Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Influenza vaccine GSK2186877A · 1 trial · 1 indication
Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was \>20 mm for ecchymosis, redness and swelling.
Duration was defined as number of days with any grade of local symptoms.
Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.
Duration was defined as number of days with any grade of general symptoms.
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 was defined as occurrence of any unsolicited symptom regardless of intensity grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.
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 was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.
| Arm | Type | Description |
|---|---|---|
| New generation influenza vaccine GSK2186877A Group | EXPERIMENTAL | Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A. |
| Fluarix elderly Group | ACTIVE_COMPARATOR | Subjects aged ≥66 years received one dose of Fluarix vaccine. |
| Fluarix young Group | ACTIVE_COMPARATOR | Subjects aged 19-43 years received one dose of Fluarix vaccine. |
| Name | Type | Description |
|---|---|---|
| Influenza vaccine GSK2186877A | BIOLOGICAL | One intramuscularly injection at Day 0 |
| GSK Biologicals' Fluarix™ | BIOLOGICAL | One intramuscularly injection at Day 0 |
Inclusion Criteria: * A male or female subject previously enrolled in study 109821 (NCT 00529516) in the \>= 65 years and 18-41 years of age groups and having received the study vaccine. * Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol...
Influenza vaccine GSK2186877A is an investigational vaccine being developed for the prevention of influenza. It is currently in Phase 3 clinical development and has been evaluated in a completed clinical trial involving 971 participants.
Influenza vaccine GSK2186877A is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK.
Influenza vaccine GSK2186877A is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
Influenza vaccine GSK2186877A has one completed Phase 3 clinical trial, NCT00772889, titled 'Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly.' The trial enrolled 971 participants and was conducted in the United States, Belgium, Germany, and Norway.
Influenza vaccine GSK2186877A is classified as a monoclonal antibody modality, though it is being developed as a vaccine for influenza. It is currently in Phase 3 clinical development.