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MMRV

Phase 3

Rubella | Monoclonal antibody | Other |GSK plc|Last Updated: Sep 15, 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 Enrollment398
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00406211Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined VaccinePHASE3 COMPLETED 398Jul 1, 2004Dec 1, 2004Sep 15, 201641 Austria, Germany
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Study Endpoints
Primary Endpoints
Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
MMRVBIOLOGICAL -
MMR (Priorix®)BIOLOGICAL -
Varicella (Varilrix®)BIOLOGICAL -
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Eligibility Criteria
Age Range12 Months — 18 Months
SexALL
Healthy VolunteersYes
Study Sites41

Inclusion Criteria: * Written informed consent from the parents/guardians of the child before participating in the long-term follow-up. * Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combin...

Countries:AustriaGermany
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