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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01536405 | Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027) | PHASE3 | COMPLETED | 1,412 | — | — | Jun 5, 2012 | Jan 27, 2014 | Oct 31, 2018 | - | — |
Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Sera were tested for measles virus IgG antibody levels by an ELISA
Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
Sera were tested for rubella virus IgG antibody levels by an ELISA
Sera were tested for VZV IgG antibody levels by gpELISA
Sera were tested for measles virus IgG antibody levels by ELISA
Sera were tested for mumps virus IgG antibody levels by ELISA
Sera were tested for rubella virus IgG antibody levels by ELISA
| Arm | Type | Description |
|---|---|---|
| MMRV (AMP) | EXPERIMENTAL | Participants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP) |
| MMRV (2006 process) | ACTIVE_COMPARATOR | Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process |
| Name | Type | Description |
|---|---|---|
| MMRV (AMP) | BIOLOGICAL | Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections. |
| MMRV (2006 process) | BIOLOGICAL | Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections. |
Inclusion Criteria: * Negative clinical history for measles, mumps, rubella, varicella, and zoster Exclusion Criteria: * Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccine...