NCT01764152

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 2, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

December 21, 2012

Last Update Submit

August 25, 2025

Conditions

Adult Hospitalized

Keywords

Prevention,influenza,adults hospitalized,vaccines,Effectiveness

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.

    6 months

Secondary Outcomes (3)

  • 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

Study Arms (1)

Nasopharyngeal sample

EXPERIMENTAL

one will be taken nasopharyngeal all patients hospitalized for 24 hours with ILI in the last seven days.

Other: nasopharyngeal sample

Interventions

nasopharyngeal sampleOTHER

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

Nasopharyngeal sample

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut National de la Santé Et de la Recherche Médicale

Paris, 75654, France

Location

Related Publications (2)

  • Puig-Barbera J, Tormos A, Sominina A, Burtseva E, Launay O, Ciblak MA, Natividad-Sancho A, Buigues-Vila A, Martinez-Ubeda S, Mahe C; GIHSN Group. First-year results of the Global Influenza Hospital Surveillance Network: 2012-2013 Northern hemisphere influenza season. BMC Public Health. 2014 Jun 5;14:564. doi: 10.1186/1471-2458-14-564.

    PMID: 24903737BACKGROUND

  • Puig-Barbera J, Natividad-Sancho A, Launay O, Burtseva E, Ciblak MA, Tormos A, Buigues-Vila A, Martinez-Ubeda S, Sominina A; GIHSN Group. 2012-2013 Seasonal influenza vaccine effectiveness against influenza hospitalizations: results from the global influenza hospital surveillance network. PLoS One. 2014 Jun 19;9(6):e100497. doi: 10.1371/journal.pone.0100497. eCollection 2014.

    PMID: 24945510BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory 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 21, 2012

First Posted

January 9, 2013

Study Start

December 1, 2012

Primary Completion

April 1, 2013

Study Completion

May 1, 2013

Last Updated

September 2, 2025

Record last verified: 2025-03

Locations

FR(1)