Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules
This trial has been completed.
|Condition||tick borne encephalitis|
|Start date||March 2012|
|End date||September 2016|
|Trial size||206 participants|
|Trial identifier||NCT01562444, 2011-003255-19, 205335, V48P7E2|
The aim of this study is to investigate the immunogenicity response in adults up to 10 years after one booster dose. Data collected from this study will allow for greater information to prescribers who administer TBE vaccine, so that they can appropriately time the administration of booster vaccinations to individuals who received different vaccination schedules and who live in tick borne encephalitis endemic regions.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Antibody responses in subjects for up to 10 years following booster vaccination.
time frame: 6 to 10 years after first booster with TBE vaccination
Male or female participants at least 18 years old.
Inclusion Criteria: - Subjects who have completed prior study - V48P7E1. Exclusion Criteria: - Subjects whose antibody responses to booster vaccine received in the parent study fell below protective levels, subjects who have been exposed to TBE or flavivirus vaccine, subjects with immunosuppression.
|Official title||A Phase IV, Open-label, Single-center Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules|
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