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MMR, Varicella vacc

Phase 2

Varicella | Monoclonal antibody | Other |GSK plc|Last Updated: Oct 7, 2016

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment446
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00353288Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™PHASE2 COMPLETED 446Mar 1, 2006Nov 1, 2006Oct 7, 201639 France, Germany +1
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Study Endpoints
Primary Endpoints
Varicella seroconversion and MMR titres at 42-56 days after first vaccination
Secondary Endpoints
Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
MeMuRu-OKA (study vacc)BIOLOGICAL -
MMR, Varicella vacc (control)BIOLOGICAL -
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Eligibility Criteria
Age Range15 Months — 6 Years
SexALL
Healthy VolunteersYes
Study Sites39

Inclusion Criteria: * Children must be healthy to participate Exclusion Criteria: * Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excludi...

Countries:FranceGermanyItaly
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