Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

This study has been completed.

Sponsor:

Information provided by:

Baxter Healthcare Corporation

ClinicalTrials.gov Identifier:

NCT00163540

First received: September 8, 2005

Last updated: October 18, 2006

Last verified: October 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

October 18, 2006

Start Date ^ICMJE

May 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00163540 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

Official Title ^ICMJE

Open-Label, Follow-up, Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated Using a Rapid Immunization Schedule (Follow-up to Study 225)

Brief Summary

The objective of this study is to investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Encephalitis, Tick-Borne

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Orlinger KK, Hofmeister Y, Fritz R, Holzer GW, Falkner FG, Unger B, Loew-Baselli A, Poellabauer EM, Ehrlich HJ, Barrett PN, Kreil TR. A tick-borne encephalitis virus vaccine based on the European prototype strain induces broadly reactive cross-neutralizing antibodies in humans. J Infect Dis. 2011 Jun 1;203(11):1556-64.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

June 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male and female subjects who:
received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225
understand the nature of the study, agree to its provisions and provide written informed consent
are clinically healthy (i.e. the physician would have no reservation vaccinating with FSME-IMMUN 0.5 ml outside the scope of the 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 who:

have already been administered a third TBE vaccination elsewhere since receiving two vaccinations in Study 225
have a history of infection with, or vaccination against, other flaviviruses since participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis)
have had an allergic reaction to one of the components of the vaccine since participation in Study 225
suffer from a disease (e.g. autoimmune disease, immunodeficiency) 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 doses 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 this study)
are simultaneously participating in another clinical trial including administration of an investigational product
have participated in any other clinical study within 6 weeks prior to study start
have participated in another Baxter vaccine study in the past 6 months (with the exception of follow-up studies)
For female subjects: pregnancy or lactation

Gender

Both

Ages

17 Years to 66 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 Number ^ICMJE

NCT00163540

Other Study ID Numbers ^ICMJE

690501

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Baxter Healthcare Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Baxter BioScience Investigator, MD

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

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