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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00559975 | Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine | PHASE1 | COMPLETED | 60 | — | — | Oct 1, 2007 | May 1, 2008 | Nov 5, 2009 | 1 | Switzerland |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | - |
| 2 | ACTIVE_COMPARATOR | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Subunit influenza vaccine | BIOLOGICAL | 0.5 mL single dose vaccine |
| Adjuvanted influenza vaccine | BIOLOGICAL | 0.5 mL single dose vaccine |
| Adjuvanted influenza vaccine combined with CpG7909 | BIOLOGICAL | 0.5 ml influenza vaccine combined with 10 mcg of CpG7909 |
| Adjuvanted influenza vaccine combine with CpG7909 | BIOLOGICAL | 0.5 mL single dose vaccine combined with 30 mcg of CpG7909 |
Inclusion Criteria: * Healthy subjects aged 18 to ≤40 years Exclusion Criteria: * Any serious disease, hypersensitivity to egg or vaccine components, neurological symptoms or positive antibody test against dsDNA, RF, ANA or thyroid. * Abnormal TSH from blood samples collected during the screening...