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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00092417 | Evaluation of the Safety and Tolerability of a Higher Potency Dose of an Investigational Vaccine Among Adults 50 Years of Age and Older (V211-009) | PHASE3 | COMPLETED | 695 | — | — | Oct 1, 2003 | Jun 1, 2004 | Oct 7, 2015 | - | — |
The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Higher Potency Dose |
| 2 | EXPERIMENTAL | Lower Potency Dose |
| Name | Type | Description |
|---|---|---|
| Comparator: Varicella Zoster Virus Vaccine | BIOLOGICAL | Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (\~207,000 plaque-forming units \[PFU\]/0.65-mL dose) |
Inclusion Criteria: * Healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster Exclusion Criteria : * Preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response