- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868658
Asymptomatic Flu Project (AFP)
December 13, 2025 updated by: Hospices Civils de Lyon
Incidence of Symptomatic and Asymptomatic Influenza Among Healthcare Workers : A Multicenter Cohort Study
Although clinical presentation of influenza is often symptomatic, asymptomatic cases also occur.
The knowledge of the incidence of asymptomatic influenza among healthcare workers is very important because of the risk of cross-transmission to hospitalized patients.
The principal objective of the study is to estimate the incidence of symptomatic and asymptomatic influenza among healthcare workers in short-stay wards.
The results of this study will lead to a better understanding of the burden of asymptomatic influenza among healthcare workers and might be used as an argument to increase influenza vaccine coverage among healthcare workers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
289
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69437
- Edouard Herriot Hospital; Department of Epidemiology, Hygiene and Public Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Volunteer health-care workers
- Working in the following wards: short-stay, inpatient (including ICU) and emergency
Exclusion Criteria:
- Presence of influenza symptoms at enrolment
- Programmed absence (maternity leave, vacation, etc.)
- Administrative agents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health-care workers
Health-care workers recruited in the study will have blood sampling and naso-pharyngeal bottle-brush sampling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of influenza cases
Time Frame: 6 months after inclusion
|
Incidence of asymptomatic and symptomatic influenza per 1000 days at risk among healthcare workers
|
6 months after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fraction of asymptomatic influenza cases
Time Frame: 6 months after inclusion
|
Fraction of asymptomatic influenza cases among patients with confirmed influenza infection (seroconversion)
|
6 months after inclusion
|
|
Stratified incidence ratios
Time Frame: 6 months after inclusion
|
The objective is to compare the proportion of asymptomatic influenza among vaccinated and unvaccinated healthcare workers, stratified on the type of influenza virus , gender, age, and other covariates
|
6 months after inclusion
|
|
Incidence of influenza-like illness
Time Frame: 6 months after inclusion
|
The objective is to calculate the incidence of influenza-like illness without virological confirmation
|
6 months after inclusion
|
|
proportion of health-care workers with Influenza vaccine coverage
Time Frame: 6 months after inclusion
|
The objective is to estimate the vaccination coverage against influenza among health care workers
|
6 months after inclusion
|
|
Number of sick-leave days per participating ward
Time Frame: 6 months after inclusion
|
The objective is to estimate the professional impact of influenza in a population of healthcare workers
|
6 months after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2016
Primary Completion (Actual)
March 21, 2017
Study Completion (Actual)
March 21, 2017
Study Registration Dates
First Submitted
August 11, 2016
First Submitted That Met QC Criteria
August 11, 2016
First Posted (Estimated)
August 16, 2016
Study Record Updates
Last Update Posted (Estimated)
December 19, 2025
Last Update Submitted That Met QC Criteria
December 13, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- Orthomyxoviridae Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Influenza, Human
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- 69HCL16_0095
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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