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GSKVX000000034797

Clinical trials are investigating GSKVX000000034797 as part of an influenza vaccine study in healthy younger and older adults. The trial is looking at safety, reactogenicity, and immune response, and it compares study vaccine groups with licensed flu vaccines.

Table of contents

Trial overview

The clinical trial for GSKVX000000034797 studied an influenza vaccine program in healthy younger and older adults.[1] The study was designed to find and confirm the dose, and to assess safety, reactogenicity, and immune response.[1]

This was an interventional study, which means participants received a study intervention rather than only being observed.[1] The trial is listed as completed and enrolled 1272 participants.[1]

Who participated

The target population was healthy younger and older adults.[1] This means the study focused on adults without the illness being prevented, so researchers could see how the vaccine was tolerated and how the immune system responded.[1]

The study was about prevention of influenza infection, so it was not aimed at people already being treated for flu illness.[1]

What was studied

GSKVX000000034797 was studied as one of several vaccine groups in a flu vaccine trial.[1] Some groups included GSKVX000000034797 together with other study codes, and some groups compared study vaccines with licensed influenza vaccines such as Alpharix-Tetra and Efluelda.[1]

The trial title says the researchers wanted to find and confirm the dose.[1] In simple terms, this means they were checking which dose level could be used for later study and whether the chosen dose gave the expected immune response.[1]

Outcomes measured

The main outcomes focused on safety and immune response.[1] Safety outcomes included local reactions at the injection site, general body symptoms, unwanted adverse events, serious adverse events, adverse events of special interest, and medically attended events.[1]

The study also checked laboratory values in Phase 1 participants, looking for changes from normal or non-significant results before dosing to abnormal results after dosing.[1] This helps researchers see whether the study intervention affects blood tests or chemistry tests in a concerning way.[1]

Immune response outcomes included geometric mean titer (GMT), geometric mean increase, seroconversion rate, and antibody levels for antigen 1 and antigen 2.[1] These measures show how strongly the body made antibodies after vaccination and how many participants had a measurable increase in response.[1]

Trial phase and design

The study was in Phase 1/2.[1] Phase 1 usually focuses more on early safety checks, while Phase 2 looks more closely at immune response and whether the dose seems promising.[1]

The trial was completed, so the planned study period ended and the data collection was finished.[1] The design included multiple vaccine groups and comparator vaccines, which helps researchers compare results across different options.[1]

What the results section would cover

If results are reported for this trial, they would likely describe how many participants had reactions after vaccination, how many had serious problems, and how strong the antibody response was.[1] They would also show whether the study vaccine groups performed differently from the licensed flu vaccine groups.[1]

Because the available source data only gives the study plan and endpoints, this article focuses on what the trial was designed to measure rather than on final effectiveness conclusions.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05823974 Phase 1/2 Healthy volunteers for prevention of influenza infection Completed 1272

FAQ

  • What is being studied in trials of GSKVX000000034797? The trial is studying GSKVX000000034797 as part of an influenza vaccine program. It looks at dose finding, safety, reactogenicity, and immune response.
  • Who can take part in the study? The study includes healthy younger and older adults. It is designed for people without the illness being prevented, because the goal is to study influenza prevention.
  • What phase is the GSKVX000000034797 trial? The study is a Phase 1/2 trial. This means it combines early testing of safety with a broader look at immune response.
  • What outcomes are measured in the trial? The trial measures local and whole-body reactions, unwanted side effects, serious side effects, and lab changes. It also measures antibody levels and seroconversion, which means the change from not having a measurable response to having one.
  • Is GSKVX000000034797 studied alone or with other vaccines? It is studied in different vaccine groups, including groups that contain GSKVX000000034797 and groups that use licensed influenza vaccines as comparators. This helps researchers compare safety and immune response across options.

Ongoing Clinical Trials on GSKVX000000034797

  • Study on the Safety and Immune Response of a New Influenza Vaccine with GSKVX000000034794 in Healthy Younger and Older Adults

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • Influenza: A common viral illness also called the flu. The study is looking at a vaccine approach to help prevent it.
  • Healthy younger and older adults: Adults in different age groups who do not have major health problems. They are used in vaccine studies to see how the body responds.
  • Phase 1/2: An early stage of clinical research. Phase 1 focuses more on safety, and Phase 2 looks more at whether the study vaccine triggers the expected immune response.
  • Safety: How well the study intervention is tolerated and whether serious problems happen during the trial.
  • Reactogenicity: Short-term reactions after vaccination, such as local reactions at the injection site or general symptoms in the body.
  • Immune response: How the body’s defense system reacts after vaccination. In this study, researchers measure antibody responses.
  • Antibody titer: A measure of how much antibody is present in the blood. Higher values can show a stronger immune response.
  • Geometric mean titer (GMT): An average used for antibody levels. It helps compare immune responses across study groups.
  • Seroconversion rate (SCR): The percentage of people who change from no measurable antibody response to a measurable response after vaccination.
  • Adverse event (AE): Any unwanted medical problem seen during a trial, whether or not it is caused by the study vaccine.
  • Serious adverse event (SAE): A more severe unwanted event, such as one that is life-threatening or needs hospital care.
  • Medically attended event (MAE): A health problem that leads to medical care during the study period.

References