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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01018641 | An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults | PHASE1 | COMPLETED | 449 | — | — | Jan 1, 2010 | Jul 1, 2011 | Apr 24, 2014 | 5 | Australia |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | SA3Ag in both stage 1 and stage 2 |
| 2 | EXPERIMENTAL | SA3Ag in stage 1 followed by placebo in stage 2. |
| 3 | PLACEBO_COMPARATOR | Placebo in both stage 1 and stage 2 |
| 4 | EXPERIMENTAL | SA3Ag in stage 1 and no vaccine in stage 2. |
| 5 | PLACEBO_COMPARATOR | Placebo in stage 1 and no vaccine in stage 2. |
| Name | Type | Description |
|---|---|---|
| SA3Ag vaccine | BIOLOGICAL | In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses: Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm In stage 2 the subject will receive 0.5 mL IM of the same dose level he/she received in stage 1. |
| Blood draw | PROCEDURE | Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1. |
| Colonization swab samples | PROCEDURE | Colonization swabs will be taken at timepoints throughout stage 1 and stage 2. |
| SA3Ag followed by Placebo | BIOLOGICAL | In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses: Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm In stage 2 the subject will receive one injection of 0.5 mL IM of the placebo. |
| Placebo | BIOLOGICAL | In both stage 1 and stage 2, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl for a total of 2 injections throughout the study. |
| SA3Ag with no booster in stage 2 | BIOLOGICAL | In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses: Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm In stage 2 the subject will receive no vaccine. |
| Placebo with no booster in stage 2 | PROCEDURE | In stage 1, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl. In stage 2 the subject will receive no vaccine. |
Inclusion Criteria: * Healthy adults aged 18 to 24 years or 50 to 85 years who are available for the entire duration of the study, able to be contacted by phone, and able to complete all study procedures, including completion of an electronic diary (e-diary). * Men and women who are able to have ch...