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Effectiveness of Influenza Vaccination Among General Practitioners

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Alfarix
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza vaccine, general practitioner

Eligibility Criteria

25 Years - 76 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:general practitioner with an active practice in Flanders, Belgium - Exclusion Criteria:other specialists in medicine -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    number of respiratory tract infections
    number of influenza cases defined as a RTI with positive nose and throat swabs
    number of influenza cases defined as a RTI with 4-fold IgG titre rise

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    November 27, 2006
    Sponsor
    University Hospital, Antwerp
    Collaborators
    Universiteit Antwerpen, Eurogenerics NV
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00221676
    Brief Title
    Effectiveness of Influenza Vaccination Among General Practitioners
    Official Title
    Effectiveness of Influenza Vaccination (Alfarix)in Preventing Clinical Influenza Cases Among General Practitioners: Non-Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital, Antwerp
    Collaborators
    Universiteit Antwerpen, Eurogenerics NV

    4. Oversight

    5. Study Description

    Brief Summary
    Besides the personal protection, influenza vaccination especially needs to prevent transmission of influenza between GPs and their patients. The question remains if the vaccine is adding substantial benefit to the natural acquired immunity of GPs. Doubts are raised if an inactivated vaccine, which elicit especially humoral immune response, can give enough protection against virus replication and subclinical influenza infections. Until now no effectiveness studies of influenza vaccination were performed among GPs. This study will assess the effectiveness of an inactivated influenza vaccine in GPs against clinical respiratory tract infections and more particular against influenza cases with influenza positive nose and throat swabs (diagnosed by RT-PCR).
    Detailed Description
    Two important aspects emerge when considering influenza vaccination of general practitioners as advocated by many guidelines. Besides the personal protection the vaccine especially needs to prevent transmission of influenza between GPs and their patients. In long-term elderly hospitals a possible benefit of influenza vaccination of the healthcare workers was noticed in reducing mortality among the elderly. But this specific situation is not fully transmissible to the general practice. GPs, having yearly close contact with several influenza cases, built up a high basic immunity and probably only suffer from minor symptoms. The question remains if the vaccine is adding substantial benefit to this natural acquired immunity. In addition doubts are raised in the literature if an inactivated vaccine, which elicit especially humoral immune response, can give enough protection against virus replication and subclinical influenza infections. Until now no effectiveness studies of influenza vaccination were performed among GPs. High time to look more closer to these issues. Comparisons: the effectiveness of an inactivated influenza vaccine compared with no vaccine in GPs against clinical respiratory tract infections and more particular against influenza cases with influenza positive nose and throat swabs (diagnosed by RT-PCR), besides serological defined influenza cases and taking important independent variables into account

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza
    Keywords
    influenza vaccine, general practitioner

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    300 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Alfarix
    Primary Outcome Measure Information:
    Title
    number of respiratory tract infections
    Title
    number of influenza cases defined as a RTI with positive nose and throat swabs
    Title
    number of influenza cases defined as a RTI with 4-fold IgG titre rise

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    76 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria:general practitioner with an active practice in Flanders, Belgium - Exclusion Criteria:other specialists in medicine -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Barbara Michiels, Dr.
    Organizational Affiliation
    University of Antwerp, Department of family medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16831228
    Citation
    Michiels B, Philips H, Coenen S, Yane F, Steinhauser T, Stuyck S, Denekens J, Van Royen P. The effect of giving influenza vaccination to general practitioners: a controlled trial [NCT00221676]. BMC Med. 2006 Jul 10;4:17. doi: 10.1186/1741-7015-4-17.
    Results Reference
    result

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