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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03239873 | Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03) | PHASE3 | COMPLETED | 600 | — | — | Oct 17, 2017 | Apr 2, 2019 | Jan 27, 2021 | 37 | United States |
The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers \<1.25 gpELISA units/mL) at baseline.
The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.
| Arm | Type | Description |
|---|---|---|
| VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II® | EXPERIMENTAL | VARIVAX® Passage Extension (PE34) Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91 |
| VARIVAX® 2016 Commercial Process + M-M-R II® | ACTIVE_COMPARATOR | VARIVAX® 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91 |
| Name | Type | Description |
|---|---|---|
| VARIVAX® PE34 Process | BIOLOGICAL | Varicella virus vaccine live manufactured with a new passage extension process (PE34) |
| VARIVAX® 2016 Commercial Process | BIOLOGICAL | Varicella virus vaccine live manufactured with the 2016 commercial 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...