Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01204-41 | Registry Identifier | IDRCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasopharyngeal sample | Experimental | Rapid completion of nasopharyngeal within 24 hours after hospitalization without exceeding 7 days after the onset |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasopharyngeal sample | Other | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated. | 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. | 9 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of vaccine efficacy in population by age group | Measure of vaccine efficacy by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated according to age groups | 9 years |
| Measure of vaccine efficacy in population by influenza type/subtype |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Odile Launay, PU-PH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut National de la Santé Et de la Recherche Médicale | Paris | 75654 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31589554 | Result | Tubiana S, Launay O, Galtier F, Tattevin P, Postil D, Vanhems P, Lenzi N, Verger P, Duval X. Attitudes, knowledge, and willingness to be vaccinated against seasonal influenza among patients hospitalized with influenza-like-illness: impact of diagnostic testing. Hum Vaccin Immunother. 2020 Apr 2;16(4):851-857. doi: 10.1080/21645515.2019.1674598. Epub 2020 Mar 2. | |
| 35273311 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective is to compare the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated depending on the subtypes. |
| 9 years |
| Description of the population hospitalized for syndrome acute respiratory infection (SARI) | The objective is to :
| 9 years |
| Luque-Paz D, Tattevin P, Loubet P, Benezit F, Thibault V, Laine F, Vanhems P, Amour S, Lina B, Duval X, L'Honneur AS, Fidouh N, Vallejo C, Alain S, Galtier F, Foulongne V, Lagathu G, Lenzi N, Lesieur Z, Launay O, Jouneau S; FLUVAC Study Group. Chronic use of inhaled corticosteroids in patients admitted for respiratory virus infections: a 6-year prospective multicenter study. Sci Rep. 2022 Mar 10;12(1):4199. doi: 10.1038/s41598-022-08089-0. |
| 27105315 | Result | Loubet P, Samih-Lenzi N, Galtier F, Vanhems P, Loulergue P, Duval X, Jouneau S, Postil D, Rogez S, Valette M, Merle C, Regis C, Costa Y, Lesieur Z, Tattevin P, Lina B, Carrat F, Launay O; FLUVAC Study Group. Factors associated with poor outcomes among adults hospitalized for influenza in France: A three-year prospective multicenter study. J Clin Virol. 2016 Jun;79:68-73. doi: 10.1016/j.jcv.2016.04.005. Epub 2016 Apr 12. |
| 32283266 | Result | Loubet P, Mathieu P, Lenzi N, Galtier F, Laine F, Lesieur Z, Vanhems P, Duval X, Postil D, Amour S, Rogez S, Lagathu G, L'Honneur AS, Foulongne V, Houhou N, Lina B, Carrat F, Launay O; Fluvac study group. Characteristics of human metapneumovirus infection in adults hospitalized for community-acquired influenza-like illness in France, 2012-2018: a retrospective observational study. Clin Microbiol Infect. 2021 Jan;27(1):127.e1-127.e6. doi: 10.1016/j.cmi.2020.04.005. Epub 2020 Apr 10. |
| 27903461 | Result | Loubet P, Lenzi N, Valette M, Foulongne V, Krivine A, Houhou N, Lagathu G, Rogez S, Alain S, Duval X, Galtier F, Postil D, Tattevin P, Vanhems P, Carrat F, Lina B, Launay O; FLUVAC Study Group. Clinical characteristics and outcome of respiratory syncytial virus infection among adults hospitalized with influenza-like illness in France. Clin Microbiol Infect. 2017 Apr;23(4):253-259. doi: 10.1016/j.cmi.2016.11.014. Epub 2016 Nov 27. |
| 34446468 | Result | Descamps A, Lenzi N, Galtier F, Laine F, Lesieur Z, Vanhems P, Amour S, L'Honneur AS, Fidouh N, Foulongne V, Lagathu G, Duval X, Merle C, Lina B, Carrat F, Launay O, Loubet P; FLUVAC study group. In-hospital and midterm post-discharge complications of adults hospitalised with respiratory syncytial virus infection in France, 2017-2019: an observational study. Eur Respir J. 2022 Mar 3;59(3):2100651. doi: 10.1183/13993003.00651-2021. Print 2022 Mar. |
| 32056143 | Result | Benezit F, Loubet P, Galtier F, Pronier C, Lenzi N, Lesieur Z, Jouneau S, Lagathu G, L'Honneur AS, Foulongne V, Vallejo C, Alain S, Duval X, Houhou N, Costa Y, Vanhems P, Amour S, Carrat F, Lina B, Launay O, Tattevin P; FLUVAC Study Group. Non-influenza respiratory viruses in adult patients admitted with influenza-like illness: a 3-year prospective multicenter study. Infection. 2020 Aug;48(4):489-495. doi: 10.1007/s15010-019-01388-1. Epub 2020 Feb 13. |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |