Adult Hospitalized
Conditions
Keywords
Prevention,, influenza,, adults hospitalized,, vaccines,, Effectiveness
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.
Interventions
The nasopharyngeal sample will be used to find the types and subtypes of influenza virus and other respiratory viruses.
Sponsors
Sanofi
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated. | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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. | 6 months |
| Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...) | 6 months |
Countries
France
Outcome results
None listed