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Tick-Borne Encephalitis (TBE) Seropersistence After First Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Grieskirchnerstr.17
Oberösterreich, , 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
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Subjects who participated in precursor Study 700401 and meet ALL of the following criteria
are eligible for participation in this study:

- Subject / parent(s) / legal guardian(s) provide(s) written informed consent
(according to national law);

- Subject provides written assent to the study according to age and capacity of
understanding;

- Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior
or FSME-IMMUN 0.5 ml during the course of precursor Study 700401;

- Blood was drawn after the first booster vaccination in precursor Study 700401;

- Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is
/ are willing to comply with the requirements of the protocol (e.g. return for
follow-up visits, completion of the Subject Diary).

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

Subjects who participated in precursor Study 700401 and meet ANY of the following criteria
are not eligible for participation in this study:

- Subject received any TBE vaccination since his / her first booster vaccination in
precursor Study 700401;

- Subject has a history of infection with or vaccination against other flaviviruses
(e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first
booster vaccination in precursor Study 700401;

- Subject is known to be HIV positive since his / her first booster vaccination in
precursor Study 700401 (a special HIV test is not required for the purpose of the
study);

- Subject received a blood product or immunoglobulins within 90 days before any blood
draw or in the period between the blood draw and the booster vaccination (as
applicable);

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

- Subject / parent(s) / legal guardian(s) is / are in a dependent relationship with the
study investigator or with a study team member. Dependent relationship includes close
relatives (i.e., children or grandchildren, partner / spouse, siblings) as well as
employees of the investigator or the site conducting the study.

NCT00894686
Pfizer
Active, not recruiting
Tick-Borne Encephalitis (TBE) Seropersistence After First Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)

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Descriptive Information
Brief Title  ICMJE Tick-Borne Encephalitis (TBE) Seropersistence After First Booster and Response to a Second Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)
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 In Children, Adolescents And Young Adults (Follow-up To Study 700401)
Brief SummaryThe main purpose of this study is to assess the seropersistence of TBE virus antibodies in children, adolescents and young adults who received the first booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Encephalitis, Tick-Borne
Intervention  ICMJE Biological: FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)
Dosage form: solution/suspension; injectable. Dosage frequency: once. Mode of administration: intramuscular.
Study Arms  ICMJE Experimental: All subjects
Assessment of seropersistence of TBE antibodies at yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination (in Study 700401), as well as antibody response to a second booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL, depending on the subject´s age. Timing of the second booster vaccination will depend on the level of serum TBE antibodies detected at the defined assessment time points. Subjects who are not protected against TBE for an entire further season (NT titer <= 20 and/or ELISA value <=126 VIE U/mL) will be invited to receive the second booster vaccination at either the 40, 48, 60, 72, 84, 96, 108, or 120-month time point.
Intervention: Biological: FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)
Publications *Poellabauer E, Angermayr R, Behre U, Zhang P, Harper L, Schmitt HJ, Erber W. Seropersistence and booster response following vaccination with FSME-IMMUN in children, adolescents, and young adults. Vaccine. 2019 May 27;37(24):3241-3250. doi: 10.1016/j.vaccine.2019.03.032. Epub 2019 Mar 27.


*   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: May 9, 2018)
179
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2009)
202
Actual Study Completion Date  ICMJE May 10, 2017
Actual Primary Completion DateMay 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects who participated in precursor Study 700401 and meet ALL of the following criteria are eligible for participation in this study:

  • Subject / parent(s) / legal guardian(s) provide(s) written informed consent (according to national law);
  • Subject provides written assent to the study according to age and capacity of understanding;
  • Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml during the course of precursor Study 700401;
  • Blood was drawn after the first booster vaccination in precursor Study 700401;
  • Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the Subject Diary).

Exclusion Criteria:

Subjects who participated in precursor Study 700401 and meet ANY of the following criteria are not eligible for participation in this study:

  • Subject received any TBE vaccination since his / her first booster vaccination in precursor Study 700401;
  • Subject has a history of infection with or vaccination against other flaviviruses (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first booster vaccination in precursor Study 700401;
  • Subject is known to be HIV positive since his / her first booster vaccination in precursor Study 700401 (a special HIV test is not required for the purpose of the study);
  • Subject received a blood product or immunoglobulins within 90 days before any blood draw or in the period between the blood draw and the booster vaccination (as applicable);
  • Subject has a known or suspected problem with drug or alcohol abuse (> 4 liters of wine/week or equivalent level of other alcoholic beverages);
  • Subject / parent(s) / legal guardian(s) is / are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner / spouse, siblings) as well as employees of the investigator or the site conducting the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 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 Austria,   Germany,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00894686
Other Study ID Numbers  ICMJE 700802
B9371021 ( Other Identifier: Alias Study Number )
2009-009324-36 ( EudraCT Number )
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
Study Director:Pfizer CT.gov Call CenterPfizer
Study Director:Eva-Maria Pöllabauer, MDBaxter Healthcare Corporation
PRS AccountPfizer
Verification DateMay 2018

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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