Clinical trial NCT01106482: An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE
Official title: A Phase IV, Open-label, Multi-center Follow-up Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tick Borne Encephalitis (TBE)
Keywords: TBE
Tick Borne Encephalitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 126
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine


Eligibility criteria: Inclusion Criteria:

* Healthy study subjects from the parent study who completed the primary vaccination series, with parental or legal guardian informed consent

Exclusion Criteria:

* Subjects who did not receive complete schedule of primary vaccination in the parent study
* Subjects enrolled in other investigational studies at the same time and within the last three months
* Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Primary outcomes:
measure: Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination
timeFrame: 3 years after vaccination
measure: Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination
timeFrame: 4 years after vaccination
measure: Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination
timeFrame: 5 years after vaccination
Secondary outcomes:
measure: Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination
timeFrame: 3 years after vaccination
measure: Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination
timeFrame: 4 years after vaccination
measure: Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination
timeFrame: 5 years after vaccination
Other outcomes:
Locations:
city: Ehingen
country: Germany
facility: Winkelhoferstr. 3
city: Kaufering
country: Germany
facility: Fuggerplatz 1
city: Kehl
country: Germany
facility: Hauptstrasse 240
city: Ludwigsburg
country: Germany
facility: Bismarckstr. 3
city: Oberkirch
country: Germany
facility: Am Marktplatz 8
city: Oberstenfeld
country: Germany
facility: Großbottwarer Str. 47
city: Offenburg
country: Germany
facility: Wilhelmstr. 7
city: Stuttgart
country: Germany
facility: Stuttgarter Str. 74
city: Traunreut
country: Germany
facility: Martin-Niemöller-Str. 2
city: Weilheim
country: Germany
facility: Murnauer Str. 3
Study officials:
References:
citation: Wittermann C, Izu A, Petri E, Gniel D, Fragapane E. Five year follow-up after primary vaccination against tick-borne encephalitis in children. Vaccine. 2015 Apr 8;33(15):1824-9. doi: 10.1016/j.vaccine.2015.02.038. Epub 2015 Feb 26.