Effectiveness of Influenza Vaccination Among General Practitioners
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Alfarix
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza vaccine, general practitioner
Eligibility Criteria
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
NCT ID
NCT00221676
First Posted
September 13, 2005
Last Updated
November 27, 2006
Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen, Eurogenerics NV
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
Learn more about this trial
Effectiveness of Influenza Vaccination Among General Practitioners
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