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Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311441
First Posted: April 6, 2006
Last Update Posted: March 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
April 3, 2006
April 6, 2006
March 17, 2008
March 2005
Not Provided
Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.
Not Provided
Complete list of historical versions of study NCT00311441 on ClinicalTrials.gov Archive Site
Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever
Not Provided
Not Provided
Not Provided
 
Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children
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.
The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
Not Provided
Not Provided

Inclusion Criteria:

  • Healthy male and female children, 1 to 10 years of age.

Exclusion Criteria:

  • Subjects with documented evidence of TBE
  • Subjects, who have been previously vaccinated against TBE
Sexes Eligible for Study: All
1 Year to 10 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00311441
M48P3
911
Not Provided
Not Provided
Not Provided
Not Provided
Novartis
Novartis Vaccines
Study Director: Drug Information Services Novartis Vaccines & Diagnostics
Novartis
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP