NCT02027233

Clinical Trial to Assess the Influenza Vaccination of the Hospitalized Adults

Efficiency in Population of Influenza Vaccination for Flu Prevention of the Hospitalized Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,173 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised with laboratory-confirmed influenza through a network of hospitals in France. Also, To better understand the burden of other respiratory viruses such as respiratory syncytial virus (RSV) and SARS-CoV-2 in hospitalized adults, we need to describe and quantify the population hospitalized due to theses other respiratory viruses.

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 main objective is to measure the population effectiveness of influenza vaccine in patients hospitalized with virologically confirmed influenza laboratory result during all influenza seasons from 2013/2014 to 2021/2022 in a French hospital network. An interim analysis is provided for each influenza season and a global analysis of all seasons. Each year, we also collect data from other respiratory viruses such as respiratory syncytial virus (RSV) on the hospitalized population. The data for three years confirm that, although RSV is less common than influenza in patients with flu-like symptom (4% of 1452 patients), it is responsible for serious complications at a higher frequency than influenza, especially in the elderly and immunosuppressed patients. To better understand the burden of disease of RSV infection in hospitalized adults, we need to start patients recruitment sooner at the start of the VRS epidemic. With the recent emergence of the COVID-19 pandemic and our participation in European projects within the framework of COVID-19 surveillance, the FLUVAC study is an opportunity to collect additional data in patients hospitalized with a severe acute respiratory illness (SARI) which may be due to respiratory infection with an influenza virus or other respiratory viruses including SARS-CoV-2. We therefore propose to collect clinical (chronic diseases, comorbidities, intensive care), epidemiological and virological data throughout the year in adult patients hospitalized for suspected CO-VID-19. This is a study "case-control" involving a nasopharyngeal sample for all hospitalised patients presenting a SARI within seven days. Cases will be patients RT-PCR positive for influenza. Controls will be patients negative for any influenza virus.

Conditions

• Severe Acute Respiratory Infection

Interventions

Type	Name	Description
OTHER	nasopharyngeal sample	The nasopharyngeal sample will be used to find the types and subtypes of influenza virus and other respiratory viruses (VRS, SARS-CoV-2 and others).

Timeline

• Start date: 2014-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2014-01-06
• Last updated: 2023-10-10

Locations

1 site across 1 country: France