In short
Clinical trials are investigating GSKVX000000034794 in influenza vaccine studies. These trials look at immune response, safety, and reactogenicity in healthy adults and adults 18 years and older. The studies compare different vaccine versions and measure how well they work and how well they are tolerated.
Key points
- Clinical trials of GSKVX000000034794 are focused on influenza vaccine research in adults. The studies include healthy younger and older adults, and adults 18 years and older. They are in Phase 1/2 and Phase 2, which means they are testing early safety, reactogenicity, and immune response. The main outcomes include antibody levels, seroconversion, seroprotection, and safety events such as local reactions, systemic symptoms, and serious adverse events. The trial data also shows that GSKVX000000034794 is studied alongside other vaccine candidates and comparison vaccines. These studies are designed to learn how well the vaccine candidates trigger an immune response and how safe they are in the target populations.
Trial overview
GSKVX000000034794 is being studied in clinical trials for influenza, also called the flu. The trial data shows three interventional studies with different sizes, and all of them focus on vaccine research in adults or healthy volunteers.
Two studies are in Phase 2, and one study is in Phase 1/2. The studies are completed or authorised, and they use intramuscular vaccination, which means the vaccine is given into a muscle.
Who is studied in these trials
One trial includes adults 18 years of age and older, while another includes healthy younger and older adults. The third study is in healthy volunteers for prevention of influenza infection.
- Adults 18 years and older: These participants are old enough to join adult vaccine studies and are used to test immune response and safety.
- Healthy younger and older adults: This group helps researchers see how the vaccine works across different adult age ranges.
- Healthy volunteers: These are people who do not have influenza infection and join to help study prevention.
Trial phases and study design
The studies are interventional, which means participants receive a study vaccine or a comparison vaccine so researchers can compare results. A Phase 1/2 study usually looks at early safety and immune response and may help find the dose, while Phase 2 studies continue testing in larger groups.
The enrollment sizes are 770, 960, and 1272 participants, which shows that these are fairly large vaccine studies. One Phase 1/2 study is described as a dose-finding study, meaning it tries to find and confirm the best dose before moving further.
What the trials measure
The main goal across the studies is to measure the humoral immune response, which means the antibody response in the blood after vaccination. The studies also check safety and reactogenicity, which means short-term reactions after the vaccine is given.
- Antibody titer: Researchers measure antibody levels on Day 29 to see how strong the immune response is.
- Fold increase or geometric mean increase: This shows how much antibody levels rise from Day 1 to Day 29.
- Seroconversion: This measures how many participants show a clear new antibody response after vaccination.
- Seroprotection: This checks whether antibody levels reach a level considered protective in the study.
- Solicited events: These are expected reactions, such as injection-site or body-wide symptoms, tracked for 7 days after vaccination.
- Unsolicited adverse events: These are other health problems reported within 28 days after vaccination.
- Serious adverse events, adverse events of special interest, and medically attended events: These are tracked for up to 6 months to monitor more important safety outcomes.
- Laboratory abnormalities: Blood test changes are checked before dosing and after vaccination on Day 3, Day 8, and Day 29 in the studies that report this outcome.
Comparison vaccines and study groups
The studies do not test GSKVX000000034794 alone in every group. They compare it with other influenza vaccine products, including Alpharix, Alpharix-Tetra, EFLUELDA, and influenza vaccines described as inactivated split virus or recombinant haemagglutinin vaccines.
Some trial arms include GSKVX000000034794 together with other GSKVX study codes, such as GSKVX000000034798, GSKVX000000048110, GSKVX000000048111, and other related candidates. This setup helps researchers compare different vaccine versions and combinations within the same influenza program.
What the results aim to show
Across the studies, the main aim is to find out whether the vaccine candidates can trigger a useful antibody response and whether they have an acceptable safety profile. The studies also look for the best dose in the Phase 1/2 trial and check how the immune response changes over time in adults.
Because the trials focus on adults and healthy volunteers, the results are meant to help understand influenza vaccine performance in people who are being studied before broader use.