- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00163540
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)
May 20, 2015 updated by: Pfizer
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Antwerp, Belgium, 2060
- SGS Biopharma Research Unit Stuivenberg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 66 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Baxter BioScience Investigator, MD, Baxter BioScience
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
May 21, 2015
Last Update Submitted That Met QC Criteria
May 20, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Tick-Borne Diseases
- Encephalitis
- Encephalitis, Tick-Borne
- Anti-Infective Agents
- Disinfectants
- Formaldehyde
Other Study ID Numbers
- 690501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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