Back to resultsClinical Trial to Assess the Influenza Vaccination (FLUVAC 02) (FLUVAC EV-02)
Primary Purpose
Adult Hospitalized
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nasopharyngeal sample
Sponsored by
About this trial
This is an interventional prevention trial for Adult Hospitalized focused on measuring Prevention,, influenza,, adults hospitalized,, vaccines,, Effectiveness
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.)
Sites / Locations
- Institut National de la Santé Et de la Recherche MédicaleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nasopharyngeal sample
Arm Description
one will be taken nasopharyngeal all patients hospitalized for 24 hours with ILI in the last seven days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...)
Full Information
NCT ID
NCT01764152
First Posted
December 21, 2012
Last Updated
January 7, 2013
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT01764152
Brief Title
Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02)
Acronym
FLUVAC EV-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
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Hospitalized
Keywords
Prevention,, influenza,, adults hospitalized,, vaccines,, Effectiveness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nasopharyngeal sample
Arm Type
Experimental
Arm Description
one will be taken nasopharyngeal all patients hospitalized for 24 hours with ILI in the last seven days.
Intervention Type
Other
Intervention Name(s)
nasopharyngeal sample
Intervention Description
The nasopharyngeal sample will be used to find the types and subtypes of influenza virus and other respiratory viruses.
Primary Outcome Measure Information:
Title
Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Odile Launay, PU-PH
Phone
+33(0)1 58 41 18 60
Email
odile.launay@cch.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Carrat, PU-PH
Phone
+33(0)1 44 73 84 58
Email
carrat@u707.jussieu.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odile Launay, PU-PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut National de la Santé Et de la Recherche Médicale
City
Paris
ZIP/Postal Code
75654
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odile Launay, PU-PH
Phone
+33(0)1 58 41 18 60
Email
odile.launay@cch.aphp.fr
First Name & Middle Initial & Last Name & Degree
Fabrice Carrat, Pu-PH
Phone
+33(0)1 44 73 84 58
Email
carrat@u707.jussieu.fr
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02)
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