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Zoster Vaccine, Live,

Phase 3

Varicella Virus Infection | Monoclonal antibody | Other |Merck & Company, Inc.|Last Updated: Jun 4, 2015

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00444860ZOSTAVAX(R) Local Registration Trial (V211-019)PHASE3 COMPLETED 150Mar 1, 2007May 1, 2007Jun 4, 2015 -
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Study Endpoints
Primary Endpoints
The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed.
prevaccination and 4 weeks postvaccination
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTALZostavax
Interventions
NameTypeDescription
Zoster Vaccine, Live, (Oka-Merck)BIOLOGICALA single dose of 0.65 ml of Zostavax injection was given to each study subject
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent * All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test * Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Lev...

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