UnknownPhase 4

Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza

Poland1,500 participantsStarted 2020-09-15

Plain-language summary

The aim of the study is to evaluate simultaneously the immunological and clinical efficacy and tolerability of an influenza vaccine, inactivated, quadrivalent, with cleaved virus, in patients at risk for severe and complicated influenza routinely vaccinated against influenza in family medicine clinics or specialty clinics (pediatric, internal medicine, cardiology, gynecological diabetes, pregnant women, transplant).

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. age over 18 (adults able to give informed consent to participate in the study) or age under 18 and the consent of a legal guardian and, in the case of persons aged 16-18, also the consent of a minor;
✓. belonging to groups at risk of severe and complicated course of influenza (children, elderly people, patients with chronic diseases, pregnant women);
✓. no clinical contraindications to influenza vaccination;
✓. the patient and/or his legal guardians give written, informed consent to participate in the study.

Exclusion criteria

✕. lack of consent to participate in the study - at every stage of the study;
✕. clinical contraindications to influenza vaccination.

What they're measuring

influenza vaccine immunogenicity, seroconversion and seroprotection

Timeframe: 4-8 weeks after vaccination

Trial details

NCT IDNCT06286488

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-23

View on ClinicalTrials.gov More Influenza trials