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ML Risk
GSK investigational vaccine 2186877A · 1 trial · 1 indication
Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.
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-≤ 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade, grade 3 was defined as general symptom that prevented normal activity and related was general symptom 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 unsolicited symptom that prevented normal activity and related was 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 symptom that prevented normal activity and related was 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, grade 3 was defined as symptom that prevented normal activity and related was general symptom 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 was defined as occurrence of any symptom regardless of intensity grade and related was event 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 was defined as occurrence of any symptom regardless of intensity grade and related was 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 receiving 1 dose of New generation influenza vaccine GSK2186877A |
| Fluarix elderly Group | ACTIVE_COMPARATOR | Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine |
| Fluarix young Group | ACTIVE_COMPARATOR | Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine |
| Name | Type | Description |
|---|---|---|
| GSK investigational vaccine 2186877A | BIOLOGICAL | Single dose, intramuscular injection |
| FluarixTM | BIOLOGICAL | Single dose, intramuscular injection |
Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of s...
GSK investigational vaccine 2186877A is used for influenza, an infectious disease. It is being developed as a vaccine to prevent influenza, with a completed Phase 3 trial evaluating its safety and immunogenicity in elderly people. The vaccine is still investigational and has not been approved.
GSK investigational vaccine 2186877A is developed by GSK plc, a biopharma company listed on the stock exchange under the ticker GSK. The company conducted a Phase 3 clinical trial to evaluate the vaccine's safety and immunogenicity in elderly participants.
GSK investigational vaccine 2186877A is in Phase 3 clinical development. A Phase 3 trial, NCT00992784, has been completed, evaluating the vaccine in 370 elderly participants. The vaccine remains investigational and is not yet approved for use.
GSK investigational vaccine 2186877A has one completed Phase 3 clinical trial, NCT00992784, titled 'Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People'. The trial enrolled 370 participants in Germany, Netherlands, and Sweden, and was randomized, double-blind, and active-controlled.
Yes, GSK investigational vaccine 2186877A is a monoclonal antibody, despite being referred to as a vaccine. It is being developed for influenza and has undergone a Phase 3 trial. The trial focused on safety and immunogenicity in elderly people, with 370 participants enrolled.