MedTrace Logo

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

NCT06286488 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2024-03-01

No results posted yet for this study

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).

Conditions

  • Influenza
  • Obesity
  • Pregnancy; Infection
  • Elderly Infection
  • Vaccine Reaction
  • Vaccine Adverse Reaction
  • Tolerance

Interventions

DRUG

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).

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Monika Zasztowt-Sternicka, MD · Doctoral School, Medical University of Warsaw

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2023-08-23
Completion
2026-05-01

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06286488 on ClinicalTrials.gov