Table of contents
- Trial overview
- Who participated
- What was studied
- Outcomes measured
- Trial phase and status
- What the study means for patients
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.[1]
The study was interventional, which means participants received a study intervention rather than only being observed.[1] It was completed and enrolled 1,272 people.[1]
Who participated
The trial included healthy volunteers, with both younger and older adults taking part.[1] The study focused on prevention of influenza infection rather than treatment of active flu illness.[1]
- Healthy younger adults: adults without the illness being studied, included to help assess early vaccine response.[1]
- Healthy older adults: older adults were also included, which helps researchers see whether the vaccine response is similar across age groups.[1]
What was studied
The study looked at GSKVX000000034795 as part of a vaccine program against influenza.[1] 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.[1]
Humoral immune response means the antibody response in the blood.[1] Antibodies are proteins made by the immune system that can help protect against infection.[1]
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.[1]
Outcomes measured
The trial measured both short-term reactions and immune responses after vaccination.[1]
- Solicited administration site events: reactions at the injection site, measured from Day 1 to Day 7.[1]
- Solicited systemic events: body-wide reactions such as fever or tiredness, measured from Day 1 to Day 7.[1]
- Unsolicited adverse events: any other unwanted medical events reported from Day 1 to Day 28.[1]
- Serious adverse events: serious medical problems tracked from Day 1 to Day 183.[1]
- Adverse events of special interest: specific safety events that the study team watched for up to Day 183.[1]
- Medically attended events: health events that needed medical care, tracked up to Day 183.[1]
- Laboratory value shifts: changes in blood test results from normal to abnormal, checked in Phase 1 only.[1]
- Geometric mean titer (GMT): the average antibody level at Day 29.[1]
- Geometric mean increase (GMI): how much antibody levels rose from Day 1 to Day 29.[1]
- Seroconversion rate (SCR): the percentage of participants who developed a clear antibody response from Day 1 to Day 29.[1]
- Antigen titer above a cut-off value: the percentage of participants whose antibody level reached a set threshold on Day 1 and Day 29.[1]
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.[1]
Trial phase and status
This was a Phase 1/2 trial.[1] 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.[1]
The trial status was Completed.[1]
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.[1] The main questions were whether the vaccine could be given safely and whether it could produce a useful immune response in healthy adults.[1]
Because the study included younger and older adults, it may help researchers understand how age affects vaccine response.[1] The detailed safety and antibody measures give a fuller picture of how the vaccine behaved over time.[1]
