Table of contents
- Trial overview
- Who is being studied
- Trial phases and study design
- What the trials measure
- Trial-by-trial summary
- Patient-friendly terms used in the studies
Trial overview
GSKVX000000034798 is being studied in clinical trials as part of influenza vaccine research.[1][2][3] The trials focus on whether the study vaccines are safe and whether they trigger an immune response against influenza.[1][2][3] One study also compares GSKVX000000034798 with other influenza vaccine options.[1][2][3]
Who is being studied
The trials include healthy volunteers, including younger and older adults, as well as adults 18 years of age and older.[1][2][3] One study is specifically described as a study in healthy volunteers for prevention of influenza infection.[1] The other studies focus on adults with influenza-related vaccination needs.[2][3]
These studies are not described as treatment trials for people already sick with influenza.[1][2][3] Instead, they are vaccine studies that aim to understand prevention, immune response, and safety in people who can receive vaccination.[1][2][3]
Trial phases and study design
The trial program includes Phase 1/2 and Phase 2 studies.[1][2][3] Phase 1/2 studies are early studies that first check safety and then look at immune response in more detail.[1] Phase 2 studies are larger and continue to look at safety and immune response.[2][3]
All three trials are interventional, which means participants receive a study vaccine or a comparison vaccine rather than only being observed.[1][2][3] The studies also include comparison groups such as Alpharix, EFLUELDA, and other influenza vaccine formulations listed in the trial data.[1][2][3]
What the trials measure
The main outcomes include safety and reactogenicity, which means short-term reactions after vaccination such as local or systemic events.[1][2][3] The studies track events at the injection site and whole-body symptoms for the first 7 days after vaccination.[1][2][3] They also record unsolicited adverse events, serious adverse events, adverse events of special interest, and medically attended events over longer follow-up periods.[1][2][3]
The trials also measure the immune response by checking antibody results after vaccination.[1][2][3] Important measures include antibody titer, fold increase, seroconversion, and seroprotection at Day 29 and other time points.[1][2][3] Some outcomes also look at laboratory changes in hematology and clinical chemistry, which are blood test measures of body function.[1]
In the Phase 1/2 study, researchers also check whether non-clinically significant lab values change into clinically significant abnormal values after dosing.[1] This helps show whether the study vaccine may affect blood tests in a meaningful way.[1]
Trial-by-trial summary
NCT05823974 studied healthy younger and older adults in a Phase 1/2 design and included 1,272 participants.[1] Its brief summary says the study aimed to evaluate safety, reactogenicity, and humoral immune response, which means the antibody response in the blood.[1] The primary outcomes included local and systemic events, adverse events, serious adverse events, special-interest events, medically attended events, lab changes, and antibody measures such as GMT, GMI, and seroconversion.[1]
2025-522278-35-00 was a Phase 2 study in adults 18 years of age and older with influenza, Human, and enrolled 770 participants.[2] It aimed to evaluate humoral immune response and safety, with outcomes including antigen 1 antibody titer, fold increase, seroconversion, seroprotection, and several types of safety events.[2] The study also tracked laboratory abnormalities at Day 1, Day 3, Day 8, and Day 29.[2]
NCT07204964 is an authorised Phase 2 study in adults 18 years of age and older with influenza, Human, and it includes 960 participants.[3] Like the earlier Phase 2 study, it focuses on immune response and safety, and it measures antibody outcomes plus local, systemic, and other adverse events over time.[3] The intervention list shows several comparison vaccines and combinations that include GSKVX000000034798.[3]
Patient-friendly terms used in the studies
Antibody titer means the amount of antibodies in the blood after vaccination.[1][2][3] A higher titer often means the body has made a stronger response, but the trial is needed to measure this directly.[1][2][3]
Seroconversion means a change from not having a measurable immune response to having one after vaccination.[1][2][3] Seroprotection means an antibody level thought to give protection against infection.[2][3]
Solicited events are side effects that the study asks about on purpose, usually because they are expected after vaccination.[1][2][3] Unsolicited adverse events are other health problems that happen during the study and are reported even if they were not specifically asked about.[1][2][3]
