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TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Grieskirchner Strasse 17
Wels, Upper Austria, 4600 Austria
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
3-18 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Participated in Baxter study 209 and:

- They and/or their parents / legal guardians understand the nature of the study and
agree to its provisions

- Written informed consent is available from the parents / legal guardians according to
national law

- Written informed assent is available from the child/adolescent according to age and
capacity of understanding

- They received the third vaccination with FSME-IMMUN 0.25 ml during the course of
Baxter study 209

- Blood was drawn after their third vaccination during the course of Baxter study 209

- They showed an ELISA concentration > 126 VIE U/ml and / or a NT titer >=10 after the
third vaccination in Baxter study 209

- They or their parents / legal guardians agree to keep a Subject Diary

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

- Received any TBE vaccination since their third vaccination with FSME-IMMUN 0.25 ml

- Have a history of infection with or vaccination against other flaviviruses (Dengue
fever, yellow fever and / or Japanese B-encephalitis virus) since their third
vaccination with FSME-IMMUN 0.25 ml

- Are known to be HIV positive (a special HIV test is not required for the purpose of
the study) since their third vaccination with FSME-IMMUN 0.25 ml

- Received a blood transfusion or immunoglobulins within 30 days of the first and second
blood draw (as applicable)

- Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week
or equivalent level of other alcoholic beverages)

- Have participated in another Baxter vaccine study within the last six months (with the
exception of follow-up studies)

Subjects will not be eligible for booster vaccination if they:

- Do not meet the inclusion / exclusion criteria

- Are not clinically healthy, (i.e. the physician would have reservations vaccinating
with a TBE vaccine outside the scope of a clinical trial)

- Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment
(e.g. systemic corticosteroids) that can be expected to influence immunological
functions

- Have shown an allergic reaction to one of the components of the vaccine since their
third vaccination in Baxter study 209

- Have donated blood or plasma within 30 days of the booster vaccination if female of
childbearing potential - are pregnant or breastfeeding before the booster vaccination
(positive pregnancy test result at the medical examination before the booster
vaccination)

- Are simultaneously participating in another clinical trial including administration of
an investigational product within six weeks prior to the booster vaccination until the
end of the study

Subjects who meet the inclusion/exclusion criteria, but have a febrile illness (body
temperature >=38.0°C, measured orally) at the scheduled time of vaccination will not be
vaccinated until their body temperature returns to normal.

Subjects who received any vaccination within 4 weeks prior to the booster vaccination will
not be vaccinated until an interval of four weeks has passed.

If subjects received antipyretics within 4 hours prior to the intended TBE vaccination, the
vaccination should be performed at a later time.

Females of childbearing potential will only be vaccinated if they agree to employ adequate
birth control measures from 4 weeks before the booster vaccination until the end of the
study.

NCT00161967
Pfizer
Completed
TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)

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TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)
Open-label Follow-up Study to Investigate the Seropersistence of TBE Antibodies and the Booster Response to a Tick-borne Encephalitis Vaccine in Children and Adolescents Aged 3 - 18 Years

The purpose of this study is to assess the seropersistence of TBE antibodies in children and adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34 months after completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations during the predecessor study 209), as well as the immune response to a booster vaccination with FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml administered 36 months after the third vaccination (in Study 209).

Protocol amendment of October 2006: The study has been prolonged for children and adolescents who still showed highly positive TBE virus antibody concentrations at approximately 3 years after the third vaccination and therefore did not receive a booster vaccination at this time point. Further follow-up of TBE antibody persistence is now included for these subjects at 46 and 58 months after the third vaccination (in Study 209), as well as a booster vaccination offered at either 48 or 60 months after the third vaccination (in Study 209), depending on individual TBE antibody levels.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Subjects receive one vaccination with either FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml, depending on their age.
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
375
November 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participated in Baxter study 209 and:
  • They and/or their parents / legal guardians understand the nature of the study and agree to its provisions
  • Written informed consent is available from the parents / legal guardians according to national law
  • Written informed assent is available from the child/adolescent according to age and capacity of understanding
  • They received the third vaccination with FSME-IMMUN 0.25 ml during the course of Baxter study 209
  • Blood was drawn after their third vaccination during the course of Baxter study 209
  • They showed an ELISA concentration > 126 VIE U/ml and / or a NT titer >=10 after the third vaccination in Baxter study 209
  • They or their parents / legal guardians agree to keep a Subject Diary

Exclusion Criteria:

  • Received any TBE vaccination since their third vaccination with FSME-IMMUN 0.25 ml
  • Have a history of infection with or vaccination against other flaviviruses (Dengue fever, yellow fever and / or Japanese B-encephalitis virus) since their third vaccination with FSME-IMMUN 0.25 ml
  • Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.25 ml
  • Received a blood transfusion or immunoglobulins within 30 days of the first and second blood draw (as applicable)
  • Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
  • Have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)

Subjects will not be eligible for booster vaccination if they:

  • Do not meet the inclusion / exclusion criteria
  • Are not clinically healthy, (i.e. the physician would have reservations vaccinating with a TBE vaccine outside the scope of a clinical trial)
  • Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
  • Have shown an allergic reaction to one of the components of the vaccine since their third vaccination in Baxter study 209
  • Have donated blood or plasma within 30 days of the booster vaccination if female of childbearing potential - are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination)
  • Are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study

Subjects who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature >=38.0°C, measured orally) at the scheduled time of vaccination will not be vaccinated until their body temperature returns to normal.

Subjects who received any vaccination within 4 weeks prior to the booster vaccination will not be vaccinated until an interval of four weeks has passed.

If subjects received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.

Females of childbearing potential will only be vaccinated if they agree to employ adequate birth control measures from 4 weeks before the booster vaccination until the end of the study.

Sexes Eligible for Study: All
3 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Poland
 
 
NCT00161967
700401
Yes
Not Provided
Not Provided
Martin Kraft, Clinical Project Manager, Baxter Healthcare Corporation
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.

BY PHONE

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1-800-718-1021

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Contact

[email protected]



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