FLUVAC EV-02: Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02)

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT01764152

Collaborator

Sanofi (Industry)

500

Enrollment

Location

Arm

Duration (Months)

100.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adult Hospitalized	Other: nasopharyngeal sample	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Apr 1, 2013

Anticipated Study Completion Date :

May 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Nasopharyngeal sample

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

Other: nasopharyngeal sample

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

Outcome Measures

Primary Outcome Measures

Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated. [6 months]
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.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)