In short
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.
Key points
- Clinical trials involving INFLUENZA B VIRUS YAMAGATA LINEAGE HAEMAGGLUTININ, RECOMBINANT are studying influenza vaccine responses in adults aged 50 years and older. The main trial is a Phase 3 study with 6,300 participants and is marked completed. It includes healthy adults and people with stable health conditions that raise the risk of flu complications. The study looks at immune response measures such as geometric mean titer, seroconversion rate, and lot-to-lot consistency. It compares different vaccine lots and also compares the vaccine with other influenza vaccines. The focus is on whether the vaccine gives a similar and strong immune response across groups and batches.
Trial overview
The main study was a Phase 3 interventional trial called the Celljuvant study, and it was completed. 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.
The study was designed to look first at lot-to-lot consistency, which means whether different vaccine batches gave similar immune responses. 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.
Who participated
The trial enrolled adults aged 50 years and older. 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.
This means the study focused on an older adult population, including people who may be at higher risk from influenza infection.
What was measured
The main outcome was immunogenicity, which means how strongly the vaccine made the immune system respond. The study measured this by using a hemagglutination inhibition, or HI, assay with cell-derived target viruses for the four vaccine strains.
At Day 29, the trial measured the geometric mean titer and the geometric mean titer ratio for antibody levels. It also measured seroconversion rate, which is the share of people whose antibody levels rose clearly from Day 1 to Day 29.
Study design and phase
This was an interventional study, meaning participants received a study vaccine and the research team measured the results. The trial planned to compare three consecutive vaccine lots and then compare the study vaccine with QIVr and aQIV for each vaccine strain.
The enrollment was 6,300 participants, which makes this a large trial for vaccine research. Large trials help researchers study immune response results in a broad group of adults.
Key comparisons in the trial
The first key comparison was between three lots of the same vaccine to see if they performed similarly. This is important because a vaccine should give the same result no matter which batch is used.
The second key comparison was between the study vaccine and two other influenza vaccines, QIVr and aQIV. 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.
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. 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.
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.