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 a varicella vaccine used for the prevention of varicella, commonly known as chickenpox. It is being developed by Merck & Company, Inc. for use in children. The vaccine is currently in Phase 3 clinical development and is considered investigational.
VARIVAX PE34 Process is a monoclonal antibody, but its specific molecular target is not disclosed in the available information. It is being studied for its immunogenicity and safety in preventing varicella, the disease caused by the varicella-zoster virus.
VARIVAX PE34 Process is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in children.
VARIVAX PE34 Process is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 600 participants, to assess its immunogenicity and safety.
VARIVAX PE34 Process has one completed Phase 3 clinical trial, identified as NCT03239873, titled 'Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)'. This randomized, double-blind, active-controlled study enrolled 600 healthy children aged 12 months and older in the United States.
VARIVAX PE34 Process is a version of the VARIVAX vaccine, which is Merck's varicella vaccine. The PE34 designation refers to a specific manufacturing process, Passage Extension 34, being evaluated in clinical trials. It is not a different vaccine but a process change being studied for immunogenicity and safety.