Clinical trial NCT01764152: Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02)
Official title: Efficiency in Population of Influenza Vaccination for Seasonal 2012-2013 for Flu Prevention of the Hospitalized Adults: an Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Hospitalized
Keywords: Prevention,
influenza,
adults hospitalized,
vaccines,
Effectiveness
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Sanofi
First posted: 2013-01-09
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated.
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...)
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut National de la Santé Et de la Recherche Médicale
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Odile Launay, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: