Clinical trial

Immunological and Clinical Effectiveness and Tolerability of Tetravalent Inactivated Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza

Name

KB/96/2020

Description

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).

Trial arms

Trial start

2020-09-15

Estimated PCD

2023-08-23

Trial end

2026-05-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Vaxigrip

Evaluation of immunogenicity and tolerance of quadrivalent influenza vaccine in groups at risk of severe influenza, including obese adults, as well as in pregnant women (with assesment of antibodies in cord blood).

Arms:

Evaluation of immunogenicity and tolerance of quadrivalent influenza vaccine in obese adults, Immunogenicity of QIV in pregnant women, including transplacental transport of antibodies

Size

1500

Primary endpoint

influenza vaccine immunogenicity, seroconversion and seroprotection

4-8 weeks after vaccination

Eligibility criteria

Inclusion criteria for the study: 1. 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; 2. belonging to groups at risk of severe and complicated course of influenza (children, elderly people, patients with chronic diseases, pregnant women); 3. no clinical contraindications to influenza vaccination; 4. the patient and/or his legal guardians give written, informed consent to participate in the study. Exclusion criteria from the study: 1. lack of consent to participate in the study - at every stage of the study; 2. clinical contraindications to influenza vaccination. Clinical contraindications to influenza vaccination: * exacerbation of a chronic disease; * acute infectious disease; * allergy to a vaccine component; * a serious allergic reaction after a previous flu vaccination; * Guillain-Barre syndrome up to 6 weeks after the previous vaccination; * use of immunosuppressive treatment (relative contraindication)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1500, 'type': 'ACTUAL'}}

Updated at

2024-03-01

1 organization

1 product

7 indications

Organization

Medical University of Warsaw

Product

Vaxigrip

Indication

Influenza

Indication