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OpenTrials
Completed

NCT Number: NCT00221676

Effectiveness of Influenza Vaccination Among General Practitioners

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).

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

25 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

general practitioner with an active practice in Flanders, Belgium -

Exclusion criteria

other specialists in medicine

-

Treatment and study plan

Alfarix

Biological

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Eurogenerics NV
  • Universiteit Antwerpen

Registry information

Official study title

Effectiveness of Influenza Vaccination (Alfarix)in Preventing Clinical Influenza Cases Among General Practitioners: Non-Randomized Clinical Trial.

Important dates

Study start
2002
Study completion
2004
First posted
Sep 22, 2005
Registry last updated
Nov 28, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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