Effectiveness of Influenza Vaccination Among General Practitioners

NCT ID: NCT00221676

Last Updated: 2006-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2004-06-30

Brief Summary

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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

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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

Conditions

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Influenza

Keywords

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influenza vaccine general practitioner

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Alfarix

Intervention Type BIOLOGICAL

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

25 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role collaborator

Eurogenerics NV

INDUSTRY

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role lead

Principal Investigators

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Barbara Michiels, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Antwerp, Department of family medicine

References

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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.

Reference Type RESULT
PMID: 16831228 (View on PubMed)

Other Identifiers

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CHA-UA-20011207

Identifier Type: -

Identifier Source: org_study_id