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GSKVX000000048110

Clinical trials investigating GSKVX000000048110 are studying influenza vaccines in adults, including healthy younger and older adults and adults 18 years and older. These trials look at immune response, safety, and reactogenicity, which means how often side effects happen after vaccination. The studies are in Phase 1/2 and Phase 2.

Table of contents

Trial overview

Clinical trials with GSKVX000000048110 are studying influenza vaccine candidates in adults.[1] The trial data show studies in adults 18 years and older, healthy younger and older adults, and healthy volunteers for prevention of influenza infection.[1][2][3]

All listed studies are interventional, which means researchers give a study intervention and then measure the results.[1][2][3] The conditions studied are related to human influenza.[1][2][3]

Who can participate

One study includes adults 18 years of age and older.[1] Another study includes healthy younger and older adults.[3] The third study includes healthy volunteers and focuses on prevention of influenza infection.[3]

These are vaccine studies, so the source data point to people who are well enough to join a vaccination trial rather than people being treated for active influenza illness.[2][3]

What the trials measure

The main goal is to see how strongly the body makes antibodies after vaccination, also called the humoral immune response.[1][2][3] Antibodies are proteins made by the immune system that can help fight infection.

Researchers measure antibody titer at Day 29, the fold increase from Day 1 to Day 29, seroconversion from Day 1 to Day 29, and seroprotection at Day 1 and Day 29.[1][2] In the Phase 1/2 study, they also measure geometric mean titer, geometric mean increase, and antigen 2 responses.[3]

Safety is also a major focus.[1][2][3] The trials record solicited administration site events and systemic events within 7 days, unsolicited adverse events within 28 days, serious adverse events within 6 months, adverse events of special interest within 6 months, medically attended adverse events within 6 months, and laboratory abnormalities after dosing.[1][2][3]

Trial phases and status

The source data list two Phase 2 studies and one Phase 1/2 study.[1][2][3] Phase 1/2 means the study is looking at early safety and also beginning to check immune response in a larger group.

One Phase 2 study is authorised and has 960 planned participants.[1] Another Phase 2 study is completed with 770 participants.[2] The Phase 1/2 study is completed with 1272 participants.[3]

Trial summary

Across the three studies, GSKVX000000048110 appears in influenza vaccine combinations that are compared with other influenza vaccine options listed in the trial records.[1][2][3] The studies are designed to learn whether the vaccine candidates can produce a good immune response and whether they are well tolerated after injection.[1][2][3]

Because the trials focus on antibodies and safety checks, they are typical vaccine research studies rather than treatment studies for active disease.[1][2][3]

Key patient terms

  • Humoral immune response: the part of the immune response that uses antibodies to help protect the body.[1][2][3]
  • Seroconversion: a change showing that antibody response has risen after vaccination.[1][2]
  • Seroprotection: an antibody level that is thought to give protection.[1][2]
  • Reactogenicity: the short-term reactions that happen after a vaccine, such as local or general symptoms.[1][2][3]
  • Adverse event: any unwanted health problem that happens during a study.[1][2][3]
  • Serious adverse event: a severe health problem that needs close attention.[1][2][3]
Trial ID Phase Condition studied Status Enrollment
NCT07204964 Phase 2 Influenza, Human Authorised 960
2025-522278-35-00 Phase 2 Influenza, Human Completed 770
NCT05823974 Phase 1/2 Healthy volunteers (prevention of influenza infection) Completed 1272

FAQ

  • What are the clinical trials of GSKVX000000048110 studying? They are studying influenza vaccine candidates that include GSKVX000000048110. The main goals are to measure immune response, safety, and reactogenicity after vaccination.
  • Who can take part in these trials? The trials include healthy younger and older adults, and adults 18 years of age and older. One study also focuses on healthy volunteers for prevention of influenza infection.
  • What trial phases are listed for GSKVX000000048110? The trials are in Phase 1/2 and Phase 2. This means researchers are both checking early safety and looking more closely at immune response.
  • What conditions are being studied? The studies are focused on human influenza. One trial also describes prevention of influenza infection in healthy volunteers.
  • What outcomes do the trials measure? They measure antibody levels, seroconversion, and seroprotection, which show how the immune system responds. They also track side effects, serious adverse events, and lab changes after vaccination.

Ongoing Clinical Trials on GSKVX000000048110

  • 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 often called the flu. These trials study vaccines meant to prevent it.
  • Immune response: How the body’s defense system reacts after vaccination, often measured by antibody levels.
  • Antibody titer: A blood test result that shows how much antibody is present. Higher levels can mean a stronger response.
  • Seroconversion: A change from little or no antibody response to a measurable response after vaccination.
  • Seroprotection: A blood level of antibodies that is thought to give protection.
  • Reactogenicity: How often expected short-term reactions happen after vaccination, such as local or body-wide symptoms.
  • Solicited adverse events: Side effects that researchers ask about on purpose during a set time after vaccination.
  • Unsolicited adverse events: Any side effects that are reported but were not specifically asked about.
  • Serious adverse events: Health problems that are severe and may need urgent medical care or lead to major harm.
  • AESIs: Adverse events of special interest, meaning side effects that researchers watch especially closely.
  • MAAEs: Medically attended adverse events, meaning side effects that lead to a healthcare visit.
  • Geometric mean titer (GMT): An average antibody level used in vaccine studies because it handles wide ranges of values better than a simple average.

References