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VARIVAX New Seed Process

Phase 3

Varicella | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Last Updated: Oct 30, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment611

FDA Designations

No designations recorded

Clinical trial landscape

VARIVAX New Seed Process · 1 trial · 1 indication

Phase 3 1
NCT02062502Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)Varicella
COMPLETED611 Analytics
PHASE3COMPLETED
Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
Varicella
NCT02062502611
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Study Endpoints

Primary Endpoints

Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
6 weeks (43 days) after vaccination 1
Geometric Mean Titer of VZV Antibodies
6 weeks (43 days) after vaccination 1

Antibody titers were measured with gpELISA.

Secondary Endpoints

Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)
Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
Up to 42 days after Vaccination 1
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
Up to 42 days after Vaccination 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VARIVAX™ NSP + M-M-R II™EXPERIMENTALVARIVAX™ 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_COMPARATORVARIVAX™ 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

Interventions

NameTypeDescription
VARIVAX™ New Seed ProcessBIOLOGICALVaricella virus vaccine live manufactured with a new seed process
VARIVAX™ 2007 processBIOLOGICALVaricella virus vaccine live manufactured with the 2007 process
M-M-R II™BIOLOGICALMeasles, Mumps, and Rubella virus vaccine live
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Eligibility Criteria

Age Range12 Months to 23 Months
SexALL
Healthy VolunteersYes

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...

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Frequently asked questions about VARIVAX New Seed Process

What is VARIVAX New Seed Process used for?

VARIVAX New Seed Process is a varicella vaccine used to prevent chickenpox in children. It is being studied for the prevention of varicella, the disease caused by the varicella-zoster virus. The vaccine is intended for use in pediatric populations, with clinical trials enrolling children as young as 12 months of age.

Who makes VARIVAX New Seed Process?

VARIVAX New Seed Process is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical development of this varicella vaccine candidate to evaluate its immunogenicity and safety in children.

What phase is VARIVAX New Seed Process in?

VARIVAX New Seed Process is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine remains under evaluation for the prevention of varicella in children.

What clinical trials is VARIVAX New Seed Process in?

VARIVAX New Seed Process has one completed Phase 3 clinical trial, identified as NCT02062502. The trial, titled 'Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063),' enrolled 611 participants. The study was randomized, double-blind, and active-controlled, evaluating the vaccine in children aged 12 months and older.

Is VARIVAX New Seed Process the same as VARIVAX?

VARIVAX New Seed Process is a version of the varicella vaccine produced by Merck. The 'New Seed Process' refers to a manufacturing process change for the vaccine. The clinical trial evaluates the immunogenicity and safety of this new seed process version in children, comparing it to an active control.