Clinical Trial to Assess the Influenza Vaccination of the Hospitalized Adults (NCT02027233) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Assess the Influenza Vaccination of the Hospitalized Adults
France6,173 participantsStarted 2014-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 before the hospitalization (even if symptoms are not present at the time of inclusion), or less than 48 hours after the hospitalization
* Rapid completion of nasopharyngeal sample after hospitalization without exceeding 7 days after the onset of Influenza-like syndrome
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measure of vaccine efficacy in population by comparing the number of influenza cases virologically documented in hospitalized patients vaccinated and unvaccinated.
Timeframe: 9 years
Trial details
NCT IDNCT02027233
SponsorInstitut National de la Santé Et de la Recherche Médicale, France