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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224613
• Other study ID #: SP1002
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2010
• Last updated: June 14, 2011
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2011
• Source: Dalhousie University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Intanza
0.1 mL of Intanza intradermally at visit # 1
• Intanza
0.1 mL of Intanza intradermally at visit #1

Locations

Country	Name	City	State
Canada	Canadian Center for Vaccinology	Halifax	Nova Scotia
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Dalhousie University	IWK Health Centre, Mount Sinai Hospital, Canada, Sanofi Pasteur MSD

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No