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Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

Tick-borne Encephalitis Clinical Trial

Official title:
Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

Clinical Trial Summary

The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00161863
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 3
Start date September 2002
Completion date January 2003
View Details
See also
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