NCT01224613

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

June 15, 2011

Status Verified

June 1, 2011

Enrollment Period

2 months

First QC Date

October 14, 2010

Last Update Submit

June 14, 2011

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Reactogenicity

    7 days post-vaccination

  • Observational

    at vaccination

Study Arms (2)

Intanza - self-administered

ACTIVE COMPARATOR

Self-administered intradermal influenza vaccine

Biological: Intanza

Intanza - nurse-administered

ACTIVE COMPARATOR

Nurse-administered intradermal influenza vaccine

Biological: Intanza

Interventions

IntanzaBIOLOGICAL

0.1 mL of Intanza intradermally at visit # 1

Also known as: Influenza Vaccine (Split Virion, Inactivated)
Intanza - self-administered

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Canadian Center for Vaccinology

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5K 1X5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 22902784DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Shelly McNeil, MD

    Canadian Center for Vaccinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 20, 2010

Study Start

November 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

June 15, 2011

Record last verified: 2011-06

Locations

CA(2)