Severe Acute Respiratory InfectionFLUVAC EV-03NCT02027233
Clinical Trial to Assess the Influenza Vaccination of the Hospitalized Adults
A study testing nasopharyngeal sample in people with Severe Acute Respiratory Infection, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Infection
- What is being tested?
- nasopharyngeal sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,173 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut National de la Santé Et de la Recherche Médicale
Paris, 75654
About this study
Official title: Efficiency in Population of Influenza Vaccination for Flu Prevention of the Hospitalized Adults
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.
Read the 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
- Being tested
- nasopharyngeal sample
- Keywords
- Prevention, Influenza and others respiratory viruses, Adults hospitalized, Vaccines, Effectiveness, surveillance
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal sampleOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Nasopharyngeal sample | Experimental | Rapid completion of nasopharyngeal within 24 hours after hospitalization without exceeding 7 days after the onset Receives: Other: nasopharyngeal sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 years
Secondary outcomes (3)
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
Measured: 9 years
Measure of vaccine efficacy in population by influenza type/subtype
The objective is to compare the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated depending on the subtypes.
Measured: 9 years
Description of the population hospitalized for syndrome acute respiratory infection (SARI)
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).
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,173 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Odile Launay, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027233
- Sponsor's protocol ID
- C13-47
- Other IDs
- 2013-A01204-41
- Acronym
- FLUVAC EV-03
- Status last verified
- Oct 2023
- First submitted
- 12 Dec 2013
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31589554Luque-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.
PubMed 35273311Loubet 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.
PubMed 27105315Loubet 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.
PubMed 32283266Loubet 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.
PubMed 27903461Descamps 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.
PubMed 34446468Benezit 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.
PubMed 32056143
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency in Population of Influenza Vaccination for Flu Prevention of the Hospitalized Adults
- ClinicalTrials.gov ID
- NCT02027233
- Acronym / sponsor ID
- FLUVAC EV-03 / C13-47
- Conditions
- Severe Acute Respiratory Infection
- Keywords
- Prevention, Influenza and others respiratory viruses, Adults hospitalized, Vaccines, Effectiveness, surveillance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,173 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Jan 2014 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasopharyngeal sample | Experimental | Other: nasopharyngeal sampleRapid completion of nasopharyngeal within 24 hours after hospitalization without exceeding 7 days after the onset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasopharyngeal sampleThe nasopharyngeal sample will be used to find the types and subtypes of influenza virus and other respiratory viruses (VRS, SARS-CoV-2 and others). | Other | Nasopharyngeal sample |
Primary outcome
Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated.
Time frame: 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.
3 secondary outcomes
Measure of vaccine efficacy in population by age group
Time frame: 9 years
Measure of vaccine efficacy in population by influenza type/subtype
Time frame: 9 years
Description of the population hospitalized for syndrome acute respiratory infection (SARI)
Time frame: 9 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Results publication: PubMed 31589554Tubiana 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.
- Results publication: PubMed 35273311Luque-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.
- Results publication: PubMed 27105315Loubet 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.
- Results publication: PubMed 32283266Loubet 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.
- Results publication: PubMed 27903461Loubet 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.
- Results publication: PubMed 34446468Descamps 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.
- Results publication: PubMed 32056143Benezit 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odile Launay, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasopharyngeal sample in people with Severe Acute Respiratory Infection, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated. (time frame: 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02027233, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.