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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.
Information provided by:
Pfizer Identifier:
First received: September 8, 2005
Last updated: May 20, 2015
Last verified: May 2015
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 Pfizer:

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

Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00161954

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00161954     History of Changes
Other Study ID Numbers: 225
Study First Received: September 8, 2005
Last Updated: May 20, 2015

Keywords provided by Pfizer:
Tick-Borne Encephalitis

Additional relevant MeSH terms:
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 processed this record on April 27, 2017