Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02)

Study Overview
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Brief Summary
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This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised with laboratory-confirmed influenza through a network of hospitals in France

Detailed Description
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Influenza vaccination strategies aim at protecting high-risk population from severe outcomes. Estimating the effectiveness of seasonal vaccines against influenza related hospitalisation is important to guide these strategies. The objective is to measure the population effectiveness of influenza vaccine in patients hospitalized with virologically confirmed influenza laboratory during the influenza season 2012/2013 in a French hospitals network. This is a study case-control involving a nasopharyngeal sample for all hospitalised patients presenting an influenza-like illness within seven days. Cases will be patients RT-PCR positive for influenza. Controls will be patients negative for any influenza virus.

Official Title
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Efficiency in Population of Influenza Vaccination for Seasonal 2012-2013 for Flu Prevention of the Hospitalized Adults: an Observational Study

Conditions
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Adult Hospitalized

Intervention / Treatment
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* Other: nasopharyngeal sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 year Affiliated with social security health insurance Written informed consent Patients hospitalized for 24 hours and presenting an influenza-like illness in the last 7 days before the hospitalization Exclusion Criteria: Against indication for influenza vaccination(Hypersensitivity to the active substances, to any of the excipients and to trace eg eggs, including ovalbumin, chicken protein) Patients institutionalized without regular community interaction Patient already hospitalized for respiratory infection during the 2012-2013 influenza season Flu already virologically documented in the current influenza season 2012-2013 (RT-PCR, multiple RT-PCR and / or culture.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasopharyngeal sample<br>one will be taken nasopharyngeal all patients hospitalized for 24 hours with ILI in the last seven days. | Other: nasopharyngeal sample<br>* The nasopharyngeal sample will be used to find the types and subtypes of influenza virus and other respiratory viruses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated. | The effectiveness of the vaccine in population will be calculated according to the formula VE = 1 - OR. an interval exact confidence of 95% will be calculated on the point estimate. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated according to age groups |  | 6 months | 
| Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated depending on the subtypes. |  | 6 months | 
| Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention,, influenza,, adults hospitalized,, vaccines,, Effectiveness