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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 December 17, 2017

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

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Tick-Borne Encephalitis (TBE) Seropersistence After First Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)
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)
The 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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Encephalitis, Tick-Borne
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.
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)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
May 2017
May 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Poland
 
 
NCT00894686
700802
B9371021 ( Other Identifier: Alias Study Number )
2009-009324-36 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Eva-Maria Pöllabauer, MD Baxter Healthcare Corporation
Pfizer
July 2017

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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