A Phase IV, Randomized, Controlled, Single-Blind, Multi-Center Study in Children to Evaluate the Safety, Tolerability and Immunogenicity of Two TBE Vaccines Administered According to Two Different Schedules.
Sponsor study identifier
Secondary identifiers
interventional
300
1 country
1
Study Start
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedThe purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
April 3, 2006
Actual (reported)April 6, 2006
Actual (reported)Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.
Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Weilheim, Germany
Drug Information Services
Novartis Vaccines & Diagnostics
First Submitted
April 3, 2006
First Posted
April 6, 2006
Study Start
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
March 17, 2008
Record last verified: 2008-03
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Source: ClinicalTrials.gov.
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