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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

Last updated on October 4, 2018

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
16-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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

NCT00161954
Pfizer
Completed
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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Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years
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
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.
Not Provided
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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Not Provided
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*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
May 2004
Not Provided

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
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00161954
225
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Principal Investigator: Baxter BioScience Investigator Baxter BioScience
Pfizer
May 2015

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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