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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00617851 | Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old | PHASE3 | COMPLETED | 1,507 | — | — | Nov 1, 2007 | Jun 1, 2008 | May 8, 2012 | 2 | Dominican Republic |
The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.
| Arm | Type | Description |
|---|---|---|
| Influenza virus vaccine (lot A) | EXPERIMENTAL | Lot A of the investigational influenza virus vaccine |
| Influenza virus vaccine (lot B) | EXPERIMENTAL | Lot B of the investigational influenza virus vaccine |
| Influenza virus vaccine (lot C) | EXPERIMENTAL | Lot C of the investigational influenza virus vaccine |
| Influenza virus vaccine (pooled) | EXPERIMENTAL | Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine |
| Comparator influenza vaccine | ACTIVE_COMPARATOR | A US licensed influenza virus vaccine |
| Name | Type | Description |
|---|---|---|
| Lot A of Influenza virus vaccine | BIOLOGICAL | 1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly |
| Lot B of Influenza virus vaccine | BIOLOGICAL | 1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly |
| Lot C of Influenza virus vaccine | BIOLOGICAL | 1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly |
| Comparator influenza virus vaccine | BIOLOGICAL | 1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly |
| All 3 consecutive lots of influenza virus vaccine pooled | BIOLOGICAL | 1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly |
Inclusion Criteria: * 18 to 49 years of age; * In good health as determined by medical history and physical examination; * Able and willing to provide written informed consent prior to any study procedure; * Able to comply with all study procedures and available for all clinic visits scheduled in t...