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GSKVX000000039711

Clinical trials are investigating GSKVX000000039711 as part of an influenza vaccine study in healthy younger and older adults. The trials aim to assess safety, reactogenicity, and immune response, including dose finding and confirmation.

Table of Contents

Overview of the trial program

The source data describes one interventional study of GSKVX000000039711 in the setting of influenza vaccine research.[1] The study was designed to find and confirm the dose and to assess safety, reactogenicity, and immune response.[1]

The trial was completed and enrolled 1,272 participants.[1]

Who the study includes

The study focused on healthy younger and older adults.[1] This means the trial did not target people with influenza illness, but rather healthy volunteers taking part in a prevention study.[1]

The condition listed in the source data is prevention of influenza infection.[1] In simple terms, the study aimed to see whether the vaccine approach could help prepare the immune system against flu.[1]

Study phase and purpose

This study was in Phase 1/2.[1] Phase 1/2 means early clinical research that usually starts with careful safety checks and then looks at whether the body makes an immune response.[1]

The brief summary says the study aimed to evaluate the safety and reactogenicity profile of the investigational study intervention and to evaluate the humoral immune response induced by it.[1] Humoral immune response means the response made by antibodies in the blood.[1]

What the trials measure

The main outcomes include local reactions at the injection site and whole-body reactions from Day 1 to Day 7.[1] These are the kinds of early side effects or reactions that are often watched soon after vaccination.[1]

The study also measures unsolicited adverse events from Day 1 to Day 28, serious adverse events from Day 1 to Day 183, adverse events of special interest from Day 1 to Day 183, and medically attended events from Day 1 to Day 183.[1] These terms cover side effects, more serious health problems, special safety concerns, and any event that leads to medical care.[1]

For Phase 1 only, the study checks whether lab results move from a non-clinically significant value at Day 1 to a clinically significant abnormal value at Day 8 and/or Day 29 for hematology and clinical chemistry.[1] Hematology means blood tests, and clinical chemistry means tests that look at substances in the blood, such as those that reflect organ function.[1]

The immune response outcomes include geometric mean titer of antigen 1 and antigen 2 antibody levels at Day 29, geometric mean increase from Day 1 to Day 29, seroconversion rate, and the percentage of participants with antibody levels at or above a cut-off value.[1] These measures help show whether the vaccine makes the body produce more antibodies and how strong that response is.[1]

Study design and comparison groups

The study is listed as interventional, which means participants received a study intervention rather than only being observed.[1] The intervention list includes GSKVX000000039711 and several other study codes, along with comparison vaccines such as Alpharix-Tetra and EFLUELDA.[1]

The source data shows that the study used intramuscular administration, which means the product was given into a muscle.[1] The exact comparison structure is not fully explained in the source, but the presence of multiple vaccine groups suggests the study compared different study formulations and reference vaccines.[1]

Key trial details

NCT05823974 is the trial identifier for this study.[1] The trial was completed and included healthy younger and older adults in a flu prevention setting.[1]

In practical terms, the study was built to answer two main questions: is the vaccine approach safe enough to study further, and does it trigger the immune system in a useful way?[1] The measured outcomes show that researchers were also watching for both short-term and longer-term safety signals.[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 GSKVX000000039711 trials? The trials study GSKVX000000039711 as part of an influenza vaccine research program. They look at safety, how the body reacts, and how well the immune system responds.
  • Who can take part in these trials? The study is in healthy younger and older adults. It is a prevention study, so it does not focus on people who already have influenza infection.
  • What phase is the GSKVX000000039711 trial? This study is in Phase 1/2. That means it is early research that checks safety and immune response while also helping find and confirm the dose.
  • What conditions are these trials focused on? The trials focus on prevention of influenza infection. They are designed to help understand whether the vaccine can protect against flu.
  • What outcomes are measured in the study? The study measures side effects after vaccination, including local and whole-body reactions, as well as immune markers such as antibody levels and seroconversion. It also checks some lab values and more serious safety events over time.

Ongoing Clinical Trials on GSKVX000000039711

  • 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

  • Phase 1/2: An early stage of clinical research. It usually checks safety first and also looks at whether the treatment causes an immune response.
  • Healthy younger and older adults: Adults without the illness being studied. In this trial, both younger and older healthy people are included.
  • Influenza: The flu. It is a common viral infection that can cause fever, cough, and body aches.
  • Reactogenicity: How the body reacts after vaccination, such as pain at the injection site, fever, or tiredness.
  • Immune response: How the body’s defense system responds to a vaccine, often measured by antibodies.
  • Antibody: A protein made by the immune system to help fight infection or respond to a vaccine.
  • Geometric mean titer (GMT): A way to summarize the average level of antibodies in a group of people.
  • Seroconversion rate (SCR): The percentage of people who show a clear rise in antibodies after vaccination.
  • Solicited adverse event: A side effect that the study team asks about in a planned way, usually during a set time after vaccination.
  • Serious adverse event (SAE): A medical problem that is severe, life-threatening, or needs hospital care.