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Trial record 1 of 1 for:    FLUVAC EV-03
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Clinical Trial to Assess the Influenza Vaccination for Seasonal 2013-2016 (FLUVAC EV-03)

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2016 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Collaborator:
MCM Vaccines B.V.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT02027233
First received: December 12, 2013
Last updated: February 24, 2016
Last verified: February 2016
  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
Influenza-like Illness Other: nasopharyngeal sample

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficiency in Population of Influenza Vaccination for Seasonal 2013-2016 for Flu Prevention of the Hospitalized Adults

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: 3 years ]
    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: 3 years ]
  • 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: 3 years ]
  • Description of the population hospitalized for Influenza-like syndrome (socio-demographic, risk factors, pattern and duration of hospitalization) [ Time Frame: 3 years ]

Estimated Enrollment: 2000
Study Start Date: January 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nasopharyngeal sample
Rapid completion of nasopharyngeal within 24 hours after hospitalization without exceeding 7 days after the onset
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 3 influenza seasons 2013/2014, 2014/2015 and 2015/2016 in a French hospital network. An interim analysis is provided for each influenza season and an overall analysis of 3 seasons.

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   (Adult, Senior)
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 at least 24 hours for one of the reasons indicated in Table 1 of protocol
  • Presence of Influenza-like syndrome in the last 7 days before the hospitalization (even if symptoms are not present at the time of inclusion)
  • Rapid completion of nasopharyngeal sample within 24 hours after hospitalization without exceeding 7 days after the onset of Influenza-like syndrome

Exclusion Criteria:

  • Realisation of nasopharyngeal sample after 7 days since the onset of Influenza-like syndrome
  • 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
  • Flu already virologically documented in the current influenza season on going(RT-PCR, multiple RT-PCR and / or culture.)
  • Onset of Influenza-like syndrome after hospitalization
  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: NCT02027233

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
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
MCM Vaccines B.V.
Investigators
Principal Investigator: Odile Launay, PU-PH Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02027233     History of Changes
Other Study ID Numbers: C13-47
2013-A01204-41 ( Registry Identifier: IDRCB )
Study First Received: December 12, 2013
Last Updated: February 24, 2016

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

ClinicalTrials.gov processed this record on August 23, 2017