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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)

Last updated on March 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.
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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.
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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 and Response to a Second Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)

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