Clinical trial NCT01562444: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tick Borne Encephalitis
Virus Diseases
Keywords: Long term immunogenicity study
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2012-03-23
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2
timeFrame: At Year 6
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
timeFrame: At Year 7
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
timeFrame: At Year 8
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
timeFrame: At Year 9
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
timeFrame: At Year 10
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
timeFrame: At Year 6
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
timeFrame: At Year 7
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
timeFrame: At Year 8
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
timeFrame: At Year 9
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
timeFrame: At Year 10
measure: Evaluation of Geometric Mean Antibody Titers (GMTs)
timeFrame: At Year 6
measure: Evaluation of GMTs
timeFrame: At Year 7
measure: Evaluation of GMTs
timeFrame: At year 8
measure: Evaluation of GMTs
timeFrame: At Year 9
measure: Evaluation of GMTs
timeFrame: At Year 10
measure: Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines
timeFrame: At Year 6
measure: GMRs Calculated to Pre Booster Baselines
timeFrame: At Year 7
measure: GMRs Calculated to Pre Booster Baselines
timeFrame: At Year 8
measure: GMRs Calculated to Pre Booster Baselines
timeFrame: At Year 9
measure: GMRs Calculated to Pre Booster Baselines
timeFrame: At Year 10
measure: GMRs Calculated to Post Booster Baselines
timeFrame: At Year 6
measure: GMRs Calculated to Post Booster Baselines
timeFrame: At Year 7
measure: GMRs Calculated to Post Booster Baselines
timeFrame: At Year 8
measure: GMRs Calculated to Post Booster Baselines
timeFrame: At Year 9
measure: GMRs Calculated to Post Booster Baselines
timeFrame: At Year 10
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
timeFrame: At Year 6
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
timeFrame: At Year 7
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
timeFrame: At Year 8
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
timeFrame: At Year 9
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
timeFrame: At Year 10
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
timeFrame: At Year 6
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
timeFrame: At Year 7
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
timeFrame: At Year 8
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
timeFrame: At Year 9
measure: Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
timeFrame: At Year 10
measure: Evaluation of GMTs in the Age Group of 15-49 Years
timeFrame: At Year 6
measure: Evaluation of GMTs in the Age Group of 15-49 Years
timeFrame: At Year 7
measure: Evaluation of GMTs in the Age Group of 15-49 Years
timeFrame: At Year 8
measure: Evaluation of GMTs in the Age Group of 15-49 Years
timeFrame: At Year 9
measure: Evaluation of GMTs in the Age Group of 15-49 Years
timeFrame: At Year 10
measure: Evaluation of GMTs in the Age Group of ≥ 50 Years
timeFrame: At Year 6
measure: Evaluation of GMTs in the Age Group of ≥ 50 Years
timeFrame: At Year 7
measure: Evaluation of GMTs in the Age Group of ≥ 50 Years
timeFrame: At Year 8
measure: Evaluation of GMTs in the Age Group of ≥ 50 Years
timeFrame: At Year 9
measure: Evaluation of GMTs in the Age Group of ≥ 50 Years
timeFrame: At Year 10
measure: Evaluation of GMTs in the Age Group of ≥ 60 Years
timeFrame: At Year 6
measure: Evaluation of GMTs in the Age Group of ≥ 60 Years
timeFrame: At Year 7
measure: Evaluation of GMTs in the Age Group of ≥ 60 Years
timeFrame: At Year 8
measure: Evaluation of GMTs in the Age Group of ≥ 60 Years
timeFrame: At Year 9
measure: Evaluation of GMTs in the Age Group of ≥ 60 Years
timeFrame: At Year 10
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
timeFrame: At Year 6
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
timeFrame: At Year 7
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
timeFrame: At Year 8
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
timeFrame: At Year 9
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
timeFrame: At Year 10
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
timeFrame: At Year 6
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
timeFrame: At Year 7
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
timeFrame: At Year 8
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
timeFrame: At Year 9
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
timeFrame: At Year 10
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
timeFrame: At Year 6
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
timeFrame: At Year 7
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
timeFrame: At Year 8
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
timeFrame: At Year 9
measure: GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
timeFrame: At Year 10
measure: GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
timeFrame: At Year 6
measure: GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
timeFrame: At Year 7
measure: GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
timeFrame: At Year 8
measure: GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
timeFrame: At Year 9
measure: GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
timeFrame: At Year 10
measure: GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
timeFrame: At Year 6
measure: GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
timeFrame: At Year 7
measure: GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
timeFrame: At Year 8
measure: GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
timeFrame: At Year 9
measure: GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
timeFrame: At Year 10
measure: GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
timeFrame: At Year 6
measure: GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
timeFrame: At Year 7
measure: GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
timeFrame: At Year 8
measure: GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
timeFrame: At Year 9
measure: GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
timeFrame: At Year 10
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Beran J, Lattanzi M, Xie F, Moraschini L, Galgani I. Second five-year follow-up after a booster vaccination against tick-borne encephalitis following different primary vaccination schedules demonstrates at least 10 years antibody persistence. Vaccine. 2019 Jul 26;37(32):4623-4629. doi: 10.1016/j.vaccine.2017.12.081. Epub 2018 Feb 1.