Clinical Trial to Assess the Influenza Vaccination for Seasonal 2013-2016 (FLUVAC EV-03)
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|ClinicalTrials.gov Identifier: NCT02027233|
Recruitment Status : Unknown
Verified February 2016 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Recruiting
First Posted : January 6, 2014
Last Update Posted : February 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Influenza-like Illness||Other: nasopharyngeal sample||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficiency in Population of Influenza Vaccination for Seasonal 2013-2016 for Flu Prevention of the Hospitalized Adults|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||May 2016|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027233
|Contact: Odile Launay, PU-PH||: +33(0)1 58 41 18 firstname.lastname@example.org|
|Contact: Fabrice Carrat, PU-PH||+33(0)1 44 73 84 email@example.com|
|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|