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

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

October 19, 2006

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00161954 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Encephalitis, Tick-Borne

Intervention ^ICMJE

Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Study Arms / Comparison Groups

Publications *

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

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00161954

Responsible Party

Study ID Numbers ^ICMJE

225

Study Sponsor ^ICMJE

Baxter Healthcare Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Baxter BioScience Investigator

Baxter BioScience

Information Provided By

Baxter Healthcare Corporation

Verification Date

October 2006

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