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

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ClinicalTrials.gov Identifier: NCT00311441
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : March 17, 2008
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis

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

Condition or disease Intervention/treatment Phase
Encephalitis, Tick-Borne Biological: Tick-Borne Encephalitis vaccine Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
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.
Study Start Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources




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

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


Information from the National Library of Medicine

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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

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

ClinicalTrials.gov Identifier: NCT00311441     History of Changes
Other Study ID Numbers: M48P3
911
First Posted: April 6, 2006    Key Record Dates
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