In short
GSKVX000000077508 is an investigational substance being studied as part of an influenza vaccine. It is currently being evaluated in two Phase 3 clinical trials involving adults aged 18 and older. One trial has enrolled 54,000 participants aged 65 and over, while a second trial includes 3,000 adults aged 18 to 64. The trials are designed to test whether the vaccine works as well as existing influenza vaccines and to evaluate its safety.
Key points
- GSKVX000000077508 is an investigational component of an influenza vaccine.
- It is being tested in two Phase 3 trials with a combined enrollment of 57,000 participants.
- One trial focuses on adults aged 65 and older (54,000 participants).
- A second trial studies adults aged 18 to 64 (3,000 participants).
- Both trials are authorised but not yet completed.
- The main goal is to show the vaccine is not inferior to existing influenza vaccines.
What is GSKVX000000077508?
GSKVX000000077508 is an investigational substance that is being studied as a component of a vaccine against influenza, commonly known as the flu. The substance is one of six related investigational components listed in the trial records, which also include GSKVX000000077430, GSKVX000000077506, GSKVX000000077510, GSKVX000000077509, and GSKVX000000077507. These components are being evaluated together as a single vaccine product. The substance is not yet authorised as a medicine and is currently only available within clinical trials.
How does GSKVX000000077508 work?
The trial records describe the investigational product as a vaccine intended to protect against influenza. The vaccine is given by intramuscular injection at a dose of 0.5 millilitres. The studies are designed to measure the immune response generated by the vaccine, including the production of antibodies against influenza virus proteins. One of the trials specifically measures immune responses to two influenza virus proteins called haemagglutinin (HA) and neuraminidase (NA). These proteins are found on the surface of the influenza virus and are the main targets of the immune system after vaccination.
Which conditions is GSKVX000000077508 used or studied for?
- Influenza (flu) in adults aged 65 and older — a Phase 3 trial with 54,000 participants is testing the vaccine in this age group.
- Influenza (flu) in adults aged 18 to 64 — a second Phase 3 trial with 3,000 participants is studying the vaccine in younger adults.
How is GSKVX000000077508 given?
The investigational vaccine containing GSKVX000000077508 is given as an injection into a muscle, known as an intramuscular injection. The dose used in the trials is 0.5 millilitres. No other forms of administration are described in the available trial records.
What do the clinical trials show?
Two Phase 3 clinical trials are currently authorised to study GSKVX000000077508 as part of an investigational influenza vaccine. Both trials are interventional studies, meaning that participants receive the vaccine and are then followed over time. The trials have not yet reported results, so no efficacy or safety findings are available at this stage.
What are the trials measuring?
The larger trial, involving 54,000 adults aged 65 and older, measures how many vaccinated participants develop laboratory-confirmed influenza-like illness caused by specific influenza strains. The strains of interest are influenza A subtypes H1N1 and H3N2, as well as influenza B/Victoria. The trial also records side effects that occur in the first seven days after vaccination, unsolicited adverse events during the first 28 days, and serious adverse events up to the end of the influenza season, with at least 180 days of follow-up.
The second trial, involving 3,000 adults aged 18 to 64, measures the immune response to the vaccine by looking at antibody levels in the blood. Specifically, it measures haemagglutinin inhibition (HI) titers and neuraminidase inhibition (NI) titers at Day 29 after vaccination. It also records solicited side effects during the first seven days, unsolicited adverse events during the first 28 days, and serious adverse events up to six months after vaccination.
Who can take part in these trials?
One trial is open to adults aged 65 years and older. The second trial is open to adults aged 18 to 64 years. Both trials are currently authorised, meaning they have received regulatory approval to proceed, but they may not yet be recruiting participants.
What is the status of the trials?
Both trials are listed as authorised in the EU Clinical Trials Information System (CTIS). This means the trials have been approved by regulatory authorities but have not yet reported results. The trials are Phase 3 studies, which are typically the final stage of testing before a medicine can be submitted for marketing authorisation.