Adult HospitalizedFLUVAC EV-02NCT01764152
Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02)
A study testing nasopharyngeal sample in people with Adult Hospitalized, 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Hospitalized
- What is being tested?
- nasopharyngeal sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to May 2013
- 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 24 hours and presenting an influenza-like illness in the last 7 days before the hospitalization
Who cannot join
- Against indication for influenza vaccination(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
- Patient already hospitalized for respiratory infection during the 2012-2013 influenza season
- Flu already virologically documented in the current influenza season 2012-2013 (RT-PCR, multiple RT-PCR and / or culture.)
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 Seasonal 2012-2013 for Flu Prevention of the Hospitalized Adults: an Observational Study
This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised with laboratory-confirmed influenza through a network of hospitals in France
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 objective is to measure the population effectiveness of influenza vaccine in patients hospitalized with virologically confirmed influenza laboratory during the influenza season 2012/2013 in a French hospitals network. 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.
- Conditions
- Adult Hospitalized
- Being tested
- nasopharyngeal sample
- Keywords
- Prevention,, influenza,, adults hospitalized,, vaccines,, Effectiveness
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Nasopharyngeal sample | Experimental | one will be taken nasopharyngeal all patients hospitalized for 24 hours with ILI in the last seven days. 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: 6 months
Secondary outcomes (3)
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
Measured: 6 months
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.
Measured: 6 months
Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adult HospitalizedStudies 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
- 450 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Odile Launay, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764152
- Sponsor's protocol ID
- C12-57
- Other IDs
- 2012-A01118-35
- Acronym
- FLUVAC EV-02
- Status last verified
- Mar 2025
- First submitted
- 21 Dec 2012
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Puig-Barbera J, Tormos A, Sominina A, Burtseva E, Launay O, Ciblak MA, Natividad-Sancho A, Buigues-Vila A, Martinez-Ubeda S, Mahe C; GIHSN Group. First-year results of the Global Influenza Hospital Surveillance Network: 2012-2013 Northern hemisphere influenza season. BMC Public Health. 2014 Jun 5;14:564. doi: 10.1186/1471-2458-14-564.
PubMed 24903737Puig-Barbera J, Natividad-Sancho A, Launay O, Burtseva E, Ciblak MA, Tormos A, Buigues-Vila A, Martinez-Ubeda S, Sominina A; GIHSN Group. 2012-2013 Seasonal influenza vaccine effectiveness against influenza hospitalizations: results from the global influenza hospital surveillance network. PLoS One. 2014 Jun 19;9(6):e100497. doi: 10.1371/journal.pone.0100497. eCollection 2014.
PubMed 24945510
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency in Population of Influenza Vaccination for Seasonal 2012-2013 for Flu Prevention of the Hospitalized Adults: an Observational Study
- ClinicalTrials.gov ID
- NCT01764152
- Acronym / sponsor ID
- FLUVAC EV-02 / C12-57
- Conditions
- Adult Hospitalized
- Keywords
- Prevention,, influenza,, adults hospitalized,, vaccines,, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Sanofi
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 9 Jan 2013 (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
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 objective is to measure the population effectiveness of influenza vaccine in patients hospitalized with virologically confirmed influenza laboratory during the influenza season 2012/2013 in a French hospitals network. 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 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 sampleone will be taken nasopharyngeal all patients hospitalized for 24 hours with ILI in the last seven days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 year
- Affiliated with social security health insurance
- Written informed consent
- Patients hospitalized for 24 hours and presenting an influenza-like illness in the last 7 days before the hospitalization
Key exclusion criteria (4 listed)
- Against indication for influenza vaccination(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
- Patient already hospitalized for respiratory infection during the 2012-2013 influenza season
- Flu already virologically documented in the current influenza season 2012-2013 (RT-PCR, multiple RT-PCR and / or culture.)
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. | 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: 6 months
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 comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated according to age groups
Time frame: 6 months
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: 6 months
Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...)
Time frame: 6 months
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 2 Sep 2025.
- Results publication: PubMed 24903737Puig-Barbera J, Tormos A, Sominina A, Burtseva E, Launay O, Ciblak MA, Natividad-Sancho A, Buigues-Vila A, Martinez-Ubeda S, Mahe C; GIHSN Group. First-year results of the Global Influenza Hospital Surveillance Network: 2012-2013 Northern hemisphere influenza season. BMC Public Health. 2014 Jun 5;14:564. doi: 10.1186/1471-2458-14-564.
- Results publication: PubMed 24945510Puig-Barbera J, Natividad-Sancho A, Launay O, Burtseva E, Ciblak MA, Tormos A, Buigues-Vila A, Martinez-Ubeda S, Sominina A; GIHSN Group. 2012-2013 Seasonal influenza vaccine effectiveness against influenza hospitalizations: results from the global influenza hospital surveillance network. PLoS One. 2014 Jun 19;9(6):e100497. doi: 10.1371/journal.pone.0100497. eCollection 2014.
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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 Adult Hospitalized, 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 4 inclusion and 4 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 2 Sep 2025. 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: 6 months). 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 NCT01764152, which also lists 2 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 2 Sep 2025.