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

August 25, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Efficiency in Population of Influenza Vaccination for Seasonal 2012-2013 for Flu Prevention of the Hospitalized Adults: an Observational Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75654
        • Institut National de la Santé et de la Recherche Médicale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome 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
Time Frame: 6 months
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.
Time Frame: 6 months
6 months
Description of the population hospitalized for ILI (socio-demographic characteristics, risk factors, pattern and duration of hospitalization...)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Sanofi

Investigators

  • Principal Investigator: Odile Launay, PU-PH, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

January 7, 2013

First Posted (Estimated)

January 9, 2013

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C12-57
  • 2012-A01118-35 (Registry Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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