Table of contents
- Overview of the trial program
- Who the study is for
- Study design and phase
- What the researchers measured
- Comparison vaccines and study groups
- What the trial record shows
- Simple explanation of key terms
Overview of the trial program
The clinical trial record for GSKVX000000034795 describes a study to find and confirm the dose and to assess safety, reactogenicity, and immune response in an influenza vaccine setting.[1] The study is focused on prevention of influenza infection in healthy adults.[1]
Who the study is for
The trial enrolled healthy younger and older adults, and the source data also describes the population as healthy volunteers.[1] This means the study was not designed for people already sick with influenza, but for people without the disease who could help researchers evaluate a vaccine candidate.[1]
Study design and phase
This was an interventional study, which means researchers gave study products to participants and then measured the results.[1] The trial was in Phase 1/2, an early stage of research that usually checks safety first and then looks more closely at immune response and dosing.[1] The study was reported as completed and included 1,272 participants.[1]
What the researchers measured
The main safety outcomes included the percentage of participants reporting solicited administration site events from Day 1 to Day 7, such as reactions at the injection site.[1] The study also measured solicited systemic events from Day 1 to Day 7, which are body-wide symptoms after vaccination.[1]
Researchers tracked 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] In Phase 1 only, the study also checked whether laboratory results changed from not clinically significant at baseline to clinically significant abnormal values after dosing on Day 8 and/or Day 29 for hematology and clinical chemistry.[1]
For immune response, the trial measured geometric mean titer of antigen 1 and antigen 2 antibodies on Day 29, geometric mean increase from Day 1 to Day 29, seroconversion rate, and the percentage of participants with antibody levels above a cut-off value.[1] These endpoints help show whether the vaccine candidate triggered an antibody response.[1]
Comparison vaccines and study groups
The intervention list shows that GSKVX000000034795 was studied among several related investigational vaccine candidates, including groups with combinations of GSKVX numbers and intramuscular administration.[1] The trial also included comparator influenza vaccines such as Alpharix-Tetra and EFLUELDA.[1] These comparison groups help researchers judge how the study product performs against other influenza vaccines.[1]
What the trial record shows
The record identifies one completed trial: NCT05823974.[1] Its purpose was to evaluate the safety and reactogenicity profile of the investigational intervention and to evaluate the humoral immune response, which means the antibody response in the blood.[1] The available data do not provide detailed numerical results in the source text, but they do clearly show the study goals, population, phase, and endpoints.[1]
Simple explanation of key terms
Safety means whether the study product causes unwanted medical problems.[1] Reactogenicity means the short-term reactions that can happen after vaccination, especially around the injection site or as general symptoms.[1]
Humoral immune response means the antibody response made by the body after vaccination.[1] Clinical chemistry and hematology are blood-test areas used to check general health and safety during a study.[1]
Seroconversion means a participant develops a measurable antibody response after vaccination.[1] Geometric mean titer is a standard way to summarize antibody levels across a group of participants.[1]
