Trial record 10 of 32 for:    "Encephalitis, Tick-Borne"

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
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
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Formaldehyde
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014