In short
Clinical trials are investigating GSKVX000000034796 as part of influenza vaccine research in healthy younger and older adults. These studies aim to find and confirm the dose and assess safety, reactogenicity, and immune response. The target population is healthy volunteers taking part in prevention studies for influenza infection.
Key points
- Clinical trials of GSKVX000000034796 are studying influenza prevention in healthy younger and older adults. The main trial is a Phase 1/2 study, which means it is early research that checks safety and immune response. Researchers are looking at local and whole-body reactions after vaccination, as well as blood test changes and antibody levels. The study also measures serious adverse events and other medically attended events over a longer follow-up period. The trial is completed and enrolled 1272 participants. The focus is on finding and confirming the dose while learning how the immune system responds.
Trial overview
The trial NCT05823974 is a Phase 1/2 study of an influenza vaccine program that includes GSKVX000000034796 among other study interventions. The study is designed to find and confirm the dose and to assess safety, reactogenicity, and immune response in healthy younger and older adults.
The trial is focused on prevention of influenza infection in healthy volunteers. The brief study summary states two main goals: to evaluate the safety and reactogenicity profile of the investigational study intervention and to evaluate the humoral immune response it induces.
Who can participate
This study includes healthy younger and older adults. In simple terms, that means the trial is not for people who already have influenza illness; it is for volunteers who are generally healthy and can help researchers test a vaccine approach.
The source data does not give more detailed entry rules, such as age cutoffs or medical exclusions, so only the clearly stated target population can be confirmed here.
What is being measured
The main outcomes focus on safety and immune response. Safety outcomes include the percentage of participants reporting solicited administration site events from Day 1 to Day 7, such as reactions where the shot was given.
The study also measures solicited systemic events, which are body-wide reactions such as fever or fatigue, from Day 1 to Day 7. It tracks 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.
For laboratory safety, the trial checks whether a non-clinically significant lab value on Day 1 changes to a clinically significant abnormal value on Day 8 and/or Day 29 for hematology and clinical chemistry in Phase 1 only. Hematology means blood-related tests, and clinical chemistry means tests of substances in the blood that help show how the body is working.
Immune response is measured with antibody results for antigen 1 and antigen 2. The study looks at geometric mean titer, geometric mean increase, seroconversion rate, and the percentage of participants whose antibody titer reaches a cut-off value at Day 1 and Day 29.
Study phase and design
This is an interventional study, which means participants receive a study intervention and outcomes are then measured. The phase is listed as Phase 1/2, showing that the trial combines early safety testing with early immune response assessment.
The interventions list includes multiple investigational vaccine components and comparator vaccines, including Alpharix-Tetra and EFLUELDA, along with several GSKVX-coded study products. The source data shows intramuscular administration, which means the vaccine is given into a muscle.
Study status and size
The trial status is Completed. The enrollment number is 1272 participants, which means 1272 people were included in the study.
This sample size suggests a fairly large early-stage vaccine study, allowing researchers to look at both safety patterns and immune response across different adult age groups.
Key patient points
- The trial is about influenza vaccine research and includes GSKVX000000034796 as part of the study interventions.
- It was designed for healthy younger and older adults, so the study population is people without current influenza illness.
- Researchers are mainly checking safety, short-term reactions after vaccination, and how strongly the body makes antibodies.
- The trial also measures longer-term safety events up to Day 183, including serious adverse events and medically attended events.
- The study is already completed and included 1272 participants.