Table of Contents
- Trial overview
- Who is being studied
- What the trials measure
- Trial status and size
- Study design and vaccine comparisons
- What these results mean for patients
Trial overview
Two Phase 2 clinical trials are studying GSKVX000000070250 in the setting of influenza vaccination research.[1][2] Both studies are interventional, which means researchers give study vaccines and then measure the results.[1][2]
Both trials focus on influenza, Human, and both aim to evaluate immune response and safety.[1][2] The source data describes GSKVX000000070250 as one of several study interventions used in these flu vaccine trials.[1][2]
Who is being studied
The trials are in adults 18 years of age and older.[1][2] The source data does not give more detailed inclusion or exclusion rules, so the available information only confirms the adult age group.[1][2]
These studies are meant for people who can take part in influenza vaccine research, not for children or adolescents, based on the trial titles and descriptions provided.[1][2]
What the trials measure
The main immune outcome is the antibody titer for antigen 1 at Day 29, along with the fold increase from Day 1 to Day 29.[1][2] Antibody titer is a blood test measure that shows how much antibody the body has made after vaccination.[1][2]
The trials also measure seroconversion and seroprotection at Day 1 and Day 29.[1][2] Seroconversion means a person develops a measurable antibody response, while seroprotection means the antibody level is thought to provide protection.[1][2]
Safety is also a major goal, with tracking of solicited administration site or systemic events within 7 days, unsolicited adverse events within 28 days, serious adverse events within 6 months, adverse events of special interest within 6 months, medically attended adverse events within 6 months, and laboratory abnormalities at several time points after dosing.[1][2]
In simple terms, the studies are checking both how well the vaccine response works and how the body tolerates the study vaccines over time.[1][2]
Trial status and size
One trial, 2025-522278-35-00, is listed as Completed and includes 770 participants.[1] The other trial, NCT07204964, is listed as Authorised and includes 960 participants.[2]
Together, these studies show that GSKVX000000070250 is being tested in a moderate-size Phase 2 program focused on flu vaccination outcomes.[1][2]
Study design and vaccine comparisons
The trial data shows that GSKVX000000070250 is compared with other influenza vaccine options, including an inactivated split virus vaccine and a recombinant influenza vaccine.[1][2] These names refer to different ways flu vaccines are made, but the source data does not go into more detail about how they work.[1][2]
Both trials use a 0.5 ml intramuscular dose, meaning the study vaccine is given into a muscle in a 0.5 millilitre amount.[1][2] The source data does not provide the full schedule of all doses, so only the listed administration details are included here.[1][2]
What these results mean for patients
For patients, these trials are mainly about whether the flu vaccine study groups can create a strong antibody response and whether the vaccines are well tolerated.[1][2] The most important results are the immune markers at Day 29 and the safety findings collected soon after vaccination and over the following months.[1][2]
Because the available data comes from Phase 2 influenza vaccine studies, the focus is on learning more about performance and safety in adults before any later-stage research decisions.[1][2]
