NCT00311441

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
Last Updated

March 17, 2008

Status Verified

March 1, 2008

First QC Date

April 3, 2006

Last Update Submit

March 14, 2008

Conditions

Encephalitis, Tick-Borne

Keywords

TBE, children, vaccine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Tick-Borne Encephalitis vaccineBIOLOGICAL

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy male and female children, 1 to 10 years of age.

You may not qualify if:

  • Subjects with documented evidence of TBE
  • Subjects, who have been previously vaccinated against TBE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Weilheim, Germany

Location

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesTick-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • Drug Information Services

    Novartis Vaccines & Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 6, 2006

Study Start

March 1, 2005

Last Updated

March 17, 2008

Record last verified: 2008-03

Locations

DE(1)