Status:
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)
Lead Sponsor:
Pfizer
Conditions:
Encephalitis, Tick-Borne
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 26 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2017
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00894686
Start Date
April 26 2009
End Date
May 10 2017
Last Update
December 17 2018
Active Locations (4)
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1
Grieskirchnerstr.17
Oberösterreich, Austria
2
Untergraben 2
Oberösterreich, Austria
3
Dr. Ulrich Behre
Baden-Württemberg, Germany
4
Niepubliczny Zakład Opieki Zdrowotnej Ośrodek Zdrowia w Lipsku
Zamość, Poland