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GSKVX000000070248

Clinical trials are investigating GSKVX000000070248 as part of influenza vaccine studies in adults 18 years and older. These trials look at immune response, safety, and reactogenicity, which means how often short-term reactions happen after vaccination. They compare different study vaccine groups and other influenza vaccines.

Table of contents

Trial overview

Two Phase 2 interventional studies are investigating GSKVX000000070248 in the setting of influenza vaccination in adults.[1][2] Both trials focus on influenza, human and are designed to evaluate immune response and safety.[1][2]

The brief summaries for both studies say the same main goals: to evaluate the humoral immune response and the safety and reactogenicity profile of the study interventions.[1][2] Humoral immune response means the antibody response in the blood.[1][2]

Who was studied

The target population in both trials is adults 18 years of age and older.[1][2] The trial data do not provide more detailed entry rules, so the main known group is adults in this age range.[1][2]

These studies are not described as pediatric trials, and no child or adolescent group is listed in the source data.[1][2]

What the trials measured

The main immune measures include antigen 1 antibody titer at Day 29, the fold increase in antibody titer from Day 1 to Day 29, seroconversion from Day 1 to Day 29, and seroprotection at Day 1 and Day 29.[1][2] These outcomes help show whether the vaccine study group raised antibody levels after vaccination.[1][2]

The safety measures include solicited administration site or 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 any laboratory abnormalities before dosing and after dosing on Day 3, Day 8, and Day 29.[1][2]

In simple terms, the studies watch both how the body responds and how often unwanted health events happen after vaccination.[1][2]

Trial status and size

One trial, 2025-522278-35-00, is listed as Completed and enrolled 770 participants.[1] The other trial, NCT07204964, is listed as Authorised and planned for 960 participants.[2]

Both studies are Phase 2, which means they are beyond the earliest testing stage and are looking more closely at immune response and safety in a defined adult group.[1][2]

Study comparators

The trial records show that GSKVX000000070248 was studied alongside other influenza vaccine products and study vaccine groups.[1][2] The listed comparators include Alpharix trivalent influenza vaccine, inactivated split virus influenza vaccines, and recombinant hemagglutinin influenza vaccines.[1][2]

These comparisons help researchers see how the study vaccine groups perform against other influenza vaccine options, but the source data do not give final head-to-head results.[1][2]

Patient-friendly terms

Antibody means a protein made by the immune system to help fight infection.[1][2] Seroconversion means the blood test changes in a way that shows a new or stronger antibody response after vaccination.[1][2]

Seroprotection means the antibody level is thought to be high enough to help protect against flu.[1][2] Reactogenicity means the expected short-term reactions after a vaccine, such as pain at the injection site or other body-wide symptoms.[1][2]

Adverse event is a medical problem that happens during a study, whether or not it is caused by the study vaccine.[1][2] Serious adverse event is a more severe problem that can need urgent care or hospital treatment.[1][2]

Trial ID Phase Condition studied Status Enrollment
2025-522278-35-00 Phase 2 Influenza, human Completed 770
NCT07204964 Phase 2 Influenza, human Authorised 960

FAQ

  • What is being studied in the GSKVX000000070248 trials? The trials are studying immune response and safety in influenza vaccine studies. They measure how well the vaccine triggers antibodies and how often side effects or reactions happen.
  • Who can take part in these trials? The target population is adults 18 years of age and older. The trial data do not give more detailed joining rules.
  • What phase are the GSKVX000000070248 trials? Both trials are Phase 2 studies. Phase 2 trials usually look more closely at how well a vaccine works and how safe it is in a larger group than early testing.
  • What condition is being studied? The condition studied is influenza, human. This means the trials focus on flu prevention in adults.
  • What do the trials measure? They measure antibody titer, fold increase in antibodies, seroconversion, and seroprotection. They also track site reactions, systemic events, serious adverse events, and lab abnormalities.

Ongoing Clinical Trials on GSKVX000000070248

  • 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

Glossary

  • Influenza, human: The flu in people. It is a contagious viral infection that can cause fever, cough, sore throat, and body aches.
  • Adult 18 years and older: People who are at least 18 years old. This is the age group the trials are designed for.
  • Phase 2: A mid-stage clinical trial. It looks at immune response and safety in more people than early studies.
  • Interventional study: A study where researchers give a study treatment or vaccine and then measure the results.
  • Antibody titer: A blood test result that shows how much antibody is present. Antibodies are proteins the body makes to fight infection.
  • Seroconversion: A change from no measurable antibody response to a measurable one, or a clear rise in antibodies after vaccination.
  • Seroprotection: A blood level of antibodies that is thought to give protection against infection.
  • Reactogenicity: The usual short-term reactions after a vaccine, such as pain at the injection site or fever.
  • Solicited events: Side effects that researchers ask about on purpose, often because they are expected after vaccination.
  • Unsolicited adverse events: Any health problem reported during the study that was not specifically asked about.
  • Serious adverse events: Health problems that are severe, life-threatening, cause hospital care, or have major medical impact.
  • Laboratory abnormalities: Test results outside the normal range, such as blood test changes before or after vaccination.

References