Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Bio's influenza vaccine GSK2186877A · 2 trials · 1 indication
Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.
Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (\>) 20mm.
Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature \>40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a 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 adverse event (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 possibly 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 possibly 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 possibly 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 autoiimune 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 possibly 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.
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.
Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects.
| Arm | Type | Description |
|---|---|---|
| New generation influenza vaccine GSK2186877A Group | EXPERIMENTAL | Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A |
| Fluarix elderly Group | ACTIVE_COMPARATOR | Subjects aged ≥65 years received 1 dose of Fluarix vaccine |
| Fluarix young Group | ACTIVE_COMPARATOR | Subjects aged 18-40 years received 1 dose of Fluarix vaccine |
| FluNG Group | EXPERIMENTAL | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Fluarix Group | ACTIVE_COMPARATOR | subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Name | Type | Description |
|---|---|---|
| GSK Bio's influenza vaccine GSK2186877A | BIOLOGICAL | Intramuscular (IM) administration, 1 dose |
| Fluarix | BIOLOGICAL | Intramuscular (IM) administration, 1 dose |
| Fluarix TM | BIOLOGICAL | IM administration, two times one annual dose |
Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * A male or female aged 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up. * Written i...
GSK2186877A is an investigational influenza vaccine developed by GSK plc for the prevention of influenza. It is being studied in adults, including those 65 years of age and older, to evaluate its efficacy, safety, and immunogenicity against the flu.
GSK2186877A is developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is part of GSK's infectious disease portfolio and is currently in Phase 3 clinical development for influenza.
GSK2186877A is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, but the vaccine remains under investigation for the prevention of influenza.
GSK2186877A has been evaluated in two completed Phase 3 trials. NCT00753272 assessed efficacy in adults 65 years and older with 43,695 participants, and NCT00760617 evaluated safety and immunogenicity in adults 18 years and older with 526 participants. Both trials were randomized, double-blind, and active-controlled.
GSK2186877A is a monoclonal antibody-based influenza vaccine. It is designed to stimulate the immune system to produce a protective response against influenza viruses, helping to prevent infection. The vaccine targets the influenza virus to reduce the risk of flu illness.
GSK2186877A is a distinct investigational vaccine developed by GSK. It is not identified as being the same as any other marketed influenza vaccine. Its specific formulation and antigen composition are part of GSK's proprietary development program for influenza prevention.