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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014