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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)

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00163540
First received: September 8, 2005
Last updated: October 18, 2006
Last verified: October 2006
  Purpose

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 Intervention Phase
Encephalitis, Tick-Borne
Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Study Start Date: May 2005
Estimated Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   17 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00163540

Locations
Belgium
SGS Biopharma Research Unit Stuivenberg
Antwerp, Belgium, 2060
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator, MD Baxter BioScience
  More Information

No publications provided by Baxter Healthcare Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00163540     History of Changes
Other Study ID Numbers: 690501
Study First Received: September 8, 2005
Last Updated: October 18, 2006
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Baxter Healthcare Corporation:
tick-borne encephalitis

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
RNA Virus Infections
Tick-Borne Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014