Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
GSK1247446A Group is an investigational monoclonal antibody being studied for use in influenza. It is currently in Phase 2 clinical development as a potential treatment or preventive option for the disease. The drug is being developed by GSK plc.
GSK1247446A Group is developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the drug's safety and immunogenicity in the context of influenza.
GSK1247446A Group is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its potential use in influenza, with clinical trials ongoing to assess its effects.
GSK1247446A Group has been evaluated in a Phase 2 clinical trial with the identifier NCT00363077. This completed study, titled 'Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate,' enrolled 150 participants aged 60 years and older in Belgium.
Yes, GSK1247446A Group is a monoclonal antibody. It is being developed as an investigational therapy for influenza, with a focus on evaluating its immunogenicity and safety profile in clinical studies. The drug is currently in Phase 2 development by GSK plc.