Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Varicella Virus Vaccine Live (Oka-Merck)
Varicella Virus Vaccine Live · 2 trials · 1 indication
Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer \< 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only.
| Arm | Type | Description |
|---|---|---|
| VARIVAX 2007 process + M-M-R II | EXPERIMENTAL | - |
| VARIVAX 1999 process + M-M-R II | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | Open label |
| Name | Type | Description |
|---|---|---|
| Varicella Virus Vaccine Live (2007 Process) (Oka/Merck) | BIOLOGICAL | VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart |
| Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck) | BIOLOGICAL | VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart |
| Measles, Mumps, and Rubella Virus Vaccine Live (MMR) | BIOLOGICAL | M-M-R II in two 0.5 mL doses by injection \~6 weeks apart |
| Varicella Virus Vaccine Live (Oka-Merck) | BIOLOGICAL | VARIVAX(TM) (Refrigerated) \[Varicella Virus Vaccine Live (Oka/Merck), Refrigerator-Stable Formulation.\] Subjects enrolled in the study received one 0.5 mL subcutaneous dose of VARIVAX(TM). Frequency is single dose. |
Inclusion Criteria: * Subject is in good health based on medical history * Subject has no history of measles, mumps, rubella, chickenpox, or shingles Exclusion Criteria: * Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination * Subject ha...
Varicella Virus Vaccine Live is used to prevent varicella, commonly known as chickenpox. It is a vaccine developed by Merck & Company, Inc. (ticker MRK) for use in the infectious disease therapeutic area. The vaccine is designed to protect against the varicella virus.
Varicella Virus Vaccine Live is made by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the developer of this vaccine, which is intended for the prevention of varicella.
Varicella Virus Vaccine Live is in Phase 3 clinical development. It is an investigational vaccine and has been studied in two completed Phase 3 trials. It is not stated to be FDA approved.
Varicella Virus Vaccine Live has been studied in two completed Phase 3 trials: NCT00822237, which enrolled 598 participants, and NCT00496327, which enrolled 100 participants. Both trials evaluated the safety and immunogenicity of the vaccine in healthy volunteers.