Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02)

Institut National de la Santé Et de la Recherche Médicale, France450 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

450

Conditions

Adult Hospitalized

Interventions

nasopharyngeal sampleOTHER

The nasopharyngeal sample will be used to find the types and subtypes of influenza virus and other respiratory viruses.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Institut National de la Santé Et de la Recherche Médicale

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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.

Time frame: 6 months

Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...)

Time frame: 6 months

Data from ClinicalTrials.gov

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