In short
Clinical trials are investigating GSKVX000000070248 as part of influenza vaccine studies in adults 18 years and older. These trials look at immune response, safety, and reactogenicity, which means how often short-term reactions happen after vaccination. They compare different study vaccine groups and other influenza vaccines.
Key points
- Clinical trials of GSKVX000000070248 are studying influenza vaccine responses in adults 18 years and older. Both trials are Phase 2 interventional studies. The main goals are to measure immune response, including antibody levels, and to check safety and reactogenicity. One trial is completed and one is authorised. The studies also track short-term reactions, unsolicited adverse events, serious adverse events, and laboratory abnormalities.
Trial overview
Two Phase 2 interventional studies are investigating GSKVX000000070248 in the setting of influenza vaccination in adults. Both trials focus on influenza, human and are designed to evaluate immune response and safety.
The brief summaries for both studies say the same main goals: to evaluate the humoral immune response and the safety and reactogenicity profile of the study interventions. Humoral immune response means the antibody response in the blood.
Who was studied
The target population in both trials is adults 18 years of age and older. The trial data do not provide more detailed entry rules, so the main known group is adults in this age range.
These studies are not described as pediatric trials, and no child or adolescent group is listed in the source data.
What the trials measured
The main immune measures include antigen 1 antibody titer at Day 29, the fold increase in antibody titer from Day 1 to Day 29, seroconversion from Day 1 to Day 29, and seroprotection at Day 1 and Day 29. These outcomes help show whether the vaccine study group raised antibody levels after vaccination.
The safety measures include 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 any laboratory abnormalities before dosing and after dosing on Day 3, Day 8, and Day 29.
In simple terms, the studies watch both how the body responds and how often unwanted health events happen after vaccination.
Trial status and size
One trial, 2025-522278-35-00, is listed as Completed and enrolled 770 participants. The other trial, NCT07204964, is listed as Authorised and planned for 960 participants.
Both studies are Phase 2, which means they are beyond the earliest testing stage and are looking more closely at immune response and safety in a defined adult group.
Study comparators
The trial records show that GSKVX000000070248 was studied alongside other influenza vaccine products and study vaccine groups. The listed comparators include Alpharix trivalent influenza vaccine, inactivated split virus influenza vaccines, and recombinant hemagglutinin influenza vaccines.
These comparisons help researchers see how the study vaccine groups perform against other influenza vaccine options, but the source data do not give final head-to-head results.
Patient-friendly terms
Antibody means a protein made by the immune system to help fight infection. Seroconversion means the blood test changes in a way that shows a new or stronger antibody response after vaccination.
Seroprotection means the antibody level is thought to be high enough to help protect against flu. Reactogenicity means the expected short-term reactions after a vaccine, such as pain at the injection site or other body-wide symptoms.
Adverse event is a medical problem that happens during a study, whether or not it is caused by the study vaccine. Serious adverse event is a more severe problem that can need urgent care or hospital treatment.