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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00968890 | Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly | PHASE2 | COMPLETED | 168 | — | — | Sep 12, 2009 | Sep 23, 2010 | Aug 20, 2018 | 2 | Sweden |
A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer \< 10 and a postvaccination reciprocal titer \>= 40, or a pre-vaccination reciprocal HI titer \>= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
A seroprotected subject was a subject with reciprocal HI titers \>= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
| Arm | Type | Description |
|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | EXPERIMENTAL | Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. |
| Pandemrix+Placebo and Pandemrix+Fluarix | EXPERIMENTAL | Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm. |
| Name | Type | Description |
|---|---|---|
| Pandemrix (Influenza vaccine GSK2340272A) | BIOLOGICAL | Intramuscular injection, 2 doses |
| Fluarix™ | BIOLOGICAL | Intramuscular injection, 1 dose |
| Placebo | BIOLOGICAL | Intramuscular injection, 1 dose |
Inclusion Criteria: * Male or female subjects 61 years of age or older at the time of the first vaccination * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Satisfactory baseline med...