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TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Hospital in Debica - Zespol Opieki Zdrowotnej w Debicy
Debica, , 33-200 Poland
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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who participated in Study 223 will be eligible for participation in this
study if:

- they understand the nature of the study, agree to its provisions and provide written
informed consent

- they received the first booster vaccination with FSME-IMMUN 0.5ml during the course
of study 223

- blood was drawn after their first booster vaccination in Study 223.

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

Subjects will be excluded from participation in this study if they:

- received any TBE vaccination since their first booster vaccination with FSME-IMMUN
0.5ml

- have a history of infection with or vaccination against other flaviviruses (e.g.
dengue fever, yellow fever, Japanese B-encephalitis) since their first booster
vaccination with FSME-IMMUN 0.5ml

- are known to be HIV positive (a special HIV test is not required for the purpose of
the study) since their first booster vaccination with FSME-IMMUN 0.5ml

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

Subjects will not be eligible for booster vaccination if they:

- are not clinically healthy, (i. e. the physician would have reservations vaccinating
with FSME-IMMUN 0.5ml 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

- are females of childbearing potential and are pregnant or breastfeeding before the
booster vaccination (positive pregnancy test result at the medical examination before
the booster vaccination)

- have shown an allergic reaction to one of the components of the vaccine since their
first booster vaccination in Study 223

- 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

- do not agree to keep a Subject Diary.

- Subjects who meet the eligibility 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 have been administered any vaccination within 2 weeks prior to the
booster vaccination will not be vaccinated until an interval of two weeks has passed.

- If subjects have received antipyretics within 4 hours prior to the scheduled time of
vaccination, the vaccination should be performed at a later time.

- If a subject had a tick-bite within 4 weeks of the scheduled booster vaccination, the
vaccination shall be delayed such that an interval of 4 weeks has passed since the
tick-bite in order to avoid any interference with diagnostic assays in the event of a
TBE infection.

- If a subject has donated blood or plasma or has received a blood transfusion or
immunoglobulins within 4 weeks of the scheduled booster vaccination, the vaccination
shall be delayed until an interval of 4 weeks has passed.

NCT00503529
Pfizer
Completed
TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)

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Descriptive Information
Brief Title  ICMJE TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)
Official Title  ICMJE Open-label Phase IV Study to Investigate the Seropersistence of Tick Borne Encephalitis (TBE) Virus Antibodies After the First Booster and the Response to a Second Booster Vaccination With FSME-IMMUN 0.5ml in Adults (Follow Up to Study 223)
Brief Summary

The purpose of this study is to assess:

  • TBE antibody persistence 24, 34, 46 and 58 months (as applicable) after the first booster TBE vaccination with FSME-IMMUN 0.5ml given in Study 223, by means of ELISA (IMMUNOZYM FSME IgG) and Neutralization test (NT),
  • TBE antibody response to a second booster vaccination with FSME-IMMUN 0.5ml in the present study, by means of ELISA and NT,
  • Safety of FSME-IMMUN 0.5ml after the second booster vaccination.
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: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Vaccination by intramuscular injection into the right or left upper arm (musculus deltoideus)
Other Name: FSME-IMMUN 0.5 ml
Study Arms  ICMJE Not Provided
Publications *Konior R, Brzostek J, Poellabauer EM, Jiang Q, Harper L, Erber W. Seropersistence of TBE virus antibodies 10 years after first booster vaccination and response to a second booster vaccination with FSME-IMMUN 0.5mL in adults. Vaccine. 2017 Jun 16;35(28):3607-3613. doi: 10.1016/j.vaccine.2017.03.059. Epub 2017 May 22.


*   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
Actual Enrollment  ICMJE
 (submitted: December 16, 2010)
314
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2007)
300
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion DateJuly 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who participated in Study 223 will be eligible for participation in this study if:
  • they understand the nature of the study, agree to its provisions and provide written informed consent
  • they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223
  • blood was drawn after their first booster vaccination in Study 223.

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

  • received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml
  • have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml
  • are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their first booster vaccination with FSME-IMMUN 0.5ml
  • have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages).

Subjects will not be eligible for booster vaccination if they:

  • are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml 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
  • are females of childbearing potential and are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination)
  • have shown an allergic reaction to one of the components of the vaccine since their first booster vaccination in Study 223
  • 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
  • do not agree to keep a Subject Diary.
  • Subjects who meet the eligibility 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 have been administered any vaccination within 2 weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed.
  • If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later time.
  • If a subject had a tick-bite within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed such that an interval of 4 weeks has passed since the tick-bite in order to avoid any interference with diagnostic assays in the event of a TBE infection.
  • If a subject has donated blood or plasma or has received a blood transfusion or immunoglobulins within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed until an interval of 4 weeks has passed.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00503529
Other Study ID Numbers  ICMJE 690701
EUDRACT # 2007-000440-27
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Ryszard Konior, MDThe John Paul II Hospital, Krakow, Poland
PRS AccountPfizer
Verification DateMay 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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