Trial record 12 of 32 for:    "Encephalitis, Tick-Borne"

Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161954
First received: September 8, 2005
Last updated: October 19, 2006
Last verified: October 2006
  Purpose

The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.


Condition Intervention Phase
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Open Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Study Start Date: March 2004
Estimated Study Completion Date: May 2004
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Understanding the nature of the study, agreement to its provisions and written informed consent
  • Written informed consent of subject´s parents / legal guardians (if subject is under 18 years of age)
  • Aged >= 16 years (from the 16th birthday) to <= 65 years (to the last day before the 66th birthday)
  • Clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial)
  • Negative pregnancy test result at the first medical examination (if female and capable of bearing children)
  • Agreeing to employ adequate birth control measures for the duration of the study (if female and capable of bearing children)
  • Agreeing to keep a subject diary.

Exclusion Criteria:

  • History of any previous TBE vaccination
  • History of TBE infection
  • History of infection with other flaviviruses
  • History of vaccination against yellow fever and/or Japanese B-encephalitis
  • History of allergic reactions, in particular to one of the components of the vaccine
  • Suffering from a disease (e.g. autoimmune disease) or undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
  • Known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
  • Donation of blood or plasma within one month of study start
  • Having received a blood transfusion or immunoglobulins within one month of study entry
  • HIV positivity (an HIV test is not required specifically for the purpose of this study
  • Simultaneous participation in another clinical trial including administration of an investigational product
  • Participating in any other clinical study within six weeks prior to study start
  • Participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)
  • Pregnancy or lactation (if female)
  • Having received any other vaccination within two weeks prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161954

Locations
Belgium
SGS Biopharma Research Unit Stuivenberg
Antwerp, Belgium, 2060
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator 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: NCT00161954     History of Changes
Other Study ID Numbers: 225
Study First Received: September 8, 2005
Last Updated: October 19, 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

ClinicalTrials.gov processed this record on April 17, 2014