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.

Sponsored by:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00161746

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 II Phase III

MedlinePlus related topics: Encephalitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
Grieskirchner Strasse 17
Wels, Austria, 4600
Hauptstrasse 61
Linz, Austria, 4040
Erzherzog Johann Strasse 9
Leoben, Austria, 8700
Wiener Strasse 50/2
Kapfenberg, Austria, 8605
Fronleichnamsweg 10
Liezen, Austria, 8940
Conrad-von-Hötzendorf Strasse
Voitsberg, Austria, 8570
Brauhausgasse 1
Mürzzuschlag, Austria, 8680

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Principal Investigator:

Baxter BioScience Investigator

Baxter Healthcare Corporation

More Information

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

Keywords provided by Baxter Healthcare Corporation:

Tick-Borne Encephalitis

Study placed in the following topic categories:

Virus Diseases
Tick-borne encephalitis
Central Nervous System Infections
Central Nervous System Diseases
Healthy

Arbovirus Infections
Brain Diseases
Tick-Borne Diseases
Encephalitis
Encephalitis, Tick-Borne

Additional relevant MeSH terms:

Encephalitis, Viral
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections

Nervous System Diseases
Central Nervous System Viral Diseases
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on January 16, 2009