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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00822757 | Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004) | PHASE1 | COMPLETED | 51 | — | — | Aug 1, 2007 | Dec 1, 2007 | Oct 2, 2015 | - | — |
Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | V710 |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Comparator: V710 | BIOLOGICAL | Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection. |
| Comparator: placebo | BIOLOGICAL | Single dose of buffered saline placebo (0.5 mL) by intramuscular injection. |
Inclusion Criteria: * 18 to 80 years of age * Good physical health based upon medical history and physical examination * Willing and able to participate in the entire study duration * Female subject with a negative urine pregnancy test immediately prior to study vaccination Exclusion Criteria: * ...