This trial is active, not recruiting.

Condition tick borne encephalitis
Treatment blood sampling
Phase phase 4
Sponsor Novartis
Collaborator Novartis Vaccines
Start date March 2012
End date September 2016
Trial size 206 participants
Trial identifier NCT01562444, 2011-003255-19, 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Blood sampling
blood sampling
Annual blood draws

Primary Outcomes

Antibody responses in subjects for up to 10 years following booster vaccination.
time frame: 6 to 10 years after first booster with TBE vaccination

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Novartis.