Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT06286488 |
Other study ID # |
KB/96/2020 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
September 15, 2020 |
Est. completion date |
May 1, 2026 |
Study information
Verified date |
February 2024 |
Source |
Medical University of Warsaw |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
Description:
Influenza has been called the last uncontrollable scourge of mankind because of its epidemic
and pandemic potential. According to WHO estimates, 5-10% of the adult population and 10-20%
of children globally fall ill with influenza seasonally. Influenza incidence has implications
for individual patients (risk of complications, hospitalization, disability and death), as
well as for public health (increased outpatient consultations, hospitalizations, including in
intensive care units, increased absenteeism from work). Groups at risk for post-influenza
complications include children under the age of 5, seniors over 65, patients with chronic
diseases such as respiratory, cardiovascular, metabolic conditions, obesity,
immunosuppressive treatment, and pregnant women, among others. Since the influenza A
H1N1pdm09 pandemic, the WHO has particularly emphasized the need to vaccinate patients at
risk of severe and complicated influenza, and has recommended a tetravalent vaccine since
2013. The inactivated tetravalent influenza vaccine has been available in Poland since the
2016/17 season, and also registered for children since the 2018/19 season. This is also in
line with current Polish recommendations issued by the National Influenza Control Program.
With the extremely low level of vaccination against influenza of the Polish population (about
3.7%), the threat of an influenza epidemic is serious. The number of reports describing
simultaneously the immunological and clinical efficacy and tolerance of influenza vaccination
of the Polish population is limited, the published works usually focus on the evaluation of
either immunogenicity or clinical efficacy, there is a lack of publications comprehensively
determining the effectiveness of the vaccine in the Polish homogeneous population, especially
people in the above-mentioned risk groups, as well as the determination of the occurrence of
the phenomenon of non-immunogenicity of the vaccine in the Polish population. An important
aspect in the situation of low immunogenicity of the Polish population is the aspect of
persistence of protective antibody levels at the beginning of the next flu season. Few works
indicate the persistence of protective antibody levels in healthy individuals without risk
factors for immune disorders, but the quality of "immune memory" after influenza vaccination
in patients at risk of severe and complicated influenza is still insufficiently understood.
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).