In short
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.
Key points
- Clinical trials of GSKVX000000070965 are studying influenza in adults 18 years and older. The main goals are to measure the body’s immune response and to check safety. The trial is Phase 2 and includes 960 participants. Researchers are measuring antibody levels, seroconversion, seroprotection, and different kinds of side effects after vaccination. The available trial data show a study focused on how well the vaccine works and how well it is tolerated.
Trial overview
NCT07204964 is an interventional study, which means researchers give a study treatment and then observe the results. It is testing GSKVX000000070965 in adults 18 years of age and older with influenza, human.
The study title says it is designed to assess the immune response and safety of an influenza vaccine. The brief summary also says the trial aims to evaluate the humoral immune response, which is the antibody response in the blood.
Who can participate
The trial is for adults 18 years of age and older. The condition listed is influenza, human, so the study is focused on people in that disease area.
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.
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. These are standard ways to see whether the vaccine has helped the body build a measurable immune response.
The study also checks antibody titer at Day 1 and Day 29, which helps compare the blood response before and after the study intervention. In simple terms, the researchers want to know whether the immune response gets stronger after vaccination.
Safety checks and follow-up
The trial records solicited administration site or systemic events within 7 days. Solicited events are side effects the study specifically asks people about, and they can happen at the injection site or affect the whole body.
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. These terms mean the researchers are watching for both common and more important health problems after the study intervention.
In addition, the study checks for laboratory abnormalities before dosing on Day 1 and after dosing on Day 3, Day 8, and Day 29. This helps the team see whether the study treatment is linked to any changes in blood or other lab tests.
Trial status and phase
The trial status is listed as Authorised. 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.
The enrollment is 960 participants, which shows this is a fairly large vaccine study. The interventions listed include GSKVX000000070965 and several other study vaccine codes, along with comparator influenza vaccines used to compare immune response and safety.