In short
Clinical trials are investigating GSKVX000000034798 as part of influenza vaccine studies in healthy adults and adults 18 years and older. These trials look at safety, reactogenicity, and immune response, with some also comparing GSKVX000000034798 to other influenza vaccines. The studies include Phase 1/2 and Phase 2 research.
Key points
- Clinical trials of GSKVX000000034798 are studying influenza vaccine use in healthy adults and adults 18 years and older. The research includes Phase 1/2 and Phase 2 studies. The main goals are to assess safety, reactogenicity, and immune response. Researchers measure antibody levels, seroconversion, seroprotection, and different types of adverse events. One trial focuses on healthy volunteers, while the others study adults with influenza-related vaccination needs.
Trial overview
GSKVX000000034798 is being studied in clinical trials as part of influenza vaccine research. The trials focus on whether the study vaccines are safe and whether they trigger an immune response against influenza. One study also compares GSKVX000000034798 with other influenza vaccine options.
Who is being studied
The trials include healthy volunteers, including younger and older adults, as well as adults 18 years of age and older. One study is specifically described as a study in healthy volunteers for prevention of influenza infection. The other studies focus on adults with influenza-related vaccination needs.
These studies are not described as treatment trials for people already sick with influenza. Instead, they are vaccine studies that aim to understand prevention, immune response, and safety in people who can receive vaccination.
Trial phases and study design
The trial program includes Phase 1/2 and Phase 2 studies. Phase 1/2 studies are early studies that first check safety and then look at immune response in more detail. Phase 2 studies are larger and continue to look at safety and immune response.
All three trials are interventional, which means participants receive a study vaccine or a comparison vaccine rather than only being observed. The studies also include comparison groups such as Alpharix, EFLUELDA, and other influenza vaccine formulations listed in the trial data.
What the trials measure
The main outcomes include safety and reactogenicity, which means short-term reactions after vaccination such as local or systemic events. The studies track events at the injection site and whole-body symptoms for the first 7 days after vaccination. They also record unsolicited adverse events, serious adverse events, adverse events of special interest, and medically attended events over longer follow-up periods.
The trials also measure the immune response by checking antibody results after vaccination. Important measures include antibody titer, fold increase, seroconversion, and seroprotection at Day 29 and other time points. Some outcomes also look at laboratory changes in hematology and clinical chemistry, which are blood test measures of body function.
In the Phase 1/2 study, researchers also check whether non-clinically significant lab values change into clinically significant abnormal values after dosing. This helps show whether the study vaccine may affect blood tests in a meaningful way.
Trial-by-trial summary
NCT05823974 studied healthy younger and older adults in a Phase 1/2 design and included 1,272 participants. Its brief summary says the study aimed to evaluate safety, reactogenicity, and humoral immune response, which means the antibody response in the blood. The primary outcomes included local and systemic events, adverse events, serious adverse events, special-interest events, medically attended events, lab changes, and antibody measures such as GMT, GMI, and seroconversion.
2025-522278-35-00 was a Phase 2 study in adults 18 years of age and older with influenza, Human, and enrolled 770 participants. It aimed to evaluate humoral immune response and safety, with outcomes including antigen 1 antibody titer, fold increase, seroconversion, seroprotection, and several types of safety events. The study also tracked laboratory abnormalities at Day 1, Day 3, Day 8, and Day 29.
NCT07204964 is an authorised Phase 2 study in adults 18 years of age and older with influenza, Human, and it includes 960 participants. Like the earlier Phase 2 study, it focuses on immune response and safety, and it measures antibody outcomes plus local, systemic, and other adverse events over time. The intervention list shows several comparison vaccines and combinations that include GSKVX000000034798.
Patient-friendly terms used in the studies
Antibody titer means the amount of antibodies in the blood after vaccination. A higher titer often means the body has made a stronger response, but the trial is needed to measure this directly.
Seroconversion means a change from not having a measurable immune response to having one after vaccination. Seroprotection means an antibody level thought to give protection against infection.
Solicited events are side effects that the study asks about on purpose, usually because they are expected after vaccination. Unsolicited adverse events are other health problems that happen during the study and are reported even if they were not specifically asked about.