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NCT00221676 Clinical Trial

Effectiveness of Influenza Vaccination Among General Practitioners

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00221676
Other study ID # CHA-UA-20011207
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated November 27, 2006
Start date July 2002
Est. completion date June 2004

Study information
Verified date September 2005
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Interventional

Clinical Trial 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).

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

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 76 Years
Eligibility Inclusion Criteria:general practitioner with an active practice in Flanders, Belgium -

Exclusion Criteria:other specialists in medicine

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Alfarix

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Antwerp Eurogenerics NV, Universiteit Antwerpen

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary number of respiratory tract infections
Primary number of influenza cases defined as a RTI with positive nose and throat swabs
Primary number of influenza cases defined as a RTI with 4-fold IgG titre rise
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