Clinical Trial to Assess the Influenza Vaccination for Seasonal 2013-2016 (FLUVAC EV-03)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Efficiency in Population of Influenza Vaccination for Seasonal 2013-2016 for Flu Prevention of the Hospitalized Adults|
- Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated. [ Time Frame: 3 years ]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: 3 years ]
- 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: 3 years ]
- Description of the population hospitalized for Influenza-like syndrome (socio-demographic, risk factors, pattern and duration of hospitalization) [ Time Frame: 3 years ]
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Nasopharyngeal sample
Rapid completion of nasopharyngeal within 24 hours after hospitalization without exceeding 7 days after the onset
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 3 influenza seasons 2013/2014, 2014/2015 and 2015/2016 in a French hospital network. An interim analysis is provided for each influenza season and an overall analysis of 3 seasons.
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: NCT02027233
|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|
|Principal Investigator:||Odile Launay, PU-PH||Assistance Publique - Hôpitaux de Paris|