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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00161746
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Encephalitis, Tick-borne Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 1998
Study Completion Date : June 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00161746

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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
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Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation

Layout table for additonal information Identifier: NCT00161746     History of Changes
Other Study ID Numbers: 146A
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Keywords provided by Pfizer:
Tick-Borne Encephalitis
Additional relevant MeSH terms:
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Encephalitis, Tick-Borne
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs