Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK1247446A, Low dose adjuvanted influenza vaccine
GSK1247446A Group · 1 trial · 1 indication
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
| Arm | Type | Description |
|---|---|---|
| GSK1247446A Group | EXPERIMENTAL | Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Fluarix Group | ACTIVE_COMPARATOR | Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| GSK1247446A Group | BIOLOGICAL | Low dose influenza vaccine adjuvanted with AS03 compared |
| Fluarix™ | BIOLOGICAL | GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine. |
Inclusion Criteria: * Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study. * A male or female 60 years or older at the time of the first vaccination. * Free of obvious health problems Exclusion Criteria: * Use o...
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| 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 |
GSK1247446A Group is being studied for influenza, the viral respiratory infection. It is an investigational monoclonal antibody developed by GSK plc. The program has been evaluated in a Phase 2 trial in older adults, a population at higher risk of influenza complications.
GSK1247446A Group is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor of the clinical program evaluating this monoclonal antibody candidate in influenza.
GSK1247446A Group is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The candidate is investigational and has not been approved for any indication.
GSK1247446A Group has been evaluated in one completed Phase 2 trial, NCT00363077, titled a study to evaluate the immunogenicity and safety of an adjuvanted influenza vaccine candidate. The trial enrolled 150 participants aged 60 years and older in Belgium and was active-controlled and randomized.
Yes, GSK1247446A and GSK1247446A Group refer to the same investigational monoclonal antibody for influenza. GSK1247446A is the alternative name used for this GSK plc development program.