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Effectiveness of Influenza Vaccination Among General Practitioners

This study has been completed.
Sponsor:
Collaborators:
Universiteit Antwerpen
Eurogenerics NV
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00221676
First received: September 13, 2005
Last updated: November 27, 2006
Last verified: September 2005
History of Changes
  Purpose

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 Intervention Phase
Influenza
 Biological: Alfarix
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of Influenza Vaccination (Alfarix)in Preventing Clinical Influenza Cases Among General Practitioners: Non-Randomized Clinical Trial.

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

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

Estimated Enrollment: 300
Study Start Date: July 2002
Estimated Study Completion Date: June 2004
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

  Eligibility

Ages Eligible for Study:   25 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria:other specialists in medicine

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221676

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

Publications:

ClinicalTrials.gov Identifier: NCT00221676     History of Changes
Other Study ID Numbers: CHA-UA-20011207
Study First Received: September 13, 2005
Last Updated: November 27, 2006
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

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

ClinicalTrials.gov processed this record on May 19, 2013