Last updated: 11/15/2021 10:10:06
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
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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 description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Percentage of subjects with detectable TBE antibody titers greater than or equal to (≥) 2
Timeframe: At Year 6
Percentage of subjects with detectable TBE antibody titers ≥ 2
Timeframe: At Year 7
Percentage of subjects with detectable TBE antibody titers ≥ 2
Timeframe: At Year 8
Percentage of subjects with detectable TBE antibody titers ≥ 2
Timeframe: At Year 9
Percentage of subjects with detectable TBE antibody titers ≥ 2
Timeframe: At Year 10
Percentage of subjects with detectable TBE antibody titers ≥ 10
Timeframe: At Year 6
Percentage of subjects with detectable TBE antibody titers ≥ 10
Timeframe: At Year 7
Percentage of subjects with detectable TBE antibody titers ≥ 10
Timeframe: At Year 8
Percentage of subjects with detectable TBE antibody titers ≥ 10
Timeframe: At Year 9
Percentage of subjects with detectable TBE antibody titers ≥ 10
Timeframe: At Year 10
Evaluation of Geometric Mean Antibody Titers (GMTs)
Timeframe: At Year 6
Evaluation of GMTs
Timeframe: At Year 7
Evaluation of GMTs
Timeframe: At year 8
Evaluation of GMTs
Timeframe: At Year 9
Evaluation of GMTs
Timeframe: At Year 10
Geometric Mean Ratios (GMRs) calculated to pre booster baselines
Timeframe: At Year 6
GMRs calculated to pre booster baselines
Timeframe: At Year 7
GMRs calculated to pre booster baselines
Timeframe: At Year 8
GMRs calculated to pre booster baselines
Timeframe: At Year 9
GMRs calculated to pre booster baselines
Timeframe: At Year 10
GMRs calculated to post booster baselines
Timeframe: At Year 6
GMRs calculated to post booster baselines
Timeframe: At Year 7
GMRs calculated to post booster baselines
Timeframe: At Year 8
GMRs calculated to post booster baselines
Timeframe: At Year 9
GMRs calculated to post booster baselines
Timeframe: At Year 10
Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups
Timeframe: At Year 6
Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups
Timeframe: At Year 7
Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups
Timeframe: At Year 8
Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups
Timeframe: At Year 9
Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups
Timeframe: At Year 10
Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups
Timeframe: At Year 6
Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups
Timeframe: At Year 7
Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups
Timeframe: At Year 8
Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups
Timeframe: At Year 9
Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups
Timeframe: At Year 10
Evaluation of GMTs in the age group of 15-49 years
Timeframe: At Year 6
Evaluation of GMTs in the age group of 15-49 years
Timeframe: At Year 7
Evaluation of GMTs in the age group of 15-49 years
Timeframe: At Year 8
Evaluation of GMTs in the age group of 15-49 years
Timeframe: At Year 9
Evaluation of GMTs in the age group of 15-49 years
Timeframe: At Year 10
Evaluation of GMTs in the age group of ≥ 50 years
Timeframe: At Year 6
Evaluation of GMTs in the age group of ≥ 50 years
Timeframe: At Year 7
Evaluation of GMTs in the age group of ≥ 50 years
Timeframe: At Year 8
Evaluation of GMTs in the age group of ≥ 50 years
Timeframe: At Year 9
Evaluation of GMTs in the age group of ≥ 50 years
Timeframe: At Year 10
Evaluation of GMTs in the age group of ≥ 60 years
Timeframe: At Year 6
Evaluation of GMTs in the age group of ≥ 60 years
Timeframe: At Year 7
Evaluation of GMTs in the age group of ≥ 60 years
Timeframe: At Year 8
Evaluation of GMTs in the age group of ≥ 60 years
Timeframe: At Year 9
Evaluation of GMTs in the age group of ≥ 60 years
Timeframe: At Year 10
GMRs calculated to pre booster baselines in the age group of 15-49 years
Timeframe: At Year 6
GMRs calculated to pre booster baselines in the age group of 15-49 years
Timeframe: At Year 7
GMRs calculated to pre booster baselines in the age group of 15-49 years
Timeframe: At Year 8
GMRs calculated to pre booster baselines in the age group of 15-49 years
Timeframe: At Year 9
GMRs calculated to pre booster baselines in the age group of 15-49 years
Timeframe: At Year 10
GMRs calculated to pre booster baselines in the age group of ≥ 50 years
Timeframe: At Year 6
GMRs calculated to pre booster baselines in the age group of ≥ 50 years
Timeframe: At Year 7
GMRs calculated to pre booster baselines in the age group of ≥ 50 years
Timeframe: At Year 8
GMRs calculated to pre booster baselines in the age group of ≥ 50 years
Timeframe: At Year 9
GMRs calculated to pre booster baselines in the age group of ≥ 50 years
Timeframe: At Year 10
GMRs calculated to pre booster baselines in the age group of ≥ 60 years
Timeframe: At Year 6
GMRs calculated to pre booster baselines in the age group of ≥ 60 years
Timeframe: At Year 7
GMRs calculated to pre booster baselines in the age group of ≥ 60 years
Timeframe: At Year 8
GMRs calculated to pre booster baselines in the age group of ≥ 60 years
Timeframe: At Year 9
GMRs calculated to pre booster baselines in the age group of ≥ 60 years
Timeframe: At Year 10
GMRs calculated to post booster baselines in the age group of 15-49 years
Timeframe: At Year 6
GMRs calculated to post booster baselines in the age group of 15-49 years
Timeframe: At Year 7
GMRs calculated to post booster baselines in the age group of 15-49 years
Timeframe: At Year 8
GMRs calculated to post booster baselines in the age group of 15-49 years
Timeframe: At Year 9
GMRs calculated to post booster baselines in the age group of 15-49 years
Timeframe: At Year 10
GMRs calculated to post booster baselines in the age group of ≥ 50 years
Timeframe: At Year 6
GMRs calculated to post booster baselines in the age group of ≥ 50 years
Timeframe: At Year 7
GMRs calculated to post booster baselines in the age group of ≥ 50 years
Timeframe: At Year 8
GMRs calculated to post booster baselines in the age group of ≥ 50 years
Timeframe: At Year 9
GMRs calculated to post booster baselines in the age group of ≥ 50 years
Timeframe: At Year 10
GMRs calculated to post booster baselines in the age group of ≥ 60 years
Timeframe: At Year 6
GMRs calculated to post booster baselines in the age group of ≥ 60 years
Timeframe: At Year 7
GMRs calculated to post booster baselines in the age group of ≥ 60 years
Timeframe: At Year 8
GMRs calculated to post booster baselines in the age group of ≥ 60 years
Timeframe: At Year 9
GMRs calculated to post booster baselines in the age group of ≥ 60 years
Timeframe: At Year 10
Secondary outcomes:
Not applicable
Interventions:
Other: Blood draw
Enrollment:
206
Observational study model:
Not applicable
Primary completion date:
2016-30-09
Time perspective:
Not applicable
Clinical publications:
Beran J et al. (2018) 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. doi: 10.1016 [Epub ahead of print].
Medical condition
Tick borne encephalitis, Virus Diseases
Product
GSK3536859A
Collaborators
Novartis Vaccines
Study date(s)
March 2012 to September 2016
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Subjects who have completed prior study - V48P7E1.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2016-30-09
Actual study completion date
2016-30-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
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