#1 Clinical Trials Search in Europe

INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2)

Clinical trials investigating INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) are studying influenza vaccine research in different groups of people. These studies look at safety, immune response, and how well vaccines help prevent influenza-related illness. The target groups include healthy adults, older adults, and patients with hematological cancer.

Table of Contents

Overview of the trials

The clinical trials for INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) are vaccine studies focused on preventing influenza and related illness.[1] The trial data show research on vaccine effectiveness, immune response, safety, and reactogenicity, which means short-term reactions after vaccination.[1] Some studies compare high-dose and standard-dose influenza vaccines, while others test vaccine use in older adults or in patients with hematological cancer.[1][2][3]

Who the trials include

These trials include several patient groups, so the study results can apply to different levels of risk and immune health.[1] One large Phase 3 study includes adults aged 65 to 79 years in Galicia, Spain, and looks at prevention of influenza infection.[1] Another Phase 3 study includes adults treated for hematological cancer, which means cancers of the blood or bone marrow, and compares two influenza vaccine doses.[2] A Phase 1/2 study includes healthy younger and older adults, and one Phase 3 study includes adults aged 65 years or older.[4][3]

Trial designs and phases

The trial set includes both Phase 1/2 and Phase 3 studies.[4][1][2][3]

Phase 1/2 research usually looks first at safety and early immune response in a smaller or mixed group of participants.[4] Phase 3 studies are larger and are used to compare how well different vaccine strategies work and how safe they are in real-world-like groups.[1][2][3]

One study is a randomized trial, which means participants are assigned by chance to different vaccine groups.[1][2][4] One study is also described as double-blind, meaning the people in the study do not know which treatment they receive, helping reduce bias in the results.[3]

What the trials measure

The main outcomes are linked to both clinical events and immune response.[1][2][3][4]

  • Hospitalization due to influenza or pneumonia: one Phase 3 study uses this combined outcome to see whether high-dose vaccine lowers the risk of serious illness.[1]

  • Seroconversion: one cancer study measures whether participants develop a clear blood antibody response after vaccination.[2]

  • Hemagglutination inhibition (HI) titers: one study measures antibody levels against each influenza strain 29 days after vaccination, which helps show immune response.[3]

  • Safety and reactogenicity: one Phase 1/2 study tracks local and general symptoms, unwanted events, serious adverse events, and medically attended events over time.[4]

  • Laboratory changes: the Phase 1 part of the study also checks whether blood test values change from normal to abnormal after vaccination.[4]

Key trials in this set

The largest Phase 3 study in adults aged 65 to 79 years compares high-dose quadrivalent influenza vaccine with standard-dose quadrivalent influenza vaccine and looks at hospitalization for influenza or pneumonia as the main endpoint.[1] Its enrollment is 114,011, which makes it the largest study in the provided data.[1]

The Flu-Hemato-Rando study is a Phase 3 randomized single-blind trial in adults treated for hematological cancer.[2] It compares high-dose and standard-dose inactivated influenza vaccine and also includes a systems biology part, which means detailed study of how the body responds at a biological level.[2]

Another Phase 3 study in adults aged 65 years or older tests whether giving ExPEC9V together with a high-dose quadrivalent influenza vaccine affects immune response, safety, and reactogenicity.[3] This study is useful because it looks at vaccine co-administration, meaning two vaccines are given together.[3]

The Phase 1/2 study in healthy younger and older adults aims to find and confirm the dose and to assess safety, reactogenicity, and immune response.[4] It also measures several antibody results over time, including geometric mean titer and seroconversion rate.[4]

Simple explanation of important terms

Enrollment means the number of people planned or included in a study.[1][2][3][4]

Interventional study means the researchers give a vaccine or another study treatment and then measure the results.[1][2][3][4]

Primary endpoint means the main result the researchers want to measure.[1][2][3][4]

Humoral immune response means the body’s antibody response in the blood after vaccination.[2][3][4]

Adverse event means any unwanted medical problem seen during a study, whether or not it is caused by the vaccine.[4]

Trial ID Phase Condition studied Status Enrollment
2023-506977-36-00 Phase 3 Prevention of influenza infection in adults aged 65-79 years Authorised 114011
2023-505357-40-00 Phase 3 Hematological cancer Authorised 180
2023-504168-40-00 Phase 3 Prevention of invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease Completed 932
NCT05823974 Phase 1/2 Healthy volunteers (prevention of influenza infection) Completed 1272

FAQ

  • Who can take part in trials investigating INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2)? The trials include different groups, such as healthy younger and older adults, adults aged 65 years or older, adults aged 65 to 79 years, and patients treated for hematological cancer. Each study has its own entry rules.
  • What are these trials trying to find out? They are mainly studying whether influenza vaccines are safe, how the body responds to them, and how well they help prevent influenza or influenza-related illness. Some trials also compare high-dose and standard-dose vaccines.
  • What trial phases are listed? The studies are in Phase 1/2 and Phase 3. Phase 1/2 studies usually focus more on safety and early immune response, while Phase 3 studies test effectiveness and safety in larger groups.
  • What conditions are being studied in these trials? The main condition is prevention of influenza infection. One study also looks at prevention of hospitalization due to influenza or pneumonia, and another includes patients with hematological cancer.
  • What kinds of results are being measured? The trials measure outcomes such as hospitalizations, antibody response, seroconversion, safety events, and other signs of immune response. Some studies also track adverse events and lab changes over time.

Ongoing Clinical Trials on INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2)

  • Study Comparing High-Dose and Standard-Dose Inactivated Influenza Vaccines in Adults with Blood Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on the Effectiveness of High-Dose vs. Standard-Dose Quadrivalent Influenza Vaccine in Preventing Flu in Adults Aged 65-79 in Galicia, Spain

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Safety and Immune Response of JNJ-78901563 and High-dose Influenza Vaccine in Preventing E. coli Infections in Adults Aged 65 and Older

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Poland

  • Study on the Safety and Immune Response of a New Influenza Vaccine with GSKVX000000034794 in Healthy Younger and Older Adults

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • Influenza: A viral infection often called the flu. These trials study ways to prevent it.
  • Vaccine effectiveness: How well a vaccine works in real life to prevent disease or serious illness.
  • Immunogenicity: How strongly a vaccine makes the immune system respond.
  • Reactogenicity: Short-term reactions after vaccination, such as local or general symptoms that are tracked in the study.
  • Seroconversion: A change in blood test results that shows the body has started making a measurable immune response.
  • Antibody titer: A lab measure of how much antibody is in the blood.
  • Geometric mean titer (GMT): An average way to describe antibody levels in a group of people.
  • Randomized trial: A study where participants are put into different groups by chance.
  • Double-blind: A study design where participants and often study staff do not know which treatment was given.
  • Composite endpoint: A study result that combines more than one event, such as hospitalization for influenza or pneumonia.

References

  1. https://clinicaltrials.gov/study/2023-506977-36-00
  2. https://clinicaltrials.gov/study/2023-505357-40-00
  3. https://clinicaltrials.gov/study/2023-504168-40-00
  4. https://clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-a-new-influenza-vaccine-with-gskvx000000034794-in-healthy-younger-and-older-adults/