In short
Clinical trials are investigating GSKVX000000040033 as part of an influenza vaccine study in healthy younger and older adults. The trials aim to find and confirm the dose, and to assess safety, reactogenicity, and immune response. They include healthy volunteers and are designed to compare different vaccine options.
Key points
- Clinical trials of GSKVX000000040033 are studying an influenza vaccine in healthy younger and older adults. The main trial is Phase 1/2 and has been completed. Researchers are looking at dose finding, safety, reactogenicity, and immune response. The study includes healthy volunteers and compares the investigational vaccine with other influenza vaccine options. Main outcomes include local and whole-body reactions, adverse events, and antibody measures such as GMT and seroconversion rate.
Trial overview
The main study in the source data is NCT05823974, a completed interventional trial of GSKVX000000040033 in healthy younger and older adults. The study title says it was designed to find and confirm the dose and to assess safety, reactogenicity, and immune response for an influenza vaccine.
Who participated
The trial enrolled healthy volunteers, including younger and older adults. The condition listed in the source is prevention of influenza infection, so the study was not for people already sick with influenza.
What was studied
The source data shows that GSKVX000000040033 was studied as part of a vaccine program for influenza prevention. The brief summary says the trial aimed to evaluate the safety and reactogenicity profile of the investigational study intervention and the humoral immune response it induced. Humoral immune response means the antibody response in the blood.
Trial phase and status
The study was a Phase 1/2 trial, which usually means early testing in people to learn about safety and early signs of immune response. The trial status is listed as Completed. The enrollment was 1272 participants.
Endpoints and what they mean
The trial measured several safety outcomes, including solicited administration site events and solicited systemic events from Day 1 to Day 7. Solicited events are side effects that researchers ask about on purpose after vaccination, such as pain where the shot was given or body-wide symptoms like fever or tiredness.
The study also measured unsolicited adverse events from Day 1 to Day 28, plus serious adverse events, adverse events of special interest, and medically attended events through Day 183. These terms mean, respectively, any extra unwanted health problem reported by the participant, severe medical problems, side effects that need special monitoring, and health problems that lead to medical care.
For laboratory safety, the Phase 1 part of the study checked whether a non-clinically significant lab value on Day 1 changed to a clinically significant abnormal value on Day 8 and/or Day 29 for hematology and clinical chemistry. Hematology means blood tests, and clinical chemistry means tests that measure substances in the blood such as salts, sugar, and organ-related markers.
The immune response outcomes included geometric mean titer (GMT), geometric mean increase (GMI), seroconversion rate (SCR), and the percentage of participants with antibody levels above a cut-off value at Day 1 and Day 29. These results were reported for antigen 1 and antigen 2, showing that the study looked at how strongly the immune system responded to more than one vaccine target.
Comparators and study design
The intervention list shows that the study included GSKVX000000040033 in different vaccine combinations and also compared it with licensed influenza vaccines such as Alpharix-Tetra and EFLUELDA. This kind of comparison helps researchers see how the investigational vaccine performs against existing vaccines in healthy adults.
The source data does not provide more details about randomization, masking, or exact dose groups, so those points are not described here.