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Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02) (FLUVAC EV-02)

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ClinicalTrials.gov Identifier: NCT01764152
Recruitment Status : Unknown
Verified December 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : January 9, 2013
Last Update Posted : January 9, 2013
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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

Condition or disease Intervention/treatment Phase
Adult Hospitalized Other: nasopharyngeal sample Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficiency in Population of Influenza Vaccination for Seasonal 2012-2013 for Flu Prevention of the Hospitalized Adults: an Observational Study
Study Start Date : December 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Nasopharyngeal sample
one will be taken nasopharyngeal all patients hospitalized for 24 hours with ILI in the last seven days.
Other: nasopharyngeal sample
The nasopharyngeal sample will be used to find the types and subtypes of influenza virus and other respiratory viruses.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...) [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764152


Contacts
Contact: Odile Launay, PU-PH +33(0)1 58 41 18 60 odile.launay@cch.aphp.fr
Contact: Fabrice Carrat, PU-PH +33(0)1 44 73 84 58 carrat@u707.jussieu.fr

Locations
France
Institut National de la Santé Et de la Recherche Médicale Recruiting
Paris, France, 75654
Contact: Odile Launay, PU-PH    +33(0)1 58 41 18 60    odile.launay@cch.aphp.fr   
Contact: Fabrice Carrat, Pu-PH    +33(0)1 44 73 84 58    carrat@u707.jussieu.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Sanofi
Investigators
Principal Investigator: Odile Launay, PU-PH Assistance Publique - Hôpitaux de Paris

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01764152     History of Changes
Other Study ID Numbers: C12-57
2012-A01118-35 ( Registry Identifier: IDRCB )
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: January 9, 2013
Last Verified: December 2012

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Prevention,
influenza,
adults hospitalized,
vaccines,
Effectiveness

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases