Tick Borne EncephalitisPhase 4NCT01562444
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
A Phase 4 study testing Blood draw in people with Tick Borne Encephalitis and Virus Diseases, run by GlaxoSmithKline at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tick Borne Encephalitis, Virus Diseases
- What is being tested?
- Blood draw
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteCzechia
- Study dates
- 8 Mar 2012to 30 Sep 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who have completed prior study - V48P7E1.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Tick Borne Encephalitis, Virus Diseases
- Being tested
- Blood draw
- Keywords
- Long term immunogenicity study
- Medical subject headings
- Encephalitis, Tick-Borne, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)
| Study group | Role | What they receive |
|---|---|---|
| TBE_R Group | Other | Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from >6 years up to >10 years after booster vaccination). Receives: Other: Blood draw |
| TBE_C Group | Other | Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination. Receives: Other: Blood draw |
| TBE_AC Group | Other | Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination. Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2
Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.
Measured: At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Measured: At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Measured: At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Measured: At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Measured: At Year 10
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Measured: At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Measured: At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Measured: At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Measured: At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Measured: At Year 10
Evaluation of Geometric Mean Antibody Titers (GMTs)
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate Geometric Mean Ratios (GMRs). Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 6
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 7
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At year 8
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 9
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 10
Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 6
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 7
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 8
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 9
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 10
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 6
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 7
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 8
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 9
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 10
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Measured: At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Measured: At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Measured: At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Measured: At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Measured: At Year 10
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Measured: At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Measured: At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Measured: At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Measured: At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Measured: At Year 10
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 6
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 7
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 8
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 9
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 10
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 6
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 7
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 8
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 9
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 10
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 6
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 7
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 8
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 9
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 10
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 6
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 7
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 8
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 9
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 10
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 6
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 7
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 8
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 9
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 10
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 6
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 7
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 8
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 9
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Measured: At Year 10
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 6
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 7
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 8
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 9
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 10
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 6
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 7
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 8
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 9
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 10
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 6
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 7
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 8
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 9
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Measured: At Year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study start8 Mar 2012
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tick Borne EncephalitisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562444
- Sponsor's protocol ID
- 205335
- Other IDs
- 2011-003255-19, V48P7E2
- Status last verified
- Aug 2021
- First submitted
- 13 Mar 2012
- Last updated
- 12 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29397225
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01562444
- Acronym / sponsor ID
- 205335
- Conditions
- Tick Borne Encephalitis, Virus Diseases
- Keywords
- Long term immunogenicity study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- 8 Mar 2012 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Posted 31 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TBE_R Group | Other | Other: Blood drawSubjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from >6 years up to >10 years after booster vaccination). |
| TBE_C Group | Other | Other: Blood drawSubjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination. |
| TBE_AC Group | Other | Other: Blood drawSubjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who have completed prior study - V48P7E1.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawAnnual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22) | Other | TBE_AC Group, TBE_C Group, TBE_R Group |
Primary outcome
Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2
Time frame: At Year 6
Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Time frame: At Year 7
Antibody titers were measured by GSK NT assay.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Time frame: At Year 8
Antibody titers were measured by GSK NT assay.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Time frame: At Year 9
Antibody titers were measured by GSK NT assay.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Time frame: At Year 10
Antibody titers were measured by GSK NT assay.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Time frame: At Year 6
Antibody titers were measured by GSK NT assay.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Time frame: At Year 7
Antibody titers were measured by GSK NT assay.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Time frame: At Year 8
Antibody titers were measured by GSK NT assay.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Time frame: At Year 9
Antibody titers were measured by GSK NT assay.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Time frame: At Year 10
Antibody titers were measured by GSK NT assay.
Evaluation of Geometric Mean Antibody Titers (GMTs)
Time frame: At Year 6
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate Geometric Mean Ratios (GMRs). Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs
Time frame: At Year 7
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs
Time frame: At year 8
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs
Time frame: At Year 9
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs
Time frame: At Year 10
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines
Time frame: At Year 6
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines
Time frame: At Year 7
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines
Time frame: At Year 8
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines
Time frame: At Year 9
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines
Time frame: At Year 10
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Post Booster Baselines
Time frame: At Year 6
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines
Time frame: At Year 7
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines
Time frame: At Year 8
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines
Time frame: At Year 9
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines
Time frame: At Year 10
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Time frame: At Year 6
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Time frame: At Year 7
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Time frame: At Year 8
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Time frame: At Year 9
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Time frame: At Year 10
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Time frame: At Year 6
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Time frame: At Year 7
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Time frame: At Year 8
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Time frame: At Year 9
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Time frame: At Year 10
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Evaluation of GMTs in the Age Group of 15-49 Years
Time frame: At Year 6
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of 15-49 Years
Time frame: At Year 7
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of 15-49 Years
Time frame: At Year 8
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of 15-49 Years
Time frame: At Year 9
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of 15-49 Years
Time frame: At Year 10
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of ≥ 50 Years
Time frame: At Year 6
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of ≥ 50 Years
Time frame: At Year 7
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of ≥ 50 Years
Time frame: At Year 8
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of ≥ 50 Years
Time frame: At Year 9
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of ≥ 50 Years
Time frame: At Year 10
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of ≥ 60 Years
Time frame: At Year 6
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of ≥ 60 Years
Time frame: At Year 7
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of ≥ 60 Years
Time frame: At Year 8
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of ≥ 60 Years
Time frame: At Year 9
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Evaluation of GMTs in the Age Group of ≥ 60 Years
Time frame: At Year 10
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
Time frame: At Year 6
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
Time frame: At Year 7
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
Time frame: At Year 8
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
Time frame: At Year 9
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
Time frame: At Year 10
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
Time frame: At Year 6
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
Time frame: At Year 7
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
Time frame: At Year 8
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
Time frame: At Year 9
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
Time frame: At Year 10
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
Time frame: At Year 6
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
Time frame: At Year 7
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
Time frame: At Year 8
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
Time frame: At Year 9
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
Time frame: At Year 10
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
Time frame: At Year 6
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
Time frame: At Year 7
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
Time frame: At Year 8
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
Time frame: At Year 9
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
Time frame: At Year 10
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
Time frame: At Year 6
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
Time frame: At Year 7
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
Time frame: At Year 8
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
Time frame: At Year 9
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
Time frame: At Year 10
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
Time frame: At Year 6
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
Time frame: At Year 7
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
Time frame: At Year 8
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
Time frame: At Year 9
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
Time frame: At Year 10
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29397225Beran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood draw in people with Tick Borne Encephalitis and Virus Diseases, run by GlaxoSmithKline at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2 (time frame: At Year 6). The study lists 80 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01562444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.