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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00812981 | A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine. | PHASE3 | COMPLETED | 320 | — | — | Nov 15, 2008 | Jun 7, 2009 | Aug 20, 2018 | 1 | Taiwan |
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
| Arm | Type | Description |
|---|---|---|
| 1562902A NP GROUP | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21. |
| 1562902A CP GROUP | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21. |
| Name | Type | Description |
|---|---|---|
| GSK1562902A | BIOLOGICAL | new-processed (NP), administered intramuscularly in the deltoid region of the non-dominant arm |
Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female aged 18 to 60 years at the time of the first vaccination. * Written informed consent obtained from the subject. * Good...