Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Influenza vaccine GSK2186877A formulation 1, Influenza vaccine GSK2186877A formulation 2
Influenza vaccine GSK2186877A · 2 trials · 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.
Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature \>38 degree centigrade (°C).
| 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. |
| Influenza vaccine GSK2186877A formulation 1 Group | EXPERIMENTAL | Subjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6. |
| Influenza vaccine GSK2186877A formulation 2 Group | EXPERIMENTAL | Subjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6. |
| Name | Type | Description |
|---|---|---|
| Influenza vaccine GSK2186877A | BIOLOGICAL | One intramuscularly injection at Day 0 |
| GSK Biologicals' Fluarix™ | BIOLOGICAL | One intramuscularly injection at Day 0 |
| Influenza vaccine GSK2186877A formulation 1 | BIOLOGICAL | Intramuscular administration, 2 doses |
| Influenza vaccine GSK2186877A formulation 2 | BIOLOGICAL | Intramuscular administration, 1 dose |
| Fluarix | BIOLOGICAL | Intramuscular administration, 1 dose |
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...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
Influenza vaccine GSK2186877A is an investigational vaccine developed by GSK plc for the prevention of influenza. It is a Phase 3 candidate that has been studied in both healthy children and elderly adults. The vaccine is designed to stimulate an immune response against influenza virus.
Influenza vaccine GSK2186877A is being developed for the prevention of influenza. Clinical trials have evaluated its safety and immunogenicity in healthy children and in elderly adults. It is intended to protect against influenza infection.
Influenza vaccine GSK2186877A is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the sponsor of the clinical trials evaluating this influenza vaccine candidate.
Influenza vaccine GSK2186877A is in Phase 3 clinical development. A Phase 3 trial has been completed in elderly adults, and a Phase 1 trial has been completed in healthy children. The vaccine remains investigational and has not been approved by the FDA.
Influenza vaccine GSK2186877A has been evaluated in two completed clinical trials. NCT00772889 was a Phase 3 trial in elderly adults across the United States, Belgium, Germany, and Norway. NCT01096056 was a Phase 1 trial in healthy children in Spain.
Yes, Influenza vaccine GSK2186877A formulation 1 and Influenza vaccine GSK2186877A formulation 2 are alternative names for the same vaccine candidate. All refer to the investigational influenza vaccine developed by GSK plc.