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FSME-IMMUN NEW

Phase 3

Tick-borne Encephalitis | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: May 21, 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 Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00161863Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 YearsPHASE3 COMPLETED -Sep 1, 2002Jan 1, 2003May 21, 20158 Austria, Germany +1
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Interventions
NameTypeDescription
FSME-IMMUN NEW 0.25 mlBIOLOGICAL -
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Eligibility Criteria
Age Range1 Year — 15 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: Male and female children and adolescents will be eligible for participation in this study if: * they are aged 1 year (from the 1st birthday) to \< 16 years (to the last day before the 16th birthday); * they are clinically healthy, (i. e. the physician would have no reservations...

Countries:AustriaGermanyPoland
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