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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
  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
Intervention Model: Parallel Assignment
Masking: Single
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311441


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

ClinicalTrials.gov Identifier: NCT00311441     History of Changes
Other Study ID Numbers: M48P3
911
First Submitted: April 3, 2006
First Posted: April 6, 2006
Last Update Posted: March 17, 2008
Last Verified: March 2008

Keywords provided by Novartis:
TBE, children, vaccine

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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