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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00979407 | Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1) | PHASE3 | COMPLETED | 336 | — | — | Oct 12, 2009 | Nov 4, 2010 | Aug 6, 2018 | 7 | France, Germany |
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.
| Arm | Type | Description |
|---|---|---|
| GSK2340272A GROUP | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| GSK2340274A GROUP | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| Name | Type | Description |
|---|---|---|
| Influenza vaccine GSK2340272A | BIOLOGICAL | Two intramuscular injections at Day 0 and Day 21 |
| Influenza vaccine GSK2340274A | BIOLOGICAL | Two intramuscular injections at Day 0 and Day 21 |
Inclusion Criteria: * Male or female aged 18 to 60 years inclusive, 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 medic...