Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VARIVAX PE34 Process · 1 trial · 1 indication
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...
VARIVAX PE34 Process is an investigational varicella vaccine candidate developed by Merck & Company, Inc. (MRK). It is a monoclonal antibody evaluated for varicella, also known as chickenpox. The PE34 designation refers to a specific passage extension process used in its manufacture.
VARIVAX PE34 Process is being evaluated for the prevention of varicella, commonly known as chickenpox. The Phase 3 trial enrolled healthy children 12 months of age and older in the United States. It is not yet approved for use.
VARIVAX PE34 Process is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. Merck is the sponsor of the clinical program evaluating this varicella vaccine candidate.
VARIVAX PE34 Process has completed a Phase 3 clinical trial. It is an investigational product and has not been approved by the FDA. The trial, NCT03239873, was a randomized, double-blind, active-controlled study that enrolled 600 participants.
VARIVAX PE34 Process was evaluated in one completed Phase 3 trial, NCT03239873, titled Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03). The trial enrolled 600 healthy children aged 12 months and older in the United States.
VARIVAX PE34 Process is also known as VARIVAX® PE34 Process. It refers to a specific passage extension 34 manufacturing process for VARIVAX, evaluated in a Phase 3 trial to assess immunogenicity and safety in children.