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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00985166 | A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014) | PHASE3 | COMPLETED | 801 | — | — | Aug 1, 2000 | May 1, 2003 | Jul 28, 2015 | - | — |
| NCT00986232 | ProQuad Dose Selection Study (V221-011)(COMPLETED) | PHASE2 | COMPLETED | 1,551 | — | — | Apr 1, 1999 | Sep 1, 2000 | Apr 10, 2015 | - | — |
Postvaccination observed Geometric Mean Titer of antibody to Varicella
Postvaccination observed Geometric Mean Titer of antibody to Measles
Postvaccination observed Geometric Mean Titer of antibody to Mumps
Postvaccination observed Geometric Mean Titer of antibody to Rubella
Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer \<1.25 gpELISA units
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | ProQuad + Placebo |
| 2 | ACTIVE_COMPARATOR | M-M-R II + Placebo |
| 3 | ACTIVE_COMPARATOR | M-M-R II + Varivax |
| 4 | ACTIVE_COMPARATOR | M-M-R II + PUVV |
| Name | Type | Description |
|---|---|---|
| ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live) | BIOLOGICAL | A Single 0.5 mL subcutaneous injection at Day 1 |
| Comparator: M-M-R II | BIOLOGICAL | A Single 0.5 mL subcutaneous injection at Day 1 |
| Comparator: Varivax | BIOLOGICAL | A Single 0.5 mL subcutaneous injection at Day 1 |
| Comparator: Placebo | BIOLOGICAL | A Single 0.5 mL subcutaneous placebo injection at Day 1 |
| Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live | BIOLOGICAL | a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90 |
| Comparator: PUVV | BIOLOGICAL | A single 0.5 mL subcutaneous injection at Day 0 |
Inclusion Criteria: * In good health * Received primary dose of M-M-R II at less than or equal to 12 months of age * Received primary dose of Varivax at less than or equal to 12 months of age * Negative history of varicella, zoster, measles, mumps, and rubella Exclusion Criteria: * history of rec...