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Varicella Virus Vaccine Live

Phase 3

Varicella | Monoclonal antibody | Other |Merck & Company, Inc.|Last Updated: Jan 18, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00496327Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children (V210-056)PHASE3 COMPLETED 100Jun 22, 2005Oct 6, 2005Jan 18, 2019 -
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Study Endpoints
Primary Endpoints
Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination
6 weeks post-vaccination
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTALOpen label
Interventions
NameTypeDescription
Varicella Virus Vaccine Live (Oka-Merck)BIOLOGICALVARIVAX(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.
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Eligibility Criteria
Age Range12 Years — 12 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy Children, Between 12 Months And 12 Years Of Age * Parent Or Legal Guardian Should Be Willing And Able To Sign The Informed Consent Form Prior To Entry Into The Study Exclusion Criteria: * Any Immune Impairment Or Deficiency, Neoplastic Disease, Or Depressed Immunity,...

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