InfluenzaPhase 4NCT06286488
Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza
A Phase 4 study testing Vaxigrip in people with Influenza and Obesity, run by Medical University of Warsaw at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Obesity, Pregnancy; Infection
- What is being tested?
- Vaxigrip
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 sitePoland
- Study dates
- 15 Sep 2020to 1 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- lack of consent to participate in the study - at every stage of the study;
- clinical contraindications to influenza vaccination.
- Clinical contraindications to influenza vaccination:
- exacerbation of a chronic disease;
- acute infectious disease;
- allergy to a vaccine component;
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- 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)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Social Medicine and Public Health, Medical University of Warsaw
Warsaw, 02-077
About this study
Official title: Immunological and Clinical Effectiveness and Tolerability of Tetravalent Inactivated Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza
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).
Read the detailed 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).
- Conditions
- Influenza, Obesity, Pregnancy; Infection, Elderly Infection, Vaccine Reaction, Vaccine Adverse Reaction
- Being tested
- Vaxigrip
- Keywords
- influenza, vaccination, immunogenicity, efficacy, obesity, pregnancy
- Medical subject headings
- Influenza, Human, Obesity, Pregnancy Complications, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaxigripDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of immunogenicity and tolerance of quadrivalent influenza vaccine in obese adults | Experimental | Scientific observations published during the 2009 influenza pandemic have highlighted the more severe course and complications of influenza in obese people. The effect of excessive body fat in humans on the immune response to influenza vaccination is not fully explained by the available studies. Study aim was the evaluation of immunological efficacy and tolerance of QIV in obese adult patients and the relationship between the degree of obesity and immunogenicity of quadrivalent QIV in obese adult patients. Free of charge influenza vaccination was done with a quadrivalent Sanofi Pasteur Vaxigrip Tetra vaccine at a dose of 0.5 ml according to WHO recommendations for 2017/2018 for the northern hemisphere. Receives: Drug: Vaxigrip |
| Immunogenicity of QIV in pregnant women, including transplacental transport of antibodies | Experimental | Many studies confirm the safety of vaccinations against influenza during pregnancy for pregnant women as well for children. Previous studies have assessed the immunological efficacy of a monovalent and trivalent vaccine, but studies assessing the immunological efficacy and tolerability of the tetravalent, inactivated influenza vaccine in pregnant women are missing.The aim of the study is to assess immunogenicity and tolerance of tetravalent, inactivated influenza vaccine in pregnant women, depending on the duration of vaccination (II or III trimester) by assessing the level of antibodies in neonatal umbilical cord blood (transplacental transfer). Free of charge influenza vaccination was done with a quadrivalent Sanofi Pasteur Vaxigrip Tetra vaccine at a dose of 0.5 ml according to WHO recommendations for 2021/2022, 2022/2023 for the northern hemisphere. Receives: Drug: Vaxigrip |
What is being measured
The primary outcome is the main question the study is designed to answer.
influenza vaccine immunogenicity, seroconversion and seroprotection
Immunogenicity is assessed using a hemagglutinin inhibition test. Percentage of patients with influenza antibody titers of 1:40 or more after vaccination. Seroconversion rate-a fourfold increase in the geometric mean titer after vaccination and the percentage of newborns with antibody titers of 1:40 or more at birth. Seroconversion and seroprotection were compared against the second and third trimesters of pregnancy. Transplacental transfer of antibodies was compared according to whether or not the patient had been vaccinated in previous seasons (applies only to the study on pregnant women.
Measured: 4-8 weeks after vaccination
Secondary outcomes (1)
assessment of vaccination tolerance
Each patient will keep a diary of symptoms of adverse events occurring after vaccination and after 4 weeks will be asked to complete a survey (the survey was created in accordance with the Summary of Product Characteristics, CPMP and International Committee for Harmonization guidelines for the management of clinical safety data: definitions and standards for accelerated reporting).
Measured: 30 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start15 Sep 2020
- Primary completion23 Aug 2023
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANNA JAGIELSKA, Medical University of Warsaw
- Investigators
- Monika Zasztowt-Sternicka, MD, Principal investigator, Doctoral School, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286488
- Sponsor's protocol ID
- KB/96/2020
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zasztowt-Sternicka M, Jagielska A, Rzad M, Szymusik I, Hallmann E, Brydak L, Nitsch-Osuch A. Immunogenicity of inactivated quadrivalent influenza vaccine in pregnant women, including the level of postvaccination antibodies in umbilical cord blood. Vaccine. 2025 Apr 19;53:127047. doi: 10.1016/j.vaccine.2025.127047. Epub 2025 Apr 8.
PubMed 40203592
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological and Clinical Effectiveness and Tolerability of Tetravalent Inactivated Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza
- ClinicalTrials.gov ID
- NCT06286488
- Acronym / sponsor ID
- KB/96/2020
- Conditions
- Influenza, Obesity, Pregnancy; Infection, Elderly Infection, Vaccine Reaction, Vaccine Adverse Reaction
- Keywords
- influenza, vaccination, immunogenicity, efficacy, obesity, pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evaluation of immunogenicity and tolerance of quadrivalent influenza vaccine in obese adults | Experimental | Drug: VaxigripScientific observations published during the 2009 influenza pandemic have highlighted the more severe course and complications of influenza in obese people. The effect of excessive body fat in humans on the immune response to influenza vaccination is not fully explained by the available studies. Study aim was the evaluation of immunological efficacy and tolerance of QIV in obese adult patients and the relationship between the degree of obesity and immunogenicity of quadrivalent QIV in obese adult patients. Free of charge influenza vaccination was done with a quadrivalent Sanofi Pasteur Vaxigrip Tetra vaccine at a dose of 0.5 ml according to WHO recommendations for 2017/2018 for the northern hemisphere. |
| Immunogenicity of QIV in pregnant women, including transplacental transport of antibodies | Experimental | Drug: VaxigripMany studies confirm the safety of vaccinations against influenza during pregnancy for pregnant women as well for children. Previous studies have assessed the immunological efficacy of a monovalent and trivalent vaccine, but studies assessing the immunological efficacy and tolerability of the tetravalent, inactivated influenza vaccine in pregnant women are missing.The aim of the study is to assess immunogenicity and tolerance of tetravalent, inactivated influenza vaccine in pregnant women, depending on the duration of vaccination (II or III trimester) by assessing the level of antibodies in neonatal umbilical cord blood (transplacental transfer). Free of charge influenza vaccination was done with a quadrivalent Sanofi Pasteur Vaxigrip Tetra vaccine at a dose of 0.5 ml according to WHO recommendations for 2021/2022, 2022/2023 for the northern hemisphere. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- lack of consent to participate in the study - at every stage of the study;
- clinical contraindications to influenza vaccination.
- exacerbation of a chronic disease;
- acute infectious disease;
- allergy to a vaccine component;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaxigripEvaluation 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). | Drug | Evaluation of immunogenicity and tolerance of quadrivalent influenza vaccine in obese adults, Immunogenicity of QIV in pregnant women, including transplacental transport of antibodies |
Primary outcome
influenza vaccine immunogenicity, seroconversion and seroprotection
Time frame: 4-8 weeks after vaccination
Immunogenicity is assessed using a hemagglutinin inhibition test. Percentage of patients with influenza antibody titers of 1:40 or more after vaccination. Seroconversion rate-a fourfold increase in the geometric mean titer after vaccination and the percentage of newborns with antibody titers of 1:40 or more at birth. Seroconversion and seroprotection were compared against the second and third trimesters of pregnancy. Transplacental transfer of antibodies was compared according to whether or not the patient had been vaccinated in previous seasons (applies only to the study on pregnant women.
1 secondary outcome
assessment of vaccination tolerance
Time frame: 30 days after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Derived from this study: PubMed 40203592Zasztowt-Sternicka M, Jagielska A, Rzad M, Szymusik I, Hallmann E, Brydak L, Nitsch-Osuch A. Immunogenicity of inactivated quadrivalent influenza vaccine in pregnant women, including the level of postvaccination antibodies in umbilical cord blood. Vaccine. 2025 Apr 19;53:127047. doi: 10.1016/j.vaccine.2025.127047. Epub 2025 Apr 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Zasztowt-Sternicka, MD principal investigator
Doctoral School, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaxigrip in people with Influenza and Obesity, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
influenza vaccine immunogenicity, seroconversion and seroprotection (time frame: 4-8 weeks after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06286488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.