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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.
Information provided by:
Pfizer Identifier:
First received: September 8, 2005
Last updated: May 20, 2015
Last verified: May 2015
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
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00161746

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
Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation
  More Information Identifier: NCT00161746     History of Changes
Other Study ID Numbers: 146A
Study First Received: September 8, 2005
Last Updated: May 20, 2015

Keywords provided by Pfizer:
Tick-Borne Encephalitis

Additional relevant MeSH terms:
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 processed this record on August 17, 2017