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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)

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
SGS Biopharma Research Unit Stuivenberg
Antwerp, , 2060 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-borne Encephalitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
17-66 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00163540
Pfizer
Completed
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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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 SummaryThe 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Encephalitis, Tick-borne
Intervention  ICMJE Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Study Arms  ICMJE 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. doi: 10.1093/infdis/jir122.


*   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
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE June 2005
Primary Completion DateNot 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 17 Years to 66 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00163540
Other Study ID Numbers  ICMJE 690501
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Baxter BioScience Investigator, MDBaxter BioScience
PRS AccountPfizer
Verification DateMay 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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