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INFLUENZA VIRUS B/AUSTRIA/1359417/2021 – LIKE STRAIN (B/AUSTRIA/1359417/2021, MEDI 355292)

Clinical trials are studying INFLUENZA VIRUS B/AUSTRIA/1359417/2021 – LIKE STRAIN (B/AUSTRIA/1359417/2021, MEDI 355292) as part of influenza vaccine research. These studies look at immune response, antibody levels, and viral shedding after nasal or intramuscular vaccination in children and healthy people. Most trials are Phase 3 and aim to compare different vaccine routes and measure protection-related markers.

Table of contents

Trial overview

These trials study INFLUENZA VIRUS B/AUSTRIA/1359417/2021 – LIKE STRAIN (B/AUSTRIA/1359417/2021, MEDI 355292) in the setting of influenza vaccination research.[1][2][3] All three listed studies are Phase 3 and are marked as Authorised.[1][2][3] The studies are interventional, which means researchers give a vaccine and then measure the results.[1][2][3]

Who is being studied

One study focuses on young children and looks at immune response in the nasopharynx, which is the upper part of the throat behind the nose.[1] Another study includes healthy individuals and compares antibody responses after different vaccine routes.[3] The VAXXAIR trial studies airway immunity after nasal and intramuscular influenza vaccination.[2]

What is being measured

The first trial measures the presence or absence of viral shedding after the first and second dose of live attenuated influenza vaccine in nasal lining fluid.[1] Viral shedding means the vaccine virus can be found in a sample, and this can be used as a marker of how the body responds.[1] The VAXXAIR trial measures CD4+ T-lymphocytes and mucosal antibody rises in respiratory secretions over several time points after vaccination.[2] The third trial measures the fold change in influenza-specific IgA in nasal fluid at day 21 after intranasal vaccination compared with intramuscular vaccination.[3]

Trial designs and vaccine types

Two studies compare a nasal live attenuated influenza vaccine with an intramuscular inactivated influenza vaccine.[2][3] In the VAXXAIR trial, the nasal vaccine is compared with a placebo nasal spray and with an intramuscular vaccine arm.[2] The first trial specifically studies the immune response after a first and second dose of the nasal vaccine in children.[1]

Main endpoints

The main endpoint in the children’s study is whether vaccine-strain shedding is present or absent in nasal lining fluid after vaccination.[1] In VAXXAIR, the primary outcomes include antigen-activated CD4+ T-lymphocytes and mucosal antibody rises in respiratory secretions at several follow-up visits.[2] In the antibody study, the main endpoint is the fold change in influenza-specific IgA levels in nasal fluid at day 21.[3]

Why these trials matter

These studies try to understand how well influenza vaccines trigger mucosal immunity, which is the immune defense in the nose and airways.[1][2][3] This is important because the nose and airway lining are the first places where influenza infection can start.[1][2][3] The trials focus on immune markers rather than direct illness outcomes, helping researchers compare how different vaccination routes work in the body.[2][3]

Trial ID Phase Condition studied Status Enrollment
2024-513933-18-00 Phase 3 Influenza Authorised 20
NCT05921448 Phase 3 Influenza Authorised 55
2024-513981-21-00 Phase 3 healthy individuals Authorised 60

FAQ

  • Who is being studied in these trials? The trials include young children and healthy individuals. Some studies compare nasal and intramuscular influenza vaccination in these groups.
  • What is being measured in the trials? The studies measure immune responses such as antibody levels, CD4+ T-lymphocytes, and viral shedding. These are markers that help show how the body responds to vaccination.
  • What phase are these trials in? All listed trials are Phase 3. This means they are later-stage studies that help compare vaccine responses in people.
  • What conditions are these trials focused on? The trials are focused on influenza. One study also includes healthy individuals as the target population.
  • What types of vaccination are being compared? The trials compare intranasal live attenuated influenza vaccine with intramuscular inactivated influenza vaccine. Some studies also look at placebo controls for the nasal vaccine.

Ongoing Clinical Trials on INFLUENZA VIRUS B/AUSTRIA/1359417/2021 – LIKE STRAIN (B/AUSTRIA/1359417/2021, MEDI 355292)

  • Study on Antibody Responses in Healthy Individuals After Intranasal and Intramuscular Influenza Vaccination with Fluenz Tetra and Vaxigrip Tetra

    Recruiting

    1 1 1 1
    Investigated drugs:
    The Netherlands

  • Live Attenuated Influenza Vaccine (LAIV) and Immune Response in the Nasopharynx of Young Children with Influenza

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Influenza Immunity: Comparing Nasal FluMist and Injectable Vaxigriptetra Vaccines for Adults

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Influenza: A viral infection commonly called the flu.
  • Phase 3: A later stage of clinical research that studies how well a treatment or vaccine works in people.
  • Interventional study: A trial in which researchers give a treatment or vaccine and then measure the results.
  • Intranasal: Given through the nose.
  • Intramuscular: Given as an injection into a muscle.
  • Viral shedding: The release of virus from the body, which can be measured in samples.
  • Antibody: A protein made by the immune system to help fight infection.
  • IgA: A type of antibody often found in mucus, such as in the nose and airways.
  • IgG: A common type of antibody in the blood and body fluids.
  • CD4+ T-lymphocytes: A type of immune cell that helps coordinate the body’s defense against infection.
  • RT-qPCR: A laboratory test used to detect genetic material from a virus.

References

  1. https://clinicaltrials.gov/study/2024-513933-18-00
  2. https://clinicaltrials.eu/trial/study-on-influenza-immunity-comparing-nasal-flumist-and-injectable-vaxigriptetra-vaccines-for-adults/
  3. https://clinicaltrials.gov/study/2024-513981-21-00