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Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

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: NCT00163540
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : May 21, 2015
Information provided by:

Brief Summary:
The objective of this study is to investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.

Condition or disease Intervention/treatment Phase
Encephalitis, Tick-borne Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open-Label, Follow-up, Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated Using a Rapid Immunization Schedule (Follow-up to Study 225)
Study Start Date : May 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 66 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male and female subjects who:
  • received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225
  • understand the nature of the study, agree to its provisions and provide written informed consent
  • are clinically healthy (i.e. the physician would have no reservation vaccinating with FSME-IMMUN 0.5 ml outside the scope of the clinical trial)
  • have a negative pregnancy test result at the first medical examination (if female and capable of bearing children)
  • agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children)
  • agree to keep a Subject Diary

Exclusion Criteria:

Subjects who:

  • have already been administered a third TBE vaccination elsewhere since receiving two vaccinations in Study 225
  • have a history of infection with, or vaccination against, other flaviviruses since participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis)
  • have had an allergic reaction to one of the components of the vaccine since participation in Study 225
  • suffer from a disease (e.g. autoimmune disease, immunodeficiency) or are undergoing a form of treatment (e.g., systemic corticosteroids) that can be expected to influence immunological functions
  • have a known or suspected problem with drug or alcohol abuse (>4 liters wine/week or equivalent doses of other alcoholic beverages)
  • have donated blood or plasma within 30 days of study entry
  • have received a blood transfusion or immunoglobulins within 30 days of study entry
  • are known to be HIV positive (an HIV test is not required specifically for this study)
  • are simultaneously participating in another clinical trial including administration of an investigational product
  • have participated in any other clinical study within 6 weeks prior to study start
  • have participated in another Baxter vaccine study in the past 6 months (with the exception of follow-up studies)
  • For female subjects: pregnancy or lactation

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): NCT00163540

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SGS Biopharma Research Unit Stuivenberg
Antwerp, Belgium, 2060
Sponsors and Collaborators
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Principal Investigator: Baxter BioScience Investigator, MD Baxter BioScience

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00163540     History of Changes
Other Study ID Numbers: 690501
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Keywords provided by Pfizer:
tick-borne encephalitis
Additional relevant MeSH terms:
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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
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents