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FSME-IMMUN NEW

Phase 3

Tick-borne Encephalitis | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Trials Updated: May 21, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

FSME-IMMUN NEW clinical trials

FSME-IMMUN NEW · 1 trial · 1 indication

Phase 3 1
NCT00161863Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 YearsTick-borne Encephalitis
COMPLETED- Analytics
PHASE3COMPLETED
Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
Tick-borne EncephalitisUnlock trial analytics

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 to 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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Frequently asked questions about FSME-IMMUN NEW

What is FSME-IMMUN NEW used for?

FSME-IMMUN NEW is being developed for the prevention of tick-borne encephalitis, a viral infection of the central nervous system transmitted by tick bites. It is intended for use in healthy children and adolescents aged 1 to 15 years. The program is in Phase 3 clinical development.

Who makes FSME-IMMUN NEW?

FSME-IMMUN NEW is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor responsible for the clinical development program for this tick-borne encephalitis candidate.

What phase is FSME-IMMUN NEW in?

FSME-IMMUN NEW is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The program includes one completed Phase 3 trial, with no active trials currently listed.

What clinical trials is FSME-IMMUN NEW in?

FSME-IMMUN NEW has been studied in one Phase 3 trial, NCT00161863, titled Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years. The trial is completed and enrolled participants in Austria, Germany, and Poland.

What is FSME-IMMUN NEW?

FSME-IMMUN NEW is an investigational monoclonal antibody developed by Pfizer, Inc. for tick-borne encephalitis. It is in Phase 3 development and has been evaluated in healthy children and adolescents aged 1 to 15 years in a completed safety study.