Clinical Trial to Assess the Influenza Vaccination of the Hospitalized Adults

NCT02027233 | Completed

• 2 other identifiers: C13-472013-A01204-41
• Study Type: interventional
• Target: 6,173
• Locations: 1 country
• Sites: 1

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. Also, To better understand the burden of other respiratory viruses such as respiratory syncytial virus (RSV) and SARS-CoV-2 in hospitalized adults, we need to describe and quantify the population hospitalized due to theses other respiratory viruses.

Conditions

Severe Acute Respiratory Infection

Keywords

Prevention; Influenza and others respiratory viruses; Adults hospitalized; Vaccines; Effectiveness, surveillance

Outcome Measures

Primary Outcomes (1)

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

  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.

  9 years

Secondary Outcomes (3)

• Measure of vaccine efficacy in population by age group

  9 years

• Measure of vaccine efficacy in population by influenza type/subtype

  9 years

• Description of the population hospitalized for syndrome acute respiratory infection (SARI)

  9 years

Study Arms (1)

Nasopharyngeal sample

EXPERIMENTAL

Rapid completion of nasopharyngeal within 24 hours after hospitalization without exceeding 7 days after the onset

Other: nasopharyngeal sample

Interventions

nasopharyngeal sample OTHER

The nasopharyngeal sample will be used to find the types and subtypes of influenza virus and other respiratory viruses (VRS, SARS-CoV-2 and others).

Nasopharyngeal sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Rapid completion of nasopharyngeal sample after hospitalization without exceeding 7 days after the onset of Influenza-like syndrome

You may not qualify if:

• Realization of nasopharyngeal sampling more than 7 days after the onset of symptoms
• Contraindication for influenza vaccine (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
• Previously tested positive for any influenza virus in the current season (RT-PCR, multiplex RT-PCR)
• Patient under curatorship or under guardianship whose sample was obtained as part of their medical care but not complying with the conditions of Article L1121-8 of the Code de la Santé Publique.
• Patient under curatorship or under guardianship whose sample was not obtained as part of their medical care.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Institut National de la Santé Et de la Recherche Médicale

Paris, 75654, France

Location

Related Publications (7)

• Tubiana S, Launay O, Galtier F, Tattevin P, Postil D, Vanhems P, Lenzi N, Verger P, Duval X. Attitudes, knowledge, and willingness to be vaccinated against seasonal influenza among patients hospitalized with influenza-like-illness: impact of diagnostic testing. Hum Vaccin Immunother. 2020 Apr 2;16(4):851-857. doi: 10.1080/21645515.2019.1674598. Epub 2020 Mar 2.

  PMID: 31589554 RESULT

• Luque-Paz D, Tattevin P, Loubet P, Benezit F, Thibault V, Laine F, Vanhems P, Amour S, Lina B, Duval X, L'Honneur AS, Fidouh N, Vallejo C, Alain S, Galtier F, Foulongne V, Lagathu G, Lenzi N, Lesieur Z, Launay O, Jouneau S; FLUVAC Study Group. Chronic use of inhaled corticosteroids in patients admitted for respiratory virus infections: a 6-year prospective multicenter study. Sci Rep. 2022 Mar 10;12(1):4199. doi: 10.1038/s41598-022-08089-0.

  PMID: 35273311 RESULT

• Loubet P, Samih-Lenzi N, Galtier F, Vanhems P, Loulergue P, Duval X, Jouneau S, Postil D, Rogez S, Valette M, Merle C, Regis C, Costa Y, Lesieur Z, Tattevin P, Lina B, Carrat F, Launay O; FLUVAC Study Group. Factors associated with poor outcomes among adults hospitalized for influenza in France: A three-year prospective multicenter study. J Clin Virol. 2016 Jun;79:68-73. doi: 10.1016/j.jcv.2016.04.005. Epub 2016 Apr 12.

  PMID: 27105315 RESULT

• Loubet P, Mathieu P, Lenzi N, Galtier F, Laine F, Lesieur Z, Vanhems P, Duval X, Postil D, Amour S, Rogez S, Lagathu G, L'Honneur AS, Foulongne V, Houhou N, Lina B, Carrat F, Launay O; Fluvac study group. Characteristics of human metapneumovirus infection in adults hospitalized for community-acquired influenza-like illness in France, 2012-2018: a retrospective observational study. Clin Microbiol Infect. 2021 Jan;27(1):127.e1-127.e6. doi: 10.1016/j.cmi.2020.04.005. Epub 2020 Apr 10.

  PMID: 32283266 RESULT

• Loubet P, Lenzi N, Valette M, Foulongne V, Krivine A, Houhou N, Lagathu G, Rogez S, Alain S, Duval X, Galtier F, Postil D, Tattevin P, Vanhems P, Carrat F, Lina B, Launay O; FLUVAC Study Group. Clinical characteristics and outcome of respiratory syncytial virus infection among adults hospitalized with influenza-like illness in France. Clin Microbiol Infect. 2017 Apr;23(4):253-259. doi: 10.1016/j.cmi.2016.11.014. Epub 2016 Nov 27.

  PMID: 27903461 RESULT

• Descamps A, Lenzi N, Galtier F, Laine F, Lesieur Z, Vanhems P, Amour S, L'Honneur AS, Fidouh N, Foulongne V, Lagathu G, Duval X, Merle C, Lina B, Carrat F, Launay O, Loubet P; FLUVAC study group. In-hospital and midterm post-discharge complications of adults hospitalised with respiratory syncytial virus infection in France, 2017-2019: an observational study. Eur Respir J. 2022 Mar 3;59(3):2100651. doi: 10.1183/13993003.00651-2021. Print 2022 Mar.

  PMID: 34446468 RESULT

• Benezit F, Loubet P, Galtier F, Pronier C, Lenzi N, Lesieur Z, Jouneau S, Lagathu G, L'Honneur AS, Foulongne V, Vallejo C, Alain S, Duval X, Houhou N, Costa Y, Vanhems P, Amour S, Carrat F, Lina B, Launay O, Tattevin P; FLUVAC Study Group. Non-influenza respiratory viruses in adult patients admitted with influenza-like illness: a 3-year prospective multicenter study. Infection. 2020 Aug;48(4):489-495. doi: 10.1007/s15010-019-01388-1. Epub 2020 Feb 13.

  PMID: 32056143 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Odile Launay, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: January 6, 2014
• Study Start: January 1, 2014
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 24, 2026

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)