#1 Clinical Trials Search in Europe

INFLUENZA B VIRUS YAMAGATA LINEAGE HAEMAGGLUTININ, RECOMBINANT

Clinical trials are studying INFLUENZA B VIRUS YAMAGATA LINEAGE HAEMAGGLUTININ, RECOMBINANT as part of influenza vaccine research. These studies mainly look at immunogenicity, which means how well the vaccine triggers an immune response, and safety in adults aged 50 years and older, including people with stable health conditions.

Table of contents

Trial overview

The main study was a Phase 3 interventional trial called the Celljuvant study, and it was completed.[1] It studied an adjuvanted quadrivalent subunit inactivated cell-derived influenza vaccine and included INFLUENZA B VIRUS YAMAGATA LINEAGE HAEMAGGLUTININ, RECOMBINANT among the vaccine strains being assessed.[1]

The study was designed to look first at lot-to-lot consistency, which means whether different vaccine batches gave similar immune responses.[1] It then looked at whether the vaccine response was noninferior to comparison vaccines, meaning not worse than them by more than a small allowed amount.[1]

Who participated

The trial enrolled adults aged 50 years and older.[1] Participants were healthy or had stable comorbidities, which are other health conditions that were not rapidly changing but could raise the risk of flu complications.[1]

This means the study focused on an older adult population, including people who may be at higher risk from influenza infection.[1]

What was measured

The main outcome was immunogenicity, which means how strongly the vaccine made the immune system respond.[1] The study measured this by using a hemagglutination inhibition, or HI, assay with cell-derived target viruses for the four vaccine strains.[1]

At Day 29, the trial measured the geometric mean titer and the geometric mean titer ratio for antibody levels.[1] It also measured seroconversion rate, which is the share of people whose antibody levels rose clearly from Day 1 to Day 29.[1]

Study design and phase

This was an interventional study, meaning participants received a study vaccine and the research team measured the results.[1] The trial planned to compare three consecutive vaccine lots and then compare the study vaccine with QIVr and aQIV for each vaccine strain.[1]

The enrollment was 6,300 participants, which makes this a large trial for vaccine research.[1] Large trials help researchers study immune response results in a broad group of adults.[1]

Key comparisons in the trial

The first key comparison was between three lots of the same vaccine to see if they performed similarly.[1] This is important because a vaccine should give the same result no matter which batch is used.[1]

The second key comparison was between the study vaccine and two other influenza vaccines, QIVr and aQIV.[1] The study looked at whether the immune response to INFLUENZA B VIRUS YAMAGATA LINEAGE HAEMAGGLUTININ, RECOMBINANT and the other strains was not inferior in the study vaccine group.[1]

Why these trials matter

These trials help show whether influenza vaccine batches are consistent and whether the immune response is strong enough in older adults.[1] That is especially important for adults 50 years and older, including those with stable health problems, because they may have a higher risk of flu complications.[1]

The trial data focus on immune response results rather than on treatment of disease, so the main goal is to understand how well the vaccine performs in a research setting.[1]

Trial ID Phase Condition studied Status Enrollment
2023-503763-42-00 Phase 3 Influenza vaccine immunogenicity and safety in adults 50 years and older, including healthy individuals and those with stable comorbidities Completed 6300

FAQ

  • What is being studied in trials that include INFLUENZA B VIRUS YAMAGATA LINEAGE HAEMAGGLUTININ, RECOMBINANT? The trials are studying influenza vaccine responses, especially whether the vaccine lots work consistently and whether the immune response is strong enough. They also compare the vaccine with other influenza vaccines.
  • Who can take part in these trials? The main study population is adults aged 50 years and older. People may be healthy or may have stable medical conditions that increase the risk of flu complications.
  • What phase is the main trial? The main trial is a Phase 3 study. Phase 3 trials are large studies that help confirm how well a vaccine works and continue to monitor safety.
  • What outcomes are measured in the trial? The trial measures immune response results such as geometric mean titer, seroconversion rate, and lot-to-lot consistency. These tests show how the body responds to the vaccine after vaccination.
  • Why are lot-to-lot consistency results important? Lot-to-lot consistency checks whether different production batches of the vaccine give similar immune responses. This helps show that the vaccine is made in a reliable and consistent way.

Ongoing Clinical Trials on INFLUENZA B VIRUS YAMAGATA LINEAGE HAEMAGGLUTININ, RECOMBINANT

  • Study on the Safety and Immune Response of aQIVc HD Vaccine Compared to a Drug Combination for Adults 50 Years and Older at Risk of Flu Complications

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Estonia Germany

Glossary

  • Clinical trial: A research study in people that tests a medical product, such as a vaccine, to see how well it works and how safe it is.
  • Phase 3: A late-stage trial with many participants. It helps confirm results seen in earlier studies.
  • Immunogenicity: How strongly a vaccine makes the immune system respond.
  • Safety: How well a treatment is tolerated and whether unwanted effects are watched for.
  • Stable comorbidities: Other health conditions that are present but not changing quickly or causing major new problems.
  • Hemagglutination inhibition assay: A lab test used to measure antibodies against influenza. It helps show how strong the immune response is.
  • Geometric mean titer: A way to summarize antibody levels in a group of people. It helps compare immune responses between groups.
  • Seroconversion rate: The percent of people whose blood test shows a clear rise in antibodies after vaccination.
  • Lot-to-lot consistency: A check that different batches of the same vaccine give similar results.
  • Noninferiority: A study goal showing that one treatment is not worse than another by more than a small allowed amount.

References

  1. https://clinicaltrials.gov/study/2023-503763-42-00