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Trial record 11 of 31 for:    "Encephalitis, Tick-Borne"
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Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161746
First received: September 8, 2005
Last updated: June 12, 2006
Last verified: June 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Encephalitis, Tick-Borne
 Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Multicentre Randomized Double-Blind Phase II/III Study on the Safety and Immunogenicity of Three Vaccinations With TICOVAC in Two Dosages in Healthy Children Aged Between Six Months and Three Years

Resource links provided by NLM:

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Study Start Date: April 1998
Estimated Study Completion Date: June 1999
  Eligibility

Ages Eligible for Study:   6 Months to 47 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161746

Locations
Austria
Wiener Strasse 50/2
Kapfenberg, Austria, 8605
Erzherzog Johann Strasse 9
Leoben, Austria, 8700
Fronleichnamsweg 10
Liezen, Austria, 8940
Hauptstrasse 61
Linz, Austria, 4040
Brauhausgasse 1
Mürzzuschlag, Austria, 8680
Conrad-von-Hötzendorf Strasse
Voitsberg, Austria, 8570
Grieskirchner Strasse 17
Wels, Austria, 4600
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00161746     History of Changes
Other Study ID Numbers: 146A
Study First Received: September 8, 2005
Last Updated: June 12, 2006
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Baxter Healthcare Corporation:
Tick-Borne Encephalitis

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
 Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 23, 2013