Table of contents

• Trials overview
• Who participated
• What was studied
• Trial phases and study size
• Main endpoints measured
• Safety and reactogenicity
• Study populations and comparators

Trials overview

The trial data show three interventional studies that include GSKVX000000048111 as part of influenza vaccine research.^[1][2][3] These studies were designed to assess immune response and safety in adults and healthy volunteers.^[1][2][3]

Two studies focused on adults 18 years of age and older with influenza, Human as the condition studied.^[1][2] One study focused on healthy younger and older adults and described prevention of influenza infection.^[3]

Who participated

The studies included adults 18 years and older, and one study also included healthy younger and older adults.^[1][2][3] This means the research was not limited to one narrow group, but the exact group depended on the specific trial.^[1][2][3]

All three studies were interventional, which means the researchers gave study vaccines and then measured the results.^[1][2][3]

What was studied

GSKVX000000048111 was studied as part of vaccine groups for influenza, not as a single stand-alone study product.^[1][2][3] The trial records list it with other GSKVX000000 products and with comparator vaccines such as Alpharix, Alpharix-Tetra, and Efluelda, as well as influenza vaccine components described as inactivated split virus or recombinant haemagglutinin.^[1][2][3]

In simple terms, the studies were comparing different influenza vaccine options to see which ones gave the best immune response and acceptable safety results.^[1][2][3]

Trial phases and study size

One study was in Phase 1/2 and two studies were in Phase 2.^[1][2][3] Phase 1/2 studies are early studies that look at safety and the first signs of immune response, while Phase 2 studies look further at safety and how the vaccine performs in a larger group.^[3][1][2]

The reported enrollment was 770 participants in one Phase 2 study, 960 in another Phase 2 study, and 1,272 in the Phase 1/2 study.^[1][2][3] Enrollment means the planned or actual number of people included in the study.^[1][2][3]

Main endpoints measured

The main endpoints were immune response measures and safety measures.^[1][2][3] Endpoints are the main results the researchers plan to measure in a trial.^[1][2][3]

• Antibody titer at Day 29 was measured to see how strong the immune response was after vaccination.^[1][2][3]

• Fold increase in antibody titer from Day 1 to Day 29 showed how much the antibody level rose after the study intervention.^[1][2][3]

• Seroconversion measured whether participants developed a new antibody response after vaccination.^[1][2][3]

• Seroprotection measured whether antibody levels reached a level thought to give protection.^[1][2][3]

The studies also measured changes in antibody levels at Day 1 and Day 29, and in one study also looked at antigen 2 results, not just antigen 1.^[2] This helps researchers compare how the body responds to different vaccine parts.^[2]

Safety and reactogenicity

The studies closely tracked solicited administration site or systemic events, which are expected short-term reactions such as pain where the shot was given or general symptoms like fever.^[1][2]

They also measured 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] These safety checks help show whether any medical problems happened after vaccination and how often they occurred.^[1][2]

One study also measured shifts from non-clinically significant laboratory values on Day 1 to clinically significant abnormal values on Day 8 and/or Day 29 for hematology and clinical chemistry.^[3] Hematology means blood cell tests, and clinical chemistry means blood tests that check body chemicals and organ function.^[3]

Study populations and comparators

The trial records show that GSKVX000000048111 was studied alongside several other influenza vaccine candidates and licensed comparator vaccines.^[1][2][3] Comparators are other vaccines used for comparison, so researchers can judge whether the study vaccine gives similar or better immune responses and safety results.^[1][2][3]

Because the studies included both completed and authorised trials, the trial program appears to be at different stages of development.^[1][2][3] The main focus across the studies stayed the same: immune response and safety in adults and healthy volunteers.^[1][2][3]