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Effectiveness of Influenza Vaccination Among General Practitioners

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00221676
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 28, 2006
Sponsor:
Collaborators:
Universiteit Antwerpen
Eurogenerics NV
Information provided by:
University Hospital, Antwerp

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).

Condition or disease Intervention/treatment Phase
Influenza Biological: Alfarix Phase 4

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Influenza Vaccination (Alfarix)in Preventing Clinical Influenza Cases Among General Practitioners: Non-Randomized Clinical Trial.
Study Start Date : July 2002
Estimated Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources




Primary Outcome Measures :
  1. number of respiratory tract infections
  2. number of influenza cases defined as a RTI with positive nose and throat swabs
  3. number of influenza cases defined as a RTI with 4-fold IgG titre rise


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:general practitioner with an active practice in Flanders, Belgium -

Exclusion Criteria:other specialists in medicine


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221676


Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Eurogenerics NV
Investigators
Principal Investigator: Barbara Michiels, Dr. University of Antwerp, Department of family medicine

Publications:
ClinicalTrials.gov Identifier: NCT00221676     History of Changes
Other Study ID Numbers: CHA-UA-20011207
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 28, 2006
Last Verified: September 2005

Keywords provided by University Hospital, Antwerp:
influenza vaccine
general practitioner

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases