Official Title: “Open-Label Phase 3b Clinical Study to Evaluate the Immunogenicity and Safety of FSME-IMMUN 0.5 ml With the First and Second Vaccination Being Administered According to a Rapid Immunization Schedule in Healthy Adults Aged 16 Years or Older”

The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.

Study Type: Interventional

Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

• Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl

Primary Measures

• Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined.

Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

• Understand the nature of the study, agree to its provisions and provide written informed consent (assent if the subjects is under 18 years of age);
• Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age);
• Are aged >= 16 years (from the 16th birthday) at screening;
• Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a 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 will be excluded from participation in this study if they:

• Have a history of any previous tick-borne encephalitis (TBE) vaccination;
• Have a history of TBE infection;
• Have a history of infection with or vaccination against other flaviviruses (e.g.
• dengue fever, yellow fever, Japanese B-encephalitis);
• Have a history of allergic reactions, in particular to one of the components of the vaccine;
• Suffer from a disease (e.g. autoimmune disease) 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 level 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 the purpose of this study);
• Are simultaneously participating in another clinical trial including administration of an investigational product;
• Have participated in any other clinical study within six weeks prior to study entry;
• Are pregnant or breastfeeding (if female);
• Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
• Have received any other vaccination within two weeks prior to study entry.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Baxter Healthcare Corporation

Overall Clinical Trial Officials and Contacts

Baxter BioScience Investigator, MD Principal Investigator Baxter BioScience  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00460486

Study ID Number: 690601

ClinicalTrials.gov Identifier: NCT00460486

Health Authority: Poland: Ministry of Health