Trial record 21 of 36 for:    "Encephalitis, Tick-Borne"

FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 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: NCT00161850
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
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Brief Summary:
The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 615 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Follow-up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 1 to 6 Years
Study Start Date : February 2002
Study Completion Date : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

All volunteers who participated in Baxter study 199 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:

  • They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 199
  • Written informed consent from the legal guardian is available.

Exclusion Criteria:

There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.

Volunteers will be excluded from vaccination and consecutive visits in this study if they:

  • Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)
  • Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 199
  • Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199
  • Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
  • Have received banked human blood or immunoglobulins within one month of study entry
  • Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 199
  • Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 199
  • Had received an investigational new drug within 6 weeks prior to study start

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): NCT00161850

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Broner Platz 6
Weingarten, Germany, D-88250
Sponsors and Collaborators
Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation Identifier: NCT00161850     History of Changes
Other Study ID Numbers: 206
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

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