In short
Clinical trials investigating IMELASOMERAN are studying vaccine responses in older adults and people receiving COVID-19 vaccines. These studies look at how well different vaccine formulations work and whether they can reduce illness or improve immune response. The trials are in Phase 3 and focus on large groups of participants.
Key points
- Clinical trials investigating IMELASOMERAN are focused on vaccine research in two main areas. One Phase 3 trial studied influenza prevention in older adults and measured hospitalizations for influenza or pneumonia. Another Phase 3 trial studied COVID-19 vaccine immunology and measured antibody responses after vaccination. Both trials are completed and were done in large groups of participants. The studies focus on how well different vaccine products work in real-world or immune-response settings.
Trial overview
IMELASOMERAN is being studied in clinical trials that look at vaccine effectiveness and immune response. The available trials are both Phase 3 studies, which means they involve large groups of people and focus on how well a vaccine strategy works in practice.
Both trials are listed as completed, so the study periods have ended.
Influenza prevention study in older adults
One trial, NCT05517174, studied prevention of influenza infection in older adults. It compared a high-dose quadrivalent influenza vaccine with a standard-dose quadrivalent influenza vaccine. A quadrivalent vaccine is a vaccine designed to cover four flu strains, and “high-dose” means it contains more vaccine material than the standard dose.
This study was a pragmatic randomized trial, which means people were assigned to groups in a way that aimed to reflect real-world care. The trial enrolled 339,700 participants, making it a very large study.
The main outcome was hospitalization due to influenza or pneumonia, called a composite endpoint because it combines two related serious events into one measure. The study aimed to see whether the high-dose vaccine reduced the risk of these hospitalizations in older adults.
COVID-19 vaccine immunology study
The second trial, 2024-517357-27-00, studied COVID-19 infection and vaccine immunology. This study compared several COVID-19 vaccine products, including BIMERVAX LP.8.1, Spikevax, Comirnaty, Nuvaxovid, and a non-replicating viral vector vaccine.
The main goal was to evaluate immune responses after vaccination with different vaccine formulations. The primary outcome measured the proportion of people who were seropositive and had an antibody level above the target level 6 months after two doses against the prevailing virus variant.
This trial enrolled 4,000 participants. The study was designed to compare how different vaccine products perform in terms of antibody response over time.
Participants and trial phases
The influenza study focused on older adults, a group often included in vaccine research because they may have a higher risk of serious flu-related illness. The COVID-19 study focused on people receiving COVID-19 vaccination, with the goal of comparing immune responses across vaccine products.
Both studies were conducted in Phase 3, which is a late stage of testing before or during broader use of a vaccine. Phase 3 trials are important because they help show whether a vaccine strategy works in larger and more varied groups of people.
Main outcomes measured
The influenza trial measured hospitalization due to influenza or pneumonia. This outcome matters because it shows whether vaccination can help prevent severe illness that needs hospital care.
The COVID-19 trial measured the proportion of participants with antibody levels above a target level after vaccination. This is a way to check whether the vaccine produces a strong enough immune response in the blood.
What these trials are trying to show
These trials are not simple drug studies; they are vaccine studies that compare different vaccine approaches in specific groups. One study asks whether a higher-dose flu vaccine can better protect older adults from serious outcomes. The other asks whether different COVID-19 vaccine products lead to stronger or more durable antibody responses.
Because both studies are completed, their data can help explain how these vaccine strategies performed in large real-world or immunology-focused settings.