In short
Clinical trials are investigating GSKVX000000034795 as part of influenza vaccine research in healthy younger and older adults. These studies look at safety, reactogenicity, and immune response, including dose finding and confirmation. The main goal is to see how well the vaccine works in people who do not have influenza infection.
Key points
- Clinical trials of GSKVX000000034795 are studying an influenza vaccine in healthy younger and older adults. The main trial is a Phase 1/2 study, which means it looks at both safety and early immune response. Researchers are checking dose finding and dose confirmation, along with how well the vaccine is tolerated. The study also measures local and body-wide reactions, serious adverse events, and blood test changes. Immune results include antibody levels, geometric mean titer, and seroconversion rate. The trial was completed and enrolled 1,272 people.
Trial overview
The main trial for GSKVX000000034795 was a study to find and confirm the dose and assess the safety, reactogenicity, and immune response of a vaccine against influenza in healthy younger and older adults.
The study was interventional, which means participants received a study intervention rather than only being observed. It was completed and enrolled 1,272 people.
Who participated
The trial included healthy volunteers, with both younger and older adults taking part. The study focused on prevention of influenza infection rather than treatment of active flu illness.
- Healthy younger adults: adults without the illness being studied, included to help assess early vaccine response.
- Healthy older adults: older adults were also included, which helps researchers see whether the vaccine response is similar across age groups.
What was studied
The study looked at GSKVX000000034795 as part of a vaccine program against influenza. 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 caused.
Humoral immune response means the antibody response in the blood. Antibodies are proteins made by the immune system that can help protect against infection.
The intervention list shows that GSKVX000000034795 was studied in several vaccine combinations and compared with other influenza vaccine products such as Alpharix-Tetra and EFLUELDA.
Outcomes measured
The trial measured both short-term reactions and immune responses after vaccination.
- Solicited administration site events: reactions at the injection site, measured from Day 1 to Day 7.
- Solicited systemic events: body-wide reactions such as fever or tiredness, measured from Day 1 to Day 7.
- Unsolicited adverse events: any other unwanted medical events reported from Day 1 to Day 28.
- Serious adverse events: serious medical problems tracked from Day 1 to Day 183.
- Adverse events of special interest: specific safety events that the study team watched for up to Day 183.
- Medically attended events: health events that needed medical care, tracked up to Day 183.
- Laboratory value shifts: changes in blood test results from normal to abnormal, checked in Phase 1 only.
- Geometric mean titer (GMT): the average antibody level at Day 29.
- Geometric mean increase (GMI): how much antibody levels rose from Day 1 to Day 29.
- Seroconversion rate (SCR): the percentage of participants who developed a clear antibody response from Day 1 to Day 29.
- Antigen titer above a cut-off value: the percentage of participants whose antibody level reached a set threshold on Day 1 and Day 29.
The study also measured immune responses to antigen 1 and antigen 2, which suggests the vaccine response was assessed against more than one target component.
Trial phase and status
This was a Phase 1/2 trial. Phase 1/2 studies are early trials that first focus on safety and then look for early signs that the vaccine can trigger an immune response.
The trial status was Completed.
What the study means for patients
For patients, this trial shows that GSKVX000000034795 was being tested in a flu vaccine setting, not as a treatment for active influenza infection. The main questions were whether the vaccine could be given safely and whether it could produce a useful immune response in healthy adults.
Because the study included younger and older adults, it may help researchers understand how age affects vaccine response. The detailed safety and antibody measures give a fuller picture of how the vaccine behaved over time.