Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02)

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

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-05-31

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

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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.

Conditions

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Adult Hospitalized

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Nasopharyngeal sample

one will be taken nasopharyngeal all patients hospitalized for 24 hours with ILI in the last seven days.

Group Type EXPERIMENTAL

nasopharyngeal sample

Intervention Type OTHER

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

Interventions

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nasopharyngeal sample

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

Intervention Type OTHER

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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No