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GSKVX000000034794

Clinical trials are investigating GSKVX000000034794 in influenza vaccine studies. These trials look at immune response, safety, and reactogenicity in healthy adults and adults 18 years and older. The studies compare different vaccine versions and measure how well they work and how well they are tolerated.

Table of Contents

Trial overview

GSKVX000000034794 is being studied in clinical trials for influenza, also called the flu.[1][2][3] The trial data shows three interventional studies with different sizes, and all of them focus on vaccine research in adults or healthy volunteers.[1][2][3]

Two studies are in Phase 2, and one study is in Phase 1/2.[1][2][3] The studies are completed or authorised, and they use intramuscular vaccination, which means the vaccine is given into a muscle.[1][2][3]

Who is studied in these trials

One trial includes adults 18 years of age and older, while another includes healthy younger and older adults.[1][2] The third study is in healthy volunteers for prevention of influenza infection.[3]

  • Adults 18 years and older: These participants are old enough to join adult vaccine studies and are used to test immune response and safety.[1][2]

  • Healthy younger and older adults: This group helps researchers see how the vaccine works across different adult age ranges.[3]

  • Healthy volunteers: These are people who do not have influenza infection and join to help study prevention.[3]

Trial phases and study design

The studies are interventional, which means participants receive a study vaccine or a comparison vaccine so researchers can compare results.[1][2][3] A Phase 1/2 study usually looks at early safety and immune response and may help find the dose, while Phase 2 studies continue testing in larger groups.[1][3]

The enrollment sizes are 770, 960, and 1272 participants, which shows that these are fairly large vaccine studies.[1][2][3] One Phase 1/2 study is described as a dose-finding study, meaning it tries to find and confirm the best dose before moving further.[3]

What the trials measure

The main goal across the studies is to measure the humoral immune response, which means the antibody response in the blood after vaccination.[1][2][3] The studies also check safety and reactogenicity, which means short-term reactions after the vaccine is given.[1][2][3]

  • Antibody titer: Researchers measure antibody levels on Day 29 to see how strong the immune response is.[1][2][3]

  • Fold increase or geometric mean increase: This shows how much antibody levels rise from Day 1 to Day 29.[1][2][3]

  • Seroconversion: This measures how many participants show a clear new antibody response after vaccination.[1][2][3]

  • Seroprotection: This checks whether antibody levels reach a level considered protective in the study.[1][2]

  • Solicited events: These are expected reactions, such as injection-site or body-wide symptoms, tracked for 7 days after vaccination.[1][2][3]

  • Unsolicited adverse events: These are other health problems reported within 28 days after vaccination.[1][2][3]

  • Serious adverse events, adverse events of special interest, and medically attended events: These are tracked for up to 6 months to monitor more important safety outcomes.[1][2][3]

  • Laboratory abnormalities: Blood test changes are checked before dosing and after vaccination on Day 3, Day 8, and Day 29 in the studies that report this outcome.[1][2][3]

Comparison vaccines and study groups

The studies do not test GSKVX000000034794 alone in every group.[1][2][3] They compare it with other influenza vaccine products, including Alpharix, Alpharix-Tetra, EFLUELDA, and influenza vaccines described as inactivated split virus or recombinant haemagglutinin vaccines.[1][2][3]

Some trial arms include GSKVX000000034794 together with other GSKVX study codes, such as GSKVX000000034798, GSKVX000000048110, GSKVX000000048111, and other related candidates.[1][2][3] This setup helps researchers compare different vaccine versions and combinations within the same influenza program.[1][2][3]

What the results aim to show

Across the studies, the main aim is to find out whether the vaccine candidates can trigger a useful antibody response and whether they have an acceptable safety profile.[1][2][3] The studies also look for the best dose in the Phase 1/2 trial and check how the immune response changes over time in adults.[3]

Because the trials focus on adults and healthy volunteers, the results are meant to help understand influenza vaccine performance in people who are being studied before broader use.[1][2][3]

Trial IDPhaseCondition studiedStatusEnrollment
2025-522278-35-00Phase 2Influenza, HumanCompleted770
NCT07204964Phase 2Influenza, HumanAuthorised960
NCT05823974Phase 1/2Healthy volunteers (prevention of influenza infection)Completed1272

FAQ

  • What is being studied in trials of GSKVX000000034794? These trials study influenza vaccine candidates that include GSKVX000000034794. The main goals are to measure immune response, safety, and reactogenicity, which means how often short-term reactions happen after vaccination.
  • Who can take part in these studies? The trial data includes healthy younger and older adults, as well as adults 18 years of age and older. The studies are focused on people who are being vaccinated to help prevent influenza.
  • What phases are the GSKVX000000034794 trials? The studies are in Phase 1/2 and Phase 2. Phase 1/2 studies usually look at early safety and immune response, while Phase 2 studies continue this testing in larger groups.
  • What conditions are these trials related to? All of the trials in the data are related to influenza, also called the flu. One study description also says the vaccine is for prevention of influenza infection in healthy volunteers.
  • What outcomes are measured in these trials? The trials measure antibody levels, antibody rise over time, seroconversion, and seroprotection. They also track site reactions, systemic symptoms, adverse events, serious adverse events, and laboratory abnormalities.

Ongoing Clinical Trials on GSKVX000000034794

  • Study of mRNA-based seasonal influenza vaccine to evaluate immune response and safety in adults 18 years and older

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study of mRNA-based seasonal influenza vaccine combinations compared to standard influenza vaccines in adults aged 18 and older

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • 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 viral infection also called the flu. These trials study vaccines meant to help prevent it.
  • Healthy volunteers: People without the condition being treated, who join a study to help test a vaccine or treatment.
  • Phase 1/2: An early study stage that looks at safety and immune response, and may also help choose the best dose.
  • Phase 2: A study stage that usually includes more people than early trials and continues to test safety and immune response.
  • Interventional study: A study where participants receive a study vaccine or comparison vaccine so researchers can measure results.
  • Immune response: How the body’s defense system reacts after vaccination, often measured by antibody levels.
  • Antibody titer: A measurement of how many antibodies are in the blood. Higher levels can show a stronger response.
  • Seroconversion: A change in blood test results that shows the body has started making a noticeable antibody response.
  • Seroprotection: A blood test result that suggests the antibody level may be high enough to help protect against infection.
  • Reactogenicity: Short-term reactions after vaccination, such as local or body-wide symptoms.
  • Adverse event: Any unwanted health problem that happens during a study, whether or not it is caused by the vaccine.
  • Serious adverse event: A more serious health problem, such as one that is life-threatening, causes hospital care, or has major medical impact.

References