NCT00161798

Brief Summary

The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2001

Shorter than P25 for phase_2

Geographic Reach
1 country

23 active sites

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

September 1, 2001

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

First QC Date

September 8, 2005

Last Update Submit

May 20, 2015

Conditions

Tick-borne Encephalitis

Interventions

Tick-borne encephalitis vaccineBIOLOGICAL

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male and female children will be eligible for participation in this study if:
  • they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday);
  • they are clinically healthy;
  • their legal representative - and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent;
  • their legal representative agrees to keep a Volunteer Diary.
  • negative pregnancy test at study start;
  • they agree to employ adequate birth control measures for the duration of the study.

You may not qualify if:

  • Children will be excluded from participation in this study if they:
  • have a history of any previous TBE vaccination;
  • have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA \> 126 VIEU/ml and / or neutralization test \> 1:10);
  • have a history of allergic reactions, in particular to one of the components of the vaccine;
  • have received antipyretics within 4 hours prior to the first TBE vaccination;
  • suffer from a disease that cannot be effectively treated or stabilized;
  • suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions;
  • suffer from chronic, degenerative and / or inflammatory disease of the central nervous system;
  • are known to be HIV positive (a special HIV test is not required for the purpose of the study);
  • suffer from a febrile illness at study entry;
  • have a history of vaccination against yellow fever and / or Japanese B-encephalitis;
  • are participating simultaneously in another clinical trial.
  • if female, are pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Neuschwansteinstrasse 5

Augsburg, 86163, Germany

Location

Marktplatz 33

Bad Saulgau, 88348, Germany

Location

Hauptstrasse 9

Bietigheim-Bissingen, 74321, Germany

Location

Salzgasse 11

Calw, 75365, Germany

Location

Mohrenstrasse 8

Coburg, 96450, Germany

Location

Bahnhofstrasse 1

Elzach, 79215, Germany

Location

Rheinstrasse 13

Ettenheim, 77955, Germany

Location

Peter-Seifert Strasse 5

Gersfeld, 36129, Germany

Location

Solothurner Strasse 2

Heilbronn, 74072, Germany

Location

Hauptstraße 240

Kehl, 77694, Germany

Location

Schwarzwaldstrasse 20

Kirchzarten, 79199, Germany

Location

Altoettingerstrasse 3

Landsberg, 86899, Germany

Location

Rastatter Strasse 7

Mannheim-Secken, 68239, Germany

Location

Wilhelmstrasse 25

Metzingen, 72555, Germany

Location

Heubischer Strasse 39

Neustadt/Cbg, 96465, Germany

Location

Dohmbuehlerstrasse 8

Nuremberg, 90449, Germany

Location

Schwarzwaldstrasse 18

Oberkirch, 77704, Germany

Location

Wilhelmstrasse 7

Offenburg, 77654, Germany

Location

Asternweg 11a

Offenburg, 77656, Germany

Location

Bergstrasse 27

Rottweil, 78628, Germany

Location

Berneckstrasse 19

Schrammberg, 78713, Germany

Location

Hauptstrasse 11

Tegernsee, 83681, Germany

Location

Broner Platz 6

Weingarten, 88250, 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

  • Ulrich Behre, MD

    Hauptstrasse 240, 77694 Kehl, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 13, 2005

Study Start

September 1, 2001

Study Completion

March 1, 2002

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

DE(23)