Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02) (FLUVAC EV-02)
This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised with laboratory-confirmed influenza through a network of hospitals in France
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated. [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764152
|Contact: Odile Launay, PU-PH||+33(0)1 58 41 18 email@example.com|
|Contact: Fabrice Carrat, PU-PH||+33(0)1 44 73 84 firstname.lastname@example.org|
|Institut National de la Santé Et de la Recherche Médicale||Recruiting|
|Paris, France, 75654|
|Contact: Odile Launay, PU-PH +33(0)1 58 41 18 60 email@example.com|
|Contact: Fabrice Carrat, Pu-PH +33(0)1 44 73 84 58 firstname.lastname@example.org|
|Principal Investigator:||Odile Launay, PU-PH||Assistance Publique - Hôpitaux de Paris|