GSKVX000000039711 Clinical Trials in Healthy Adults for Influenza Vaccine Research

Overview of the trial program

The source data describes one interventional study of GSKVX000000039711 in the setting of influenza vaccine research.¹ The study was designed to find and confirm the dose and to assess safety, reactogenicity, and immune response.¹

The trial was completed and enrolled 1,272 participants.¹

Who the study includes

The study focused on healthy younger and older adults.¹ This means the trial did not target people with influenza illness, but rather healthy volunteers taking part in a prevention study.¹

The condition listed in the source data is prevention of influenza infection.¹ In simple terms, the study aimed to see whether the vaccine approach could help prepare the immune system against flu.¹

Study phase and purpose

This study was in Phase 1/2.¹ Phase 1/2 means early clinical research that usually starts with careful safety checks and then looks at whether the body makes an immune response.¹

The brief summary says the study aimed to evaluate the safety and reactogenicity profile of the investigational study intervention and to evaluate the humoral immune response induced by it.¹ Humoral immune response means the response made by antibodies in the blood.¹

What the trials measure

The main outcomes include local reactions at the injection site and whole-body reactions from Day 1 to Day 7.¹ These are the kinds of early side effects or reactions that are often watched soon after vaccination.¹

The study also measures unsolicited adverse events from Day 1 to Day 28, serious adverse events from Day 1 to Day 183, adverse events of special interest from Day 1 to Day 183, and medically attended events from Day 1 to Day 183.¹ These terms cover side effects, more serious health problems, special safety concerns, and any event that leads to medical care.¹

For Phase 1 only, the study checks whether lab results move from a non-clinically significant value at Day 1 to a clinically significant abnormal value at Day 8 and/or Day 29 for hematology and clinical chemistry.¹ Hematology means blood tests, and clinical chemistry means tests that look at substances in the blood, such as those that reflect organ function.¹

The immune response outcomes include geometric mean titer of antigen 1 and antigen 2 antibody levels at Day 29, geometric mean increase from Day 1 to Day 29, seroconversion rate, and the percentage of participants with antibody levels at or above a cut-off value.¹ These measures help show whether the vaccine makes the body produce more antibodies and how strong that response is.¹

Study design and comparison groups

The study is listed as interventional, which means participants received a study intervention rather than only being observed.¹ The intervention list includes GSKVX000000039711 and several other study codes, along with comparison vaccines such as Alpharix-Tetra and EFLUELDA.¹

The source data shows that the study used intramuscular administration, which means the product was given into a muscle.¹ The exact comparison structure is not fully explained in the source, but the presence of multiple vaccine groups suggests the study compared different study formulations and reference vaccines.¹

Key trial details

NCT05823974 is the trial identifier for this study.¹ The trial was completed and included healthy younger and older adults in a flu prevention setting.¹

In practical terms, the study was built to answer two main questions: is the vaccine approach safe enough to study further, and does it trigger the immune system in a useful way?¹ The measured outcomes show that researchers were also watching for both short-term and longer-term safety signals.¹