie University
• Collaborators: Mount Sinai Hospital, Canada; IWK Health Centre; MCM Vaccines B.V.
• Investigators: Principal Investigator: Shelly McNeil, MD, Canadian Center for Vaccinology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: October 14, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (Estimate): October 20, 2010

Study Record Updates

• Last Update Posted (Estimate): June 15, 2011
• Last Update Submitted That Met QC Criteria: June 14, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: SP1002