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GSKVX000000070965

Clinical trials are studying GSKVX000000070965 in adults 18 years and older. These trials aim to measure immune response, safety, and reactogenicity, which means how often short-term side effects happen after vaccination. The study is for people with influenza, human.

Table of Contents

Trial overview

NCT07204964 is an interventional study, which means researchers give a study treatment and then observe the results.[1] It is testing GSKVX000000070965 in adults 18 years of age and older with influenza, human.[1]

The study title says it is designed to assess the immune response and safety of an influenza vaccine.[1] The brief summary also says the trial aims to evaluate the humoral immune response, which is the antibody response in the blood.[1]

Who can participate

The trial is for adults 18 years of age and older.[1] The condition listed is influenza, human, so the study is focused on people in that disease area.[1]

The source data do not give a full list of inclusion or exclusion rules, so it is not possible to say more about who can join beyond the age group and condition shown.[1]

What is being measured

The main outcome measures focus on antibody titer at Day 29, the fold increase from Day 1 to Day 29, seroconversion, and seroprotection.[1] These are standard ways to see whether the vaccine has helped the body build a measurable immune response.[1]

The study also checks antibody titer at Day 1 and Day 29, which helps compare the blood response before and after the study intervention.[1] In simple terms, the researchers want to know whether the immune response gets stronger after vaccination.[1]

Safety checks and follow-up

The trial records solicited administration site or systemic events within 7 days.[1] Solicited events are side effects the study specifically asks people about, and they can happen at the injection site or affect the whole body.[1]

It also tracks unsolicited adverse events within 28 days, serious adverse events within 6 months, adverse events of special interest within 6 months, and medically attended adverse events within 6 months.[1] These terms mean the researchers are watching for both common and more important health problems after the study intervention.[1]

In addition, the study checks for laboratory abnormalities before dosing on Day 1 and after dosing on Day 3, Day 8, and Day 29.[1] This helps the team see whether the study treatment is linked to any changes in blood or other lab tests.[1]

Trial status and phase

The trial status is listed as Authorised.[1] It is a Phase 2 study, which usually means the treatment is being tested in a larger group to learn more about immune response and safety.[1]

The enrollment is 960 participants, which shows this is a fairly large vaccine study.[1] The interventions listed include GSKVX000000070965 and several other study vaccine codes, along with comparator influenza vaccines used to compare immune response and safety.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07204964 Phase 2 Influenza, Human Authorised 960

FAQ

  • What is being studied in trials of GSKVX000000070965? The trials are studying how well GSKVX000000070965 helps the body make an immune response against influenza. They also look at safety and how often short-term reactions happen after vaccination.
  • Who can take part in these trials? The trial shown here is for adults 18 years of age and older. It is focused on people with human influenza.
  • What phase is the trial of GSKVX000000070965? The trial is in Phase 2. This means it is mainly checking immune response and safety in a larger group than early testing.
  • What results are measured in the study? The study measures antibody titer, which is the amount of antibodies in the blood, and how much it increases after vaccination. It also checks seroconversion and seroprotection, which are signs that the immune response has changed in a helpful way.
  • What safety information is collected? The trial records local and body-wide reactions within 7 days, other unwanted side effects within 28 days, and serious or medically important events for up to 6 months. It also checks lab test changes after the study intervention.

Ongoing Clinical Trials on GSKVX000000070965

  • 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

Glossary

  • Antibody titer: A measure of how much antibody is present in the blood. A higher titer can mean a stronger immune response.
  • Seroconversion: A change in blood test results showing that the body has started making a clear immune response after vaccination.
  • Seroprotection: A blood test result that suggests the level of antibodies may be high enough to help protect against infection.
  • Humoral immune response: The part of the immune system that makes antibodies in the blood.
  • Reactogenicity: How often short-term reactions happen after a vaccine, such as pain at the injection site or fever.
  • Solicited events: Side effects that the study specifically asks people to report after treatment.
  • Unsolicited adverse events: Any unwanted medical problems that happen after treatment, even if they were not specifically asked about.
  • Serious adverse events: Medical problems that are severe, life-threatening, or need hospital care.
  • Adverse events of special interest: Side effects that the researchers are watching very closely because they are especially important for the study.
  • Medically attended adverse events: Health problems that lead a person to see a doctor or get medical care.

References