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

This study has been completed.

First Received: April 3, 2006 Last Updated: March 14, 2008 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00311441

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 IV

MedlinePlus related topics: Encephalitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

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

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

Keywords provided by Novartis:

TBE, children, vaccine

Study placed in the following topic categories:

Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
Healthy
Arbovirus Infections

Brain Diseases
Tick-Borne Diseases
Encephalitis
Encephalitis, Tick-Borne

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Viral Diseases
Brain Diseases
Encephalitis

Tick-Borne Diseases
Encephalitis, Tick-Borne
Virus Diseases
Encephalitis, Viral
Central Nervous System Infections
Arbovirus Infections
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on May 07, 2009