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

Primary Purpose

Encephalitis, Tick-borne

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
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

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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
NCT00161954
Brief Title
Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baxter BioScience Investigator
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

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

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