Table of contents

• Trial overview
• Who can participate
• What is being measured
• Study phase and design
• Study status and size
• Key patient points

Trial overview

The trial NCT05823974 is a Phase 1/2 study of an influenza vaccine program that includes GSKVX000000034796 among other study interventions.^[1] The study is designed to find and confirm the dose and to assess safety, reactogenicity, and immune response in healthy younger and older adults.^[1]

The trial is focused on prevention of influenza infection in healthy volunteers.^[1] 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.^[1]

Who can participate

This study includes healthy younger and older adults.^[1] 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.^[1]

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.^[1]

What is being measured

The main outcomes focus on safety and immune response.^[1] 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.^[1]

The study also measures solicited systemic events, which are body-wide reactions such as fever or fatigue, from Day 1 to Day 7.^[1] 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.^[1]

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.^[1] Hematology means blood-related tests, and clinical chemistry means tests of substances in the blood that help show how the body is working.^[1]

Immune response is measured with antibody results for antigen 1 and antigen 2.^[1] 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.^[1]

Study phase and design

This is an interventional study, which means participants receive a study intervention and outcomes are then measured.^[1] The phase is listed as Phase 1/2, showing that the trial combines early safety testing with early immune response assessment.^[1]

The interventions list includes multiple investigational vaccine components and comparator vaccines, including Alpharix-Tetra and EFLUELDA, along with several GSKVX-coded study products.^[1] The source data shows intramuscular administration, which means the vaccine is given into a muscle.^[1]

Study status and size

The trial status is Completed.^[1] The enrollment number is 1272 participants, which means 1272 people were included in the study.^[1]

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.^[1]

Key patient points

• The trial is about influenza vaccine research and includes GSKVX000000034796 as part of the study interventions.^[1]

• It was designed for healthy younger and older adults, so the study population is people without current influenza illness.^[1]

• Researchers are mainly checking safety, short-term reactions after vaccination, and how strongly the body makes antibodies.^[1]

• The trial also measures longer-term safety events up to Day 183, including serious adverse events and medically attended events.^[1]

• The study is already completed and included 1272 participants.^[1]