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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01764152
First received: December 21, 2012
Last updated: January 7, 2013
Last verified: December 2012
  Purpose

This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised with laboratory-confirmed influenza through a network of hospitals in France


Condition Intervention
Adult Hospitalized
Other: nasopharyngeal sample

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: December 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 21, 2012
Last Updated: January 7, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on November 20, 2014