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:
Pfizer
ClinicalTrials.gov Identifier:
NCT00161746
First received: September 8, 2005
Last updated: May 20, 2015
Last verified: May 2015
  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:


Further study details as provided by Pfizer:

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

Ages Eligible for Study:   6 Months to 47 Months   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pfizer
Investigators
Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation
  More Information

ClinicalTrials.gov Identifier: NCT00161746     History of Changes
Other Study ID Numbers: 146A 
Study First Received: September 8, 2005
Last Updated: May 20, 2015
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Pfizer:
Tick-Borne Encephalitis

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
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

ClinicalTrials.gov processed this record on August 25, 2016