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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00989612 | Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) | PHASE2 | COMPLETED | 100 | — | — | Oct 1, 2009 | Apr 19, 2010 | Jan 16, 2019 | 2 | Japan |
Titers are presented as geometric mean titers (GMTs).
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
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.
| Arm | Type | Description |
|---|---|---|
| GSK2340274A GROUP | EXPERIMENTAL | Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected 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 investigational vaccine GSK2340274A | BIOLOGICAL | Two intramuscular injections on Day 0 and Day 21, respectively |
Inclusion Criteria: * Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive. * Good general health as assessed by medical history and physical examination * Subjects who the investigator believes that they can and will comply with the requirements of the ...