Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02)

Not Applicable

Completed

• Conditions: Adult Hospitalized
• Interventions: Other: nasopharyngeal sample

• Registration Number: NCT01764152
• Lead Sponsor: 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

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nasopharyngeal sample	nasopharyngeal sample	one will be taken nasopharyngeal all patients hospitalized for 24 hours with ILI in the last seven days.

Primary Outcome Measures

Name	Time	Method
Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated.	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

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

Trial Locations

Locations (1)

Institut National de la Santé Et de la Recherche Médicale; 🇫🇷 Paris, France