Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VARIVAX New Seed Process · 1 trial · 1 indication
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...
VARIVAX New Seed Process is an investigational varicella vaccine candidate developed by Merck & Company, Inc. (MRK). It is being evaluated for the prevention of varicella, commonly known as chickenpox, in children. The candidate uses a new seed process for manufacturing the vaccine and has been studied in a Phase 3 clinical trial.
VARIVAX New Seed Process is being developed for the prevention of varicella, also known as chickenpox, in children. The Phase 3 trial enrolled children from 12 months of age. It is an investigational vaccine candidate and is not described as approved for this use.
VARIVAX New Seed Process is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program evaluating this varicella vaccine candidate.
VARIVAX New Seed Process has been studied in a Phase 3 clinical trial. That trial, NCT02062502, is completed, and no active trials are listed. The candidate remains investigational and is not described as FDA approved.
VARIVAX New Seed Process was evaluated in the Phase 3 trial NCT02062502, titled Evaluation of Immunogenicity and Safety of VARIVAX New Seed Process (NSP) in Children (V210-063). The trial enrolled 611 children aged 12 months and older, was randomized, double blind, and active controlled, and is completed.
VARIVAX New Seed Process is also written as VARIVAX™ New Seed Process. It refers to a varicella vaccine candidate manufactured using a new seed process, evaluated in children for immunogenicity and safety in the Phase 3 trial NCT02062502.