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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02062502 | Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063) | PHASE3 | COMPLETED | 611 | — | — | Mar 7, 2014 | Oct 13, 2015 | Oct 30, 2018 | - | — |
Antibody titers were measured with gpELISA.
| Arm | Type | Description |
|---|---|---|
| VARIVAX™ NSP + M-M-R II™ | EXPERIMENTAL | VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91 |
| VARIVAX™ 2007 Process + M-M-R II™ | ACTIVE_COMPARATOR | VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91 |
| Name | Type | Description |
|---|---|---|
| VARIVAX™ New Seed Process | BIOLOGICAL | Varicella virus vaccine live manufactured with a new seed process |
| VARIVAX™ 2007 process | BIOLOGICAL | Varicella virus vaccine live manufactured with the 2007 process |
| M-M-R II™ | BIOLOGICAL | Measles, Mumps, and Rubella virus vaccine live |
Inclusion Criteria: * Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella Exclusion Criteria: * Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study * Any con...