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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00985153 | Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED) | PHASE3 | COMPLETED | 3,927 | — | — | Mar 1, 2000 | May 1, 2001 | Nov 23, 2015 | - | — |
| NCT00975507 | ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED) | PHASE3 | COMPLETED | 480 | — | — | Mar 1, 1998 | Jun 1, 1999 | Oct 6, 2015 | - | — |
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \< 1.25 gpELISA units/mL at Baseline
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 120 mIU/mL) to Measles at Baseline
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 10 Ab units/mL) to Mumps at Baseline
Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 10 IU/mL) to Rubella at Baseline
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
Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of \<0.6 gpELISA units/mL) to Varicella at Baseline
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | ProQuad Lot 1 |
| 2 | EXPERIMENTAL | ProQuad Lot 2 |
| 3 | EXPERIMENTAL | ProQuad Lot 3 |
| 4 | ACTIVE_COMPARATOR | M-M-R II + Varivax |
| Name | Type | Description |
|---|---|---|
| Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live | BIOLOGICAL | A Single 0.5 mL subcutaneous injection at Day 0 |
| Comparator: Varivax | BIOLOGICAL | A Single 0.5 mL subcutaneous injection at Day 0 |
| Comparator: M-M-R II | BIOLOGICAL | A Single 0.5 mL subcutaneous injection at Day 0 |
| Comparator: Placebo | BIOLOGICAL | a single 0.5 mL subcutaneous placebo injection at Day 0 |
Inclusion Criteria: * In good health * Negative clinical history of measles, mumps, rubella, varicella, and zoster Exclusion Criteria: * Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination * Any immune impairment or deficiency * Exposure to measles,...