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

NCT06286488 | Active Not Recruiting Phase 4

• 1 other identifier: KB/96/2020
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

influenza; vaccination; immunogenicity; efficacy; obesity; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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.

  4-8 weeks after vaccination

Secondary Outcomes (1)

• assessment of vaccination tolerance

  30 days after vaccination

Study Arms (2)

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.

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.

Drug: Vaxigrip

Interventions

Vaxigrip DRUG

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).

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: In the arm concerning pregnant patients, only women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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)

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Social Medicine and Public Health, Medical University of Warsaw

Warsaw, 02-077, Poland

Location

Related Publications (1)

• 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.

  PMID: 40203592 DERIVED

MeSH Terms

Conditions

Influenza, Human; Obesity; Pregnancy Complications, Infectious

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Monika Zasztowt-Sternicka, MD

  Doctoral School, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: September 15, 2020
• Primary Completion: August 23, 2023
• Study Completion: May 1, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)