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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00851266 | A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy Adults | PHASE1 | COMPLETED | 187 | — | — | Oct 1, 2006 | Jan 1, 2009 | Feb 12, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | V512 |
| 2 | PLACEBO_COMPARATOR | Placebo to V512 |
| Name | Type | Description |
|---|---|---|
| V512 | BIOLOGICAL | Subjects received 1 of 8 formulations of the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6: 1\) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 2) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 3) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 4) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 5) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX; 6) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 7) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 8) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX; |
| Comparator: Placebo to V512 | BIOLOGICAL | Subjects received placebo to the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6. |
Inclusion Criteria: * Subject is in good physical health * Subject is not in the category of individuals recommended by the CDC to receive influenza vaccine for the upcoming 2 influenza seasons * Subject agrees not to seek vaccination with licensed influenza vaccines during the study * Female subje...