In short
Clinical trials are investigating GSKVX000000048111 in studies of influenza vaccines for adults and healthy volunteers. These trials look at immune response, safety, and reactogenicity, which means how often short-term side effects happen after vaccination. The studies include Phase 1/2 and Phase 2 trials in adults 18 years and older.
Key points
- GSKVX000000048111 is being studied in clinical trials for influenza vaccines. The available trials include Phase 1/2 and Phase 2 studies in adults 18 years and older, including healthy younger and older adults. The main goals are to measure immune response and safety. The studies look at antibody levels, seroconversion, seroprotection, and different types of side effects or safety events. Trial status includes completed and authorised studies. The trial data show that GSKVX000000048111 is part of larger vaccine comparisons, not a stand-alone treatment study.
Trials overview
The trial data show three interventional studies that include GSKVX000000048111 as part of influenza vaccine research. These studies were designed to assess immune response and safety in adults and healthy volunteers.
Two studies focused on adults 18 years of age and older with influenza, Human as the condition studied. One study focused on healthy younger and older adults and described prevention of influenza infection.
Who participated
The studies included adults 18 years and older, and one study also included healthy younger and older adults. This means the research was not limited to one narrow group, but the exact group depended on the specific trial.
All three studies were interventional, which means the researchers gave study vaccines and then measured the results.
What was studied
GSKVX000000048111 was studied as part of vaccine groups for influenza, not as a single stand-alone study product. The trial records list it with other GSKVX000000 products and with comparator vaccines such as Alpharix, Alpharix-Tetra, and Efluelda, as well as influenza vaccine components described as inactivated split virus or recombinant haemagglutinin.
In simple terms, the studies were comparing different influenza vaccine options to see which ones gave the best immune response and acceptable safety results.
Trial phases and study size
One study was in Phase 1/2 and two studies were in Phase 2. Phase 1/2 studies are early studies that look at safety and the first signs of immune response, while Phase 2 studies look further at safety and how the vaccine performs in a larger group.
The reported enrollment was 770 participants in one Phase 2 study, 960 in another Phase 2 study, and 1,272 in the Phase 1/2 study. Enrollment means the planned or actual number of people included in the study.
Main endpoints measured
The main endpoints were immune response measures and safety measures. Endpoints are the main results the researchers plan to measure in a trial.
- Antibody titer at Day 29 was measured to see how strong the immune response was after vaccination.
- Fold increase in antibody titer from Day 1 to Day 29 showed how much the antibody level rose after the study intervention.
- Seroconversion measured whether participants developed a new antibody response after vaccination.
- Seroprotection measured whether antibody levels reached a level thought to give protection.
The studies also measured changes in antibody levels at Day 1 and Day 29, and in one study also looked at antigen 2 results, not just antigen 1. This helps researchers compare how the body responds to different vaccine parts.
Safety and reactogenicity
The studies closely tracked solicited administration site or systemic events, which are expected short-term reactions such as pain where the shot was given or general symptoms like fever.
They also measured 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 after dosing. These safety checks help show whether any medical problems happened after vaccination and how often they occurred.
One study also measured shifts from non-clinically significant laboratory values on Day 1 to clinically significant abnormal values on Day 8 and/or Day 29 for hematology and clinical chemistry. Hematology means blood cell tests, and clinical chemistry means blood tests that check body chemicals and organ function.
Study populations and comparators
The trial records show that GSKVX000000048111 was studied alongside several other influenza vaccine candidates and licensed comparator vaccines. Comparators are other vaccines used for comparison, so researchers can judge whether the study vaccine gives similar or better immune responses and safety results.
Because the studies included both completed and authorised trials, the trial program appears to be at different stages of development. The main focus across the studies stayed the same: immune response and safety in adults and healthy volunteers.