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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...
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 |
GSK investigational vaccine 2186877A is an influenza vaccine candidate developed by GSK plc. It is a Phase 3 investigational product studied for the prevention of influenza, and it has been evaluated in a completed Phase 3 trial in elderly volunteers. It is not described as an approved product.
GSK investigational vaccine 2186877A is being studied for use against influenza. Its clinical program evaluated the vaccine in elderly people, a population at higher risk from influenza. The only listed trial enrolled 370 participants and has been completed, so the candidate remains investigational rather than an approved influenza vaccine.
GSK investigational vaccine 2186877A is made and developed by GSK plc, which trades under the ticker GSK. GSK Biologicals, the company's vaccine unit, sponsored the Phase 3 study of this influenza vaccine candidate. No other developer or partner is named for this asset.
GSK investigational vaccine 2186877A has reached Phase 3. One Phase 3 trial has been completed, and no trials for this candidate are currently listed as active. Because the available record shows only completed clinical work, the vaccine is an investigational candidate and is not described as approved.
GSK investigational vaccine 2186877A was studied in the Phase 3 trial NCT00992784, titled a study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine in elderly people. That trial enrolled 370 participants across Germany, the Netherlands, and Sweden, was randomized, double blind, and active controlled, and is completed.
The Phase 3 trial NCT00992784 for GSK investigational vaccine 2186877A was a randomized, double blind, active controlled study in healthy volunteers aged 19 years and older, with both sexes eligible. It enrolled 370 participants in Germany, the Netherlands, and Sweden and assessed safety and immunogenicity in elderly people. The trial is completed.