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Completed

NCT Number: NCT01764152

Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02)

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

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Key information

Conditions

Adult Hospitalized Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut National de la Santé Et de la Recherche Médicale

Paris, 75654, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

nasopharyngeal sample

Other

The nasopharyngeal sample will be used to find the types and subtypes of influenza virus and other respiratory viruses.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Sanofi

Registry information

Official study title

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

Acronym: FLUVAC EV-02

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2013
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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