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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)

Primary Purpose

Encephalitis, Tick-borne

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Encephalitis, Tick-borne focused on measuring tick-borne encephalitis

Eligibility Criteria

17 Years - 66 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SGS Biopharma Research Unit Stuivenberg

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
May 20, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00163540
Brief Title
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
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Tick-borne
Keywords
tick-borne encephalitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baxter BioScience Investigator, MD
Organizational Affiliation
Baxter BioScience
Official's Role
Principal Investigator
Facility Information:
Facility Name
SGS Biopharma Research Unit Stuivenberg
City
Antwerp
ZIP/Postal Code
2060
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
21592984
Citation
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. doi: 10.1093/infdis/jir122.
Results Reference
derived

Learn more about this trial

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)

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