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GSKVX000000040033

Clinical trials are investigating GSKVX000000040033 as part of an influenza vaccine study in healthy younger and older adults. The trials aim to find and confirm the dose, and to assess safety, reactogenicity, and immune response. They include healthy volunteers and are designed to compare different vaccine options.

Table of Contents

Trial overview

The main study in the source data is NCT05823974, a completed interventional trial of GSKVX000000040033 in healthy younger and older adults.[1] The study title says it was designed to find and confirm the dose and to assess safety, reactogenicity, and immune response for an influenza vaccine.[1]

Who participated

The trial enrolled healthy volunteers, including younger and older adults.[1] The condition listed in the source is prevention of influenza infection, so the study was not for people already sick with influenza.[1]

What was studied

The source data shows that GSKVX000000040033 was studied as part of a vaccine program for influenza prevention.[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 induced.[1] Humoral immune response means the antibody response in the blood.[1]

Trial phase and status

The study was a Phase 1/2 trial, which usually means early testing in people to learn about safety and early signs of immune response.[1] The trial status is listed as Completed.[1] The enrollment was 1272 participants.[1]

Endpoints and what they mean

The trial measured several safety outcomes, including solicited administration site events and solicited systemic events from Day 1 to Day 7.[1] Solicited events are side effects that researchers ask about on purpose after vaccination, such as pain where the shot was given or body-wide symptoms like fever or tiredness.[1]

The study also measured 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] These terms mean, respectively, any extra unwanted health problem reported by the participant, severe medical problems, side effects that need special monitoring, and health problems that lead to medical care.[1]

For laboratory safety, the Phase 1 part of the study checked whether a non-clinically significant lab value on Day 1 changed to a clinically significant abnormal value on Day 8 and/or Day 29 for hematology and clinical chemistry.[1] Hematology means blood tests, and clinical chemistry means tests that measure substances in the blood such as salts, sugar, and organ-related markers.[1]

The immune response outcomes included geometric mean titer (GMT), geometric mean increase (GMI), seroconversion rate (SCR), and the percentage of participants with antibody levels above a cut-off value at Day 1 and Day 29.[1] These results were reported for antigen 1 and antigen 2, showing that the study looked at how strongly the immune system responded to more than one vaccine target.[1]

Comparators and study design

The intervention list shows that the study included GSKVX000000040033 in different vaccine combinations and also compared it with licensed influenza vaccines such as Alpharix-Tetra and EFLUELDA.[1] This kind of comparison helps researchers see how the investigational vaccine performs against existing vaccines in healthy adults.[1]

The source data does not provide more details about randomization, masking, or exact dose groups, so those points are not described here.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05823974 Phase 1/2 Prevention of influenza infection in healthy younger and older adults Completed 1272

FAQ

  • What is being studied in the trials of GSKVX000000040033? The trials are studying GSKVX000000040033 as part of an influenza vaccine program. They look at dose finding, safety, and how well the vaccine triggers an immune response.
  • Who can take part in these trials? The study includes healthy younger and older adults. The source data describes the target group as healthy volunteers.
  • What phase is the GSKVX000000040033 trial? This trial is in Phase 1/2. That means it is an early study that looks at both safety and early signs of immune response.
  • What conditions are being studied? The trial is focused on prevention of influenza infection. It is part of research on an influenza vaccine.
  • What outcomes are measured in the trial? The study measures side effects, including local and whole-body reactions, as well as immune response results such as antibody levels and seroconversion. Seroconversion means a change showing the body has made a stronger antibody response.

Ongoing Clinical Trials on GSKVX000000040033

  • 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

  • Clinical trial: A research study in people that tests a medical product or vaccine to learn about safety, immune response, and how well it works.
  • Interventional study: A study where participants receive a study treatment or vaccine so researchers can measure its effects.
  • Phase 1/2: An early stage of research that checks safety first and also looks for early signs that the vaccine may work.
  • Healthy volunteers: People without the disease being studied who join a trial to help researchers test a vaccine or treatment.
  • Reactogenicity: The short-term reactions after vaccination, such as pain at the injection site, fever, or tiredness.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the study treatment.
  • Serious adverse event: A medical problem that is severe, such as one that is life-threatening, causes hospital care, or leads to major harm.
  • Adverse event of special interest: A side effect that researchers watch very closely because it may be especially important for the study.
  • Medically attended event: A health problem that leads a participant to seek medical care.
  • Antibody titer: A measure of how much antibody is in the blood. Higher levels often mean a stronger immune response.
  • Geometric mean titer (GMT): An average way to report antibody levels in a group of people.
  • Seroconversion rate (SCR): The percentage of participants whose blood shows a clear rise in antibodies after vaccination.

References