FSME IMMUN NEW Follow-Up to Study 205 in Children Aged 6 to 16 Years

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161889
First received: September 8, 2005
Last updated: June 12, 2006
Last verified: June 2006

September 8, 2005
June 12, 2006
February 2002
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Complete list of historical versions of study NCT00161889 on ClinicalTrials.gov Archive Site
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FSME IMMUN NEW Follow-Up to Study 205 in Children Aged 6 to 16 Years
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 6 to 16 Years

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 volunteers who completed two vaccinations in one of the three treatment groups of Baxter study 205 (safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy volunteers aged 6 to 16 years).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
615
August 2002
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Inclusion criteria:

All volunteers who participated in Baxter study 205 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 205
  • They and/or their legal guardian understand the nature of the study, agree to its provisions and give written informed consent

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 205
  • Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 205
  • 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 205
  • Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 205
  • Had received an investigational new drug within 6 weeks prior to study start
  • If female and capable of bearing children – have a positive pregnancy test at the first medical examination
Both
6 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00161889
207
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Baxter Healthcare Corporation
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Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation
Baxter Healthcare Corporation
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP