NCT00161746

Brief Summary

The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1998

Shorter than P25 for phase_2

Geographic Reach
1 country

7 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

April 1, 1998

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1999

Completed
6.3 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

Encephalitis, Tick-borne

Keywords

Tick-Borne Encephalitis

Interventions

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)BIOLOGICAL

Eligibility Criteria

Age6 Months - 47 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male and female children aged between 6 and 47 months
  • No history of any previous TBE vaccination
  • Clinically healthy
  • Informed consent provided by the parents

You may not qualify if:

  • History of allergic reactions, in particular allergic reactions to one of the components of the vaccine
  • Suffering from a disease that cannot be effectively treated or stabilised
  • Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions
  • Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system
  • HIV-positivity (no special HIV test required for the purpose of the study)
  • Suffering from a febrile disease
  • History of vaccination against yellow fever and/or Japanese encephalitis
  • Participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Wiener Strasse 50/2

Kapfenberg, 8605, Austria

Location

Erzherzog Johann Strasse 9

Leoben, 8700, Austria

Location

Fronleichnamsweg 10

Liezen, 8940, Austria

Location

Hauptstrasse 61

Linz, 4040, Austria

Location

Brauhausgasse 1

Mürzzuschlag, 8680, Austria

Location

Conrad-von-Hötzendorf Strasse

Voitsberg, 8570, Austria

Location

Grieskirchner Strasse 17

Wels, 4600, Austria

Location

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Interventions

Vaccines

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

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Baxter BioScience Investigator

    Baxter Healthcare Corporation

    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

April 1, 1998

Study Completion

June 1, 1999

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

AU(7)