Effectiveness of Influenza Vaccination Among General Practitioners

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Completed

CT.gov ID

NCT00221676

Collaborator

Universiteit Antwerpen (Other), Eurogenerics NV (Industry)

300

Enrollment

Duration (Months)

Study Details

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).

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 Design

Study Type:

Interventional

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 :

Jul 1, 2002

Study Completion Date :

Jun 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 76 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Exclusion Criteria:other specialists in medicine

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Antwerp
Universiteit Antwerpen
Eurogenerics NV

Investigators

Principal Investigator: Barbara Michiels, Dr., University of Antwerp, Department of family medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00221676

Other Study ID Numbers:

CHA-UA-20011207

First Posted:

Sep 22, 2005

Last Update Posted:

Nov 28, 2006

Last Verified:

Sep 1, 2005

Keywords provided by , ,

influenza vaccine

general practitioner

Additional relevant MeSH terms:

Influenza, Human

Study Results

No Results Posted as of Nov 28, 2006