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

NCT00161863 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-05-21

No results posted yet for this study

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.

Conditions

  • Tick-borne Encephalitis

Interventions

BIOLOGICAL

FSME-IMMUN NEW 0.25 ml

Sponsors & Collaborators

Principal Investigators

  • Baxter BioScience Investigator · Baxter BioScience

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Completion
2003-01-31

Countries

  • Austria
  • Germany
  • Poland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00161863 on ClinicalTrials.gov