Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' influenza vaccine GSK576389A · 1 trial · 1 indication
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade.
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination.
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination.
| Arm | Type | Description |
|---|---|---|
| FluAS25 (GSK576389A) Group | EXPERIMENTAL | Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A). |
| Fluarix Group | ACTIVE_COMPARATOR | Subjects received 1 dose of Fluarix™. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' influenza vaccine GSK576389A | BIOLOGICAL | Single dose, intramuscular injection |
| Fluarix™ | BIOLOGICAL | Single dose, intramuscular injection |
Inclusion Criteria: * Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or GSK576389A vaccines in the 107973 study (NCT00386113). * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the st...
GSK576389A is an investigational influenza vaccine being developed by GSK plc for the prevention of influenza. It is currently in Phase 2 clinical development. The vaccine is intended for use in elderly adults, as studied in a completed clinical trial.
GSK576389A is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is being studied for influenza prevention and is currently in Phase 2 clinical development.
GSK576389A is in Phase 2 clinical development. It is an investigational influenza vaccine, meaning it has not been approved for commercial use. One Phase 2 trial has been completed, and the vaccine is not yet approved by regulatory authorities.
GSK576389A has one completed clinical trial, NCT00538473, titled 'Evaluate Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults.' This Phase 2 study enrolled 68 participants in Belgium and evaluated the vaccine's safety and immunogenicity.
GSK576389A is classified as a monoclonal antibody modality, though it is being developed as an influenza vaccine. It is currently in Phase 2 clinical development for influenza prevention, with one completed trial in elderly adults.