Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00363077 | Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate | PHASE2 | COMPLETED | 150 | — | — | Oct 2, 2006 | Nov 17, 2006 | Jun 8, 2018 | 1 | Belgium |
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...