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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00240877 | Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024) | PHASE3 | COMPLETED | 330 | — | — | Aug 1, 2002 | Apr 1, 2004 | Nov 20, 2008 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Monovalent vaccine prior to the release of the trivalent vaccine (FluMist). |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| AV024 | BIOLOGICAL | 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril). |
| Placebo | OTHER | Placebo mist consisting of normal allantoic fluid. 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril). |
Inclusion Criteria: * 18-64 years of age (not yet reached their 65th birthday); * In good health; * Available by telephone; * Ability to understand and comply with the requirements of the protocol; and * Signed informed consent. Exclusion Criteria: * Any condition, other than age, for which the i...