In short
GSKVX000000077506 is an investigational vaccine being studied for the prevention of influenza in adults. It is one component of a trivalent influenza vaccine candidate containing three influenza strains, given as a single 0.5 ml intramuscular injection. Two Phase 3 trials are currently authorised, together planning to enrol 57,000 adults aged 18 years and older.
Key points
- GSKVX000000077506 is a component of an investigational trivalent influenza vaccine.
- It is being studied in two Phase 3 trials with a combined planned enrolment of 57,000 participants.
- Both trials are currently authorised but not yet recruiting.
- The larger trial enrols 54,000 adults aged 65 years and older.
- The smaller trial enrols 3,000 adults aged 18 to 64 years.
- Both trials compare the investigational vaccine against Efluelda, a licensed high-dose influenza vaccine.
What is GSKVX000000077506?
GSKVX000000077506 is an investigational influenza vaccine component. It appears in the EU Clinical Trials Information System as one part of a trivalent influenza vaccine candidate, meaning the vaccine contains material from three influenza strains. The substance is listed alongside five related development codes in the trial records, suggesting it belongs to a family of vaccine components being developed together. No marketing authorisation is mentioned in the available data, so this substance is still in the research stage.
How does GSKVX000000077506 work?
The trial records do not state a specific mechanism of action for GSKVX000000077506. As part of an influenza vaccine, it is expected to stimulate an immune response against influenza virus antigens, but the exact target or mechanism is not described in the source data. The trials measure immune responses such as haemagglutination inhibition (HI) titres and neuraminidase inhibition (NI) titres, which are laboratory markers of how well the immune system recognises influenza proteins.
Which conditions is GSKVX000000077506 studied for?
The substance is being studied for the prevention of influenza in humans. Both registered trials list Influenza, Human as the condition under investigation.
How is GSKVX000000077506 given?
The investigational vaccine is given as a single 0.5 ml dose by intramuscular injection. The same route and volume are used for the comparator vaccine Efluelda in both trials.
What do the clinical trials show?
Two Phase 3 trials are registered for this investigational vaccine. Both are currently authorised but have not yet reported results. The larger trial plans to enrol 54,000 adults aged 65 years and older and compares the investigational vaccine against Efluelda, a licensed high-dose trivalent influenza vaccine. The smaller trial plans to enrol 3,000 adults aged 18 to 64 years and compares the investigational vaccine against both Efluelda and a standard trivalent influenza vaccine. The main goal of the larger trial is to show that the investigational vaccine is not inferior to Efluelda in preventing laboratory-confirmed influenza-like illness caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria.
Who can take part in these trials?
The trials enrol adults in two age groups. The larger trial includes adults aged 65 years and older. The smaller trial includes adults aged 18 to 64 years. No further eligibility criteria are described in the registry records.
What are the trials measuring?
The trials measure both efficacy and safety. The larger trial looks at the first occurrence of laboratory-confirmed influenza-like illness at least 14 days after vaccination, caused by specific influenza strains. Both trials record solicited reactions at the injection site and in the whole body during the first 7 days after vaccination, unsolicited adverse events during the first 28 days, and serious adverse events up to the end of the influenza season or 6 months. The smaller trial also measures immune responses by haemagglutination inhibition titres and neuraminidase inhibition titres at day 29.