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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.
Study NCT00161954   Information provided by Baxter Healthcare Corporation
First Received: September 8, 2005   Last Updated: October 19, 2006   History of Changes

September 8, 2005
October 19, 2006
March 2004
 
 
 
Complete list of historical versions of study NCT00161954 on ClinicalTrials.gov Archive Site
 
 
 
Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years
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

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.

 
Phase IV
Interventional
Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
May 2004
 

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
Both
16 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00161954
 
225
Baxter Healthcare Corporation
 
Principal Investigator: Baxter BioScience Investigator Baxter BioScience
Baxter Healthcare Corporation
October 2006

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