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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00311441
First received: April 3, 2006
Last updated: March 14, 2008
Last verified: March 2008
  Purpose

The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.


Condition Intervention Phase
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.

Secondary Outcome Measures:
  • Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever

Estimated Enrollment: 300
Study Start Date: March 2005
  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311441

Locations
Germany
Weilheim, Germany
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Director: Drug Information Services Novartis Vaccines & Diagnostics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00311441     History of Changes
Other Study ID Numbers: M48P3, 911
Study First Received: April 3, 2006
Last Updated: March 14, 2008
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
TBE, children, vaccine

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 17, 2014