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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...
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GSK Biologicals' influenza vaccine GSK576389A is an investigational vaccine developed by GSK plc for the prevention of influenza. It is a Phase 2 candidate studied in elderly adults. The vaccine has been evaluated in a single completed clinical trial that enrolled 68 participants in Belgium.
GSK Biologicals' influenza vaccine GSK576389A is being developed for the prevention of influenza. Its clinical evaluation has focused on elderly adults, specifically those aged 67 years and older. The vaccine remains investigational and has not been approved for use.
GSK Biologicals' influenza vaccine GSK576389A is made by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK Biologicals is the vaccine division of GSK plc and is responsible for the development of this influenza vaccine candidate.
GSK Biologicals' influenza vaccine GSK576389A is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA or any regulatory authority. The only recorded trial for this candidate is completed, and no active trials are currently listed.
GSK Biologicals' influenza vaccine GSK576389A has been studied in one completed Phase 2 trial, NCT00538473. The trial evaluated the safety and immunogenicity of the vaccine after repeated vaccination in elderly adults. It enrolled 68 participants in Belgium and used an active-controlled design.
Yes, GSK Biologicals' influenza vaccine GSK576389A and GSK Biologicals Influenza Vaccine GSK576389A refer to the same investigational vaccine developed by GSK plc. The two names are alternative spellings used interchangeably in trial records and other references.