Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Influenza Vaccine GSK1247446A- 4 different formulations · 1 trial · 1 indication
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
| Arm | Type | Description |
|---|---|---|
| GSK1247446A 1 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 2 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 3 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 4 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix Group | ACTIVE_COMPARATOR | Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Influenza Vaccine GSK1247446A - 4 different formulations | BIOLOGICAL | Single dose, Intramuscular injection |
| Fluarix™ | BIOLOGICAL | Single dose, Intramuscular injection |
Inclusion Criteria: * Only subjects who the investigator believes that they can and will comply with the requirements of the protocol . * A male or female between, and including, 18 - 64 years of age at the time of vaccination. * Written informed consent obtained from the subject. * Healthy subject...
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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 |
| 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 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
Influenza Vaccine GSK1247446A is an investigational vaccine developed by GSK plc for the prevention of influenza. It is being studied in four different formulations. The vaccine is intended for adults 18 years and older and is designed to protect against influenza virus infection.
Influenza Vaccine GSK1247446A is being developed by GSK plc, which trades under the ticker GSK. GSK is a global pharmaceutical company. The vaccine candidate is part of GSK's influenza vaccine research program.
Influenza Vaccine GSK1247446A is in Phase 2 clinical development. A Phase 2 trial has been completed. The vaccine is investigational and has not been approved by the FDA or any regulatory authority for any indication.
Influenza Vaccine GSK1247446A has been evaluated in one completed Phase 2 clinical trial, NCT00540228, titled "Study to Evaluate an Influenza Vaccine Candidate." The trial enrolled 1,006 participants across France, Germany, and Spain. It was randomized, active-controlled, and included healthy volunteers aged 18 years and older.
Yes, Influenza Vaccine GSK1247446A is also known as Influenza Vaccine GSK1247446A - 4 different formulations. The longer name reflects that the candidate includes four different formulations. Both names refer to the same investigational influenza vaccine developed by GSK plc.