FLUVAC EV-03: Clinical Trial to Assess the Influenza Vaccination of the Hospitalized Adults

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT02027233

Collaborator

(none)

2,000

Enrollment

Location

Arm

107

Anticipated Duration (Months)

18.7

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.

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Respiratory Infection	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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 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 Flu Prevention of the Hospitalized Adults

Actual Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 (VRS, SARS-CoV-2 and others).

Arm

Intervention/Treatment

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 (VRS, SARS-CoV-2 and others).

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. [9 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.

Secondary Outcome Measures

Measure of vaccine efficacy in population by age group [9 years]
Measure of vaccine efficacy by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated according to age groups
Measure of vaccine efficacy in population by influenza type/subtype [9 years]
The objective is to compare the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated depending on the subtypes.
Description of the population hospitalized for syndrome acute respiratory infection (SARI) [9 years]
The objective is to : Describe and quantify the influenza hospitalized population and its complications (socio-demographic, risk factors, pattern and duration of hospitalization), Describe and quantify the population hospitalized due to other respiratory viruses (VRS, SARS-CoV-2).

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 at least 24 hours for one of the reasons indicated in Table 1 of protocol
Presence of Influenza-like syndrome before the hospitalization (even if symptoms are not present at the time of inclusion), or less than 48 hours after the hospitalization
Rapid completion of nasopharyngeal sample after hospitalization without exceeding 7 days after the onset of Influenza-like syndrome

Exclusion Criteria:

Realization of nasopharyngeal sampling more than 7 days after the onset of symptoms
Contraindication for influenza vaccine (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
Previously tested positive for any influenza virus in the current season (RT-PCR, multiplex RT-PCR)
Patient under curatorship or under guardianship whose sample was obtained as part of their medical care but not complying with the conditions of Article L1121-8 of the Code de la Santé Publique.
Patient under curatorship or under guardianship whose sample was not obtained as part of their medical care.