In short
Clinical trials investigating GSKVX000000048110 are studying influenza vaccines in adults, including healthy younger and older adults and adults 18 years and older. These trials look at immune response, safety, and reactogenicity, which means how often side effects happen after vaccination. The studies are in Phase 1/2 and Phase 2.
Key points
- Clinical trials investigating GSKVX000000048110 are focused on influenza vaccines in adults. The studies include healthy younger and older adults, adults 18 years and older, and healthy volunteers. Researchers are looking at how well the vaccine candidates trigger antibodies and how safe they are. The trials are in Phase 1/2 and Phase 2. Main outcomes include antibody levels, seroconversion, seroprotection, and different kinds of side effects and lab changes. Three trials are listed in the source data, with two completed studies and one authorised study.
Trial overview
Clinical trials with GSKVX000000048110 are studying influenza vaccine candidates in adults. The trial data show studies in adults 18 years and older, healthy younger and older adults, and healthy volunteers for prevention of influenza infection.
All listed studies are interventional, which means researchers give a study intervention and then measure the results. The conditions studied are related to human influenza.
Who can participate
One study includes adults 18 years of age and older. Another study includes healthy younger and older adults. The third study includes healthy volunteers and focuses on prevention of influenza infection.
These are vaccine studies, so the source data point to people who are well enough to join a vaccination trial rather than people being treated for active influenza illness.
What the trials measure
The main goal is to see how strongly the body makes antibodies after vaccination, also called the humoral immune response. Antibodies are proteins made by the immune system that can help fight infection.
Researchers measure antibody titer at Day 29, the fold increase from Day 1 to Day 29, seroconversion from Day 1 to Day 29, and seroprotection at Day 1 and Day 29. In the Phase 1/2 study, they also measure geometric mean titer, geometric mean increase, and antigen 2 responses.
Safety is also a major focus. The trials record solicited administration site events and systemic events within 7 days, 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.
Trial phases and status
The source data list two Phase 2 studies and one Phase 1/2 study. Phase 1/2 means the study is looking at early safety and also beginning to check immune response in a larger group.
One Phase 2 study is authorised and has 960 planned participants. Another Phase 2 study is completed with 770 participants. The Phase 1/2 study is completed with 1272 participants.
Trial summary
Across the three studies, GSKVX000000048110 appears in influenza vaccine combinations that are compared with other influenza vaccine options listed in the trial records. The studies are designed to learn whether the vaccine candidates can produce a good immune response and whether they are well tolerated after injection.
Because the trials focus on antibodies and safety checks, they are typical vaccine research studies rather than treatment studies for active disease.
Key patient terms
- Humoral immune response: the part of the immune response that uses antibodies to help protect the body.
- Seroconversion: a change showing that antibody response has risen after vaccination.
- Seroprotection: an antibody level that is thought to give protection.
- Reactogenicity: the short-term reactions that happen after a vaccine, such as local or general symptoms.
- Adverse event: any unwanted health problem that happens during a study.
- Serious adverse event: a severe health problem that needs close attention.