In short
GSKVX000000077510 is an investigational influenza vaccine being studied in adults. It is part of a combination vaccine candidate tested in two phase 3 trials. One trial enrolled 54,000 adults aged 65 and older, and another enrolled 3,000 adults aged 18 to 64. Both trials are authorised and compare the vaccine against an approved high-dose influenza vaccine.
Key points
- GSKVX000000077510 is an investigational influenza vaccine component studied in combination with other antigens.
- Two phase 3 trials are authorised: one in adults ≥65 years with 54,000 participants, one in adults 18–64 years with 3,000 participants.
- The main goal is to show non-inferiority against Efluelda, an approved high-dose trivalent influenza vaccine.
- Key measures include laboratory-confirmed influenza, immune response (HI and NI titers), and safety events.
- Safety is assessed through solicited reactions for 7 days, unsolicited events for 28 days, and serious events for up to 6 months.
- Both trials use intramuscular injection of a 0.5 ml dose.
What is GSKVX000000077510?
GSKVX000000077510 is an investigational influenza vaccine antigen. It is one of several components listed together in the study interventions of two phase 3 trials, alongside GSKVX000000077430, GSKVX000000077508, GSKVX000000077506, GSKVX000000077509 and GSKVX000000077507. The full name GSKVX000000077510 appears only in the registry records; no trade name is given for this component. The vaccine is being developed for prevention of influenza in adults.
How does GSKVX000000077510 work?
The registry records describe the study intervention as a vaccine against influenza. The trials measure immune responses including haemagglutination inhibition (HI) titers and neuraminidase inhibition (NI) titers, which are laboratory tests that assess how well the immune system responds to the influenza virus surface proteins haemagglutinin (HA) and neuraminidase (NA). The records do not provide a detailed mechanism of action for GSKVX000000077510 specifically.
Which conditions is GSKVX000000077510 studied for?
- Influenza, Human — a viral infection of the respiratory tract, commonly called the flu. Both trials aim to prevent laboratory-confirmed influenza caused by specific virus subtypes.
How is GSKVX000000077510 given?
GSKVX000000077510 is given as part of a 0.5 ml suspension for injection by the intramuscular route. The trials compare this investigational vaccine against Efluelda, a high-dose trivalent influenza vaccine (TIV-HD) containing 60 micrograms of haemagglutinin per strain, also given as a 0.5 ml intramuscular injection.
What do the clinical trials show?
Two phase 3 trials are authorised. The first (2026-526682-14-00) is a study on the efficacy of the vaccine in adults aged 65 years and older, with a planned enrollment of 54,000 participants. The second (2026-526925-17-00) evaluates immune response and safety in adults aged 18 to 64 years, with 3,000 participants. The primary objective in both trials is to demonstrate non-inferiority of the investigational vaccine compared to Efluelda in terms of relative efficacy against laboratory-confirmed protocol-defined influenza-like illness caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria.
In the trial in adults 18–64 years, the immune response is measured by HI titers and NI titers at day 29, and by HI seroconversion from baseline to day 29. Safety is evaluated through solicited administration site and systemic events during the 7 days after dosing, unsolicited adverse events during 28 days after dosing, and serious adverse events (SAEs) and adverse events of special interest (AESIs) up to 6 months or the end of the influenza season.
What side effects are known?
The registry records do not report side effect results for GSKVX000000077510. The trials are designed to collect information on solicited administration site and systemic events, unsolicited adverse events, serious adverse events and adverse events of special interest, but no results are yet available in the provided data.