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 Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: TBE_R Group 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). |
Other: Blood draw
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)
|
Other: TBE_C Group 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. |
Other: Blood draw
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)
|
Other: TBE_AC Group 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. |
Other: Blood draw
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2 [At Year 6]
Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.
- Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 [At Year 7]
Antibody titers were measured by GSK NT assay.
- Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 [At Year 8]
Antibody titers were measured by GSK NT assay.
- Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 [At Year 9]
Antibody titers were measured by GSK NT assay.
- Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 [At Year 10]
Antibody titers were measured by GSK NT assay.
- Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 [At Year 6]
Antibody titers were measured by GSK NT assay.
- Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 [At Year 7]
Antibody titers were measured by GSK NT assay.
- Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 [At Year 8]
Antibody titers were measured by GSK NT assay.
- Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 [At Year 9]
Antibody titers were measured by GSK NT assay.
- Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 [At Year 10]
Antibody titers were measured by GSK NT assay.
- Evaluation of Geometric Mean Antibody Titers (GMTs) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | GSK Investigational Site | Hradec Kralove | Czechia | 50002 |
Sponsors and Collaborators
- GlaxoSmithKline
- Novartis Vaccines
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
- 205335
- 2011-003255-19
- V48P7E2
Study Results
Participant Flow
Recruitment Details | Subjects who completed V48P7E1 study having received primary vaccination according to rapid (R), conventional (C) or accelerated conventional (AC) schedule were included in the study. Since modified conventional (MC) had not been accepted by health authorities as primary vaccination schedule, this group from V48P7 was not enrolled in this study. |
---|---|
Pre-assignment Detail | 206 subjects were enrolled in the study but one subject was not assigned to any group. Therefore, the number of subjects started is 205. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Period Title: Overall Study | |||
STARTED | 48 | 51 | 106 |
COMPLETED | 43 | 49 | 99 |
NOT COMPLETED | 5 | 2 | 7 |
Baseline Characteristics
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group | Total |
---|---|---|---|---|
Arm/Group Description | 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). | 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. | 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. | Total of all reporting groups |
Overall Participants | 48 | 51 | 106 | 205 |
Age (Years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [Years] |
42.7
(15.25)
|
41.8
(14.34)
|
42.4
(14.35)
|
42.3
(14.49)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
24
50%
|
32
62.7%
|
55
51.9%
|
111
54.1%
|
Male |
24
50%
|
19
37.3%
|
51
48.1%
|
94
45.9%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
White |
48
100%
|
51
100%
|
106
100%
|
205
100%
|
Outcome Measures
Title | Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2 |
---|---|
Description | Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Number (95% Confidence Interval) [Percentage of subjects] |
95.83
|
100.0
|
97.17
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 |
---|---|
Description | Antibody titers were measured by GSK NT assay. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Number (95% Confidence Interval) [Percentage of subjects] |
93.75
|
100.0
|
95.28
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 |
---|---|
Description | Antibody titers were measured by GSK NT assay. |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Number (95% Confidence Interval) [Percentage of subjects] |
89.58
|
98.04
|
93.40
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 |
---|---|
Description | Antibody titers were measured by GSK NT assay. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Number (95% Confidence Interval) [Percentage of subjects] |
89.58
|
94.12
|
92.45
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 |
---|---|
Description | Antibody titers were measured by GSK NT assay. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Number (95% Confidence Interval) [Percentage of subjects] |
89.58
|
96.08
|
93.40
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 |
---|---|
Description | Antibody titers were measured by GSK NT assay. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Number (95% Confidence Interval) [Percentage of subjects] |
95.83
|
100.0
|
97.17
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 |
---|---|
Description | Antibody titers were measured by GSK NT assay. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Number (95% Confidence Interval) [Percentage of subjects] |
93.75
|
100.0
|
95.28
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 |
---|---|
Description | Antibody titers were measured by GSK NT assay. |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Number (95% Confidence Interval) [Percentage of subjects] |
89.58
|
98.04
|
92.45
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 |
---|---|
Description | Antibody titers were measured by GSK NT assay. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Number (95% Confidence Interval) [Percentage of subjects] |
89.58
|
94.12
|
92.45
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 |
---|---|
Description | Antibody titers were measured by GSK NT assay. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Number (95% Confidence Interval) [Percentage of subjects] |
89.58
|
94.12
|
93.40
|
Title | Evaluation of Geometric Mean Antibody Titers (GMTs) |
---|---|
Description | 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. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Baseline GMT pre booster |
76
|
228
|
228
|
Baseline GMT post booster |
467
|
1135
|
985
|
GMT Year 6 |
292
|
293
|
221
|
Title | Evaluation of GMTs |
---|---|
Description | 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. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Baseline GMT pre booster |
76
|
228
|
228
|
Baseline GMT post booster |
467
|
1135
|
985
|
GMT Year 7 |
295
|
343
|
254
|
Title | Evaluation of GMTs |
---|---|
Description | 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. |
Time Frame | At year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Baseline GMT pre booster |
76
|
228
|
228
|
Baseline GMT post booster |
467
|
1135
|
985
|
GMT Year 8 |
134
|
211
|
155
|
Title | Evaluation of GMTs |
---|---|
Description | 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. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Baseline GMT pre booster |
76
|
228
|
228
|
Baseline GMT post booster |
467
|
1135
|
985
|
GMT Year 9 |
211
|
214
|
194
|
Title | Evaluation of GMTs |
---|---|
Description | 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. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 106 |
Baseline GMT pre booster |
76
|
228
|
228
|
Baseline GMT post booster |
467
|
1135
|
985
|
GMT Year 10 |
166
|
245
|
180
|
Title | Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines |
---|---|
Description | 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). |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 9 | 51 | 104 |
Geometric Mean (95% Confidence Interval) [Ratios] |
6.73
|
1.28
|
0.99
|
Title | GMRs Calculated to Pre Booster Baselines |
---|---|
Description | 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). |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 9 | 51 | 104 |
Geometric Mean (95% Confidence Interval) [Ratios] |
3.85
|
1.51
|
1.13
|
Title | GMRs Calculated to Pre Booster Baselines |
---|---|
Description | 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). |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 9 | 51 | 104 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.67
|
0.93
|
0.69
|
Title | GMRs Calculated to Pre Booster Baselines |
---|---|
Description | 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). |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 9 | 51 | 104 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.08
|
0.94
|
0.85
|
Title | GMRs Calculated to Pre Booster Baselines |
---|---|
Description | 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). |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 9 | 51 | 104 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.76
|
1.08
|
0.8
|
Title | GMRs Calculated to Post Booster Baselines |
---|---|
Description | 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. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 105 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.63
|
0.26
|
0.22
|
Title | GMRs Calculated to Post Booster Baselines |
---|---|
Description | 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. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 105 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.63
|
0.3
|
0.25
|
Title | GMRs Calculated to Post Booster Baselines |
---|---|
Description | 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. |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 105 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.29
|
0.19
|
0.16
|
Title | GMRs Calculated to Post Booster Baselines |
---|---|
Description | 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. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 105 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.45
|
0.19
|
0.2
|
Title | GMRs Calculated to Post Booster Baselines |
---|---|
Description | 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. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 48 | 51 | 105 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.36
|
0.22
|
0.18
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups |
---|---|
Description | Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
15-49 years: Antibody Titers ≥ 2 |
94.29
|
100.0
|
96.30
|
≥ 50 years: Antibody Titers ≥ 2 |
100.0
|
100.0
|
100.0
|
≥ 60 years: Antibody Titers ≥ 2 |
100.0
|
100.0
|
100.0
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups |
---|---|
Description | Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
15-49 years: Antibody Titers ≥ 2 |
91.43
|
100.0
|
93.83
|
≥ 50 years: Antibody Titers ≥ 2 |
100.0
|
100.0
|
100.0
|
≥ 60 years: Antibody Titers ≥ 2 |
100.0
|
100.0
|
100.0
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups |
---|---|
Description | Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years. |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
15-49 years: Antibody Titers ≥ 2 |
88.57
|
97.44
|
92.59
|
≥ 50 years: Antibody Titers ≥ 2 |
92.31
|
100.0
|
96.00
|
≥ 60 years: Antibody Titers ≥ 2 |
100.0
|
100.0
|
100.0
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups |
---|---|
Description | Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
15-49 years: Antibody Titers ≥ 2 |
88.57
|
92.31
|
91.36
|
≥ 50 years: Antibody Titers ≥ 2 |
92.31
|
100.0
|
96.00
|
≥ 60 years: Antibody Titers ≥ 2 |
100.0
|
100.0
|
100.0
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups |
---|---|
Description | Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
15-49 years: Antibody Titers ≥ 2 |
88.57
|
94.87
|
92.59
|
≥ 50 years: Antibody Titers ≥ 2 |
92.31
|
100.0
|
96.00
|
≥ 60 years: Antibody Titers ≥ 2 |
100.0
|
100.0
|
100.0
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups |
---|---|
Description | Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
15-49 years: Antibody Titers ≥ 10 |
94.29
|
100.0
|
96.30
|
≥ 50 years: Antibody Titers ≥ 10 |
100.0
|
100.0
|
100.0
|
≥ 60 years: Antibody Titers ≥ 10 |
100.0
|
100.0
|
100.0
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups |
---|---|
Description | Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
15-49 years: Antibody Titers ≥ 10 |
91.43
|
100.0
|
93.83
|
≥ 50 years: Antibody Titers ≥ 10 |
100.0
|
100.0
|
100.0
|
≥ 60 years: Antibody Titers ≥ 10 |
100.0
|
100.0
|
100.0
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups |
---|---|
Description | Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years. |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
15-49 years: Antibody Titers ≥ 10 |
88.57
|
97.44
|
91.36
|
≥ 50 years: Antibody Titers ≥ 10 |
92.31
|
100.0
|
96.00
|
≥ 60 years: Antibody Titers ≥ 10 |
100.0
|
100.0
|
100.0
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups |
---|---|
Description | Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
15-49 years: Antibody Titers ≥ 10 |
88.57
|
92.31
|
91.36
|
≥ 50 years: Antibody Titers ≥ 10 |
92.31
|
100.0
|
96.00
|
≥ 60 years: Antibody Titers ≥ 10 |
100.0
|
100.0
|
100.0
|
Title | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups |
---|---|
Description | Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
15-49 years: Antibody Titers ≥ 10 |
88.57
|
94.87
|
92.59
|
≥ 50 years: Antibody Titers ≥ 10 |
92.31
|
91.67
|
96.00
|
≥ 60 years: Antibody Titers ≥ 10 |
100.0
|
66.67
|
100.0
|
Title | Evaluation of GMTs in the Age Group of 15-49 Years |
---|---|
Description | 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. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
Baseline GMT pre booster |
76
|
253
|
263
|
Baseline GMT post booster |
638
|
1299
|
1008
|
GMT Year 6 |
332
|
341
|
235
|
Title | Evaluation of GMTs in the Age Group of 15-49 Years |
---|---|
Description | 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. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
Baseline GMT pre booster |
76
|
253
|
263
|
Baseline GMT post booster |
638
|
1299
|
1008
|
GMT Year 7 |
304
|
384
|
250
|
Title | Evaluation of GMTs in the Age Group of 15-49 Years |
---|---|
Description | 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. |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
Baseline GMT pre booster |
76
|
253
|
263
|
Baseline GMT post booster |
638
|
1299
|
1008
|
GMT Year 8 |
151
|
219
|
160
|
Title | Evaluation of GMTs in the Age Group of 15-49 Years |
---|---|
Description | 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. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
Baseline GMT pre booster |
76
|
253
|
263
|
Baseline GMT post booster |
638
|
1299
|
1008
|
GMT Year 9 |
218
|
211
|
191
|
Title | Evaluation of GMTs in the Age Group of 15-49 Years |
---|---|
Description | 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. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 81 |
Baseline GMT pre booster |
76
|
253
|
263
|
Baseline GMT post booster |
638
|
1299
|
1008
|
GMT Year 10 |
188
|
266
|
200
|
Title | Evaluation of GMTs in the Age Group of ≥ 50 Years |
---|---|
Description | 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. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 13 | 12 | 25 |
Baseline GMT pre booster |
163
|
145
|
|
Baseline GMT post booster |
201
|
733
|
914
|
GMT Year 6 |
207
|
178
|
183
|
Title | Evaluation of GMTs in the Age Group of ≥ 50 Years |
---|---|
Description | 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. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 13 | 12 | 25 |
Baseline GMT pre booster |
163
|
145
|
|
Baseline GMT post booster |
201
|
733
|
914
|
GMT Year 7 |
272
|
237
|
270
|
Title | Evaluation of GMTs in the Age Group of ≥ 50 Years |
---|---|
Description | 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. |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 13 | 12 | 25 |
Baseline GMT pre booster |
163
|
145
|
|
Baseline GMT post booster |
201
|
733
|
914
|
GMT Year 8 |
98
|
189
|
142
|
Title | Evaluation of GMTs in the Age Group of ≥ 50 Years |
---|---|
Description | 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. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 13 | 12 | 25 |
Baseline GMT pre booster |
163
|
145
|
|
Baseline GMT post booster |
201
|
733
|
914
|
GMT Year 9 |
193
|
224
|
202
|
Title | Evaluation of GMTs in the Age Group of ≥ 50 Years |
---|---|
Description | 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. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 13 | 12 | 25 |
Baseline GMT pre booster |
163
|
145
|
|
Baseline GMT post booster |
201
|
733
|
914
|
GMT Year 10 |
119
|
189
|
129
|
Title | Evaluation of GMTs in the Age Group of ≥ 60 Years |
---|---|
Description | 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. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 4 | 3 | 7 |
Baseline GMT pre booster |
64
|
69
|
|
Baseline GMT post booster |
173
|
573
|
498
|
GMT Year 6 |
189
|
96
|
76
|
Title | Evaluation of GMTs in the Age Group of ≥ 60 Years |
---|---|
Description | 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. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 4 | 3 | 7 |
Baseline GMT pre booster |
64
|
69
|
|
Baseline GMT post booster |
173
|
573
|
498
|
GMT Year 7 |
133
|
120
|
105
|
Title | Evaluation of GMTs in the Age Group of ≥ 60 Years |
---|---|
Description | 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. |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 4 | 3 | 7 |
Baseline GMT pre booster |
64
|
69
|
|
Baseline GMT post booster |
173
|
573
|
498
|
GMT Year 8 |
128
|
81
|
71
|
Title | Evaluation of GMTs in the Age Group of ≥ 60 Years |
---|---|
Description | 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. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 4 | 3 | 7 |
Baseline GMT pre booster |
64
|
69
|
|
Baseline GMT post booster |
173
|
573
|
498
|
GMT Year 9 |
224
|
67
|
128
|
Title | Evaluation of GMTs in the Age Group of ≥ 60 Years |
---|---|
Description | 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. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 4 | 3 | 7 |
Baseline GMT pre booster |
64
|
69
|
|
Baseline GMT post booster |
173
|
573
|
498
|
GMT Year 10 |
181
|
57
|
72
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years |
---|---|
Description | 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). |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 9 | 39 | 79 |
Geometric Mean (95% Confidence Interval) [Ratios] |
6.73
|
1.35
|
0.92
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years |
---|---|
Description | 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). |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 9 | 39 | 79 |
Geometric Mean (95% Confidence Interval) [Ratios] |
3.85
|
1.52
|
0.96
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years |
---|---|
Description | 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). |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 9 | 39 | 79 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.67
|
0.87
|
0.62
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years |
---|---|
Description | 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). |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 9 | 39 | 79 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.08
|
0.84
|
0.73
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years |
---|---|
Description | 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). |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 9 | 39 | 79 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.76
|
1.05
|
0.78
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years |
---|---|
Description | 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). |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 0 | 12 | 25 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.09
|
1.27
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years |
---|---|
Description | 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). |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 0 | 12 | 25 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.45
|
1.87
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years |
---|---|
Description | 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). |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 0 | 12 | 25 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.16
|
0.98
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years |
---|---|
Description | 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). |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 0 | 12 | 25 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.37
|
1.39
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years |
---|---|
Description | 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). |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 0 | 12 | 25 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.16
|
0.89
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years |
---|---|
Description | 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). |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 0 | 3 | 7 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.5
|
1.1
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years |
---|---|
Description | 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). |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 0 | 3 | 7 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.88
|
1.52
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years |
---|---|
Description | 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). |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 0 | 3 | 7 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.27
|
1.03
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years |
---|---|
Description | 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). |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 0 | 3 | 7 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.05
|
1.85
|
Title | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years |
---|---|
Description | 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). |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 0 | 3 | 7 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.89
|
1.04
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years |
---|---|
Description | 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. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 80 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.52
|
0.26
|
0.23
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years |
---|---|
Description | 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. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 80 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.48
|
0.3
|
0.24
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years |
---|---|
Description | 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. |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 80 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.24
|
0.17
|
0.16
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years |
---|---|
Description | 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. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 80 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.34
|
0.16
|
0.19
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years |
---|---|
Description | 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. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 35 | 39 | 80 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.29
|
0.2
|
0.2
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years |
---|---|
Description | 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. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 13 | 12 | 25 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.03
|
0.24
|
0.2
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years |
---|---|
Description | 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. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 13 | 12 | 25 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.36
|
0.32
|
0.3
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years |
---|---|
Description | 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. |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 13 | 12 | 25 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.49
|
0.26
|
0.16
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years |
---|---|
Description | 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. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 13 | 12 | 25 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.96
|
0.31
|
0.22
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years |
---|---|
Description | 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. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 13 | 12 | 25 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.59
|
0.26
|
0.14
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years |
---|---|
Description | 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. |
Time Frame | At Year 6 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 4 | 3 | 7 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.09
|
0.17
|
0.15
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years |
---|---|
Description | 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. |
Time Frame | At Year 7 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 4 | 3 | 7 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.77
|
0.21
|
0.21
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years |
---|---|
Description | 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. |
Time Frame | At Year 8 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 4 | 3 | 7 |
Geometric Mean (95% Confidence Interval) [Ratios] |
0.74
|
0.14
|
0.14
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years |
---|---|
Description | 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. |
Time Frame | At Year 9 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 4 | 3 | 7 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.29
|
0.12
|
0.26
|
Title | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years |
---|---|
Description | 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. |
Time Frame | At Year 10 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine. |
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group |
---|---|---|---|
Arm/Group Description | 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). | 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. | 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. |
Measure Participants | 4 | 3 | 7 |
Geometric Mean (95% Confidence Interval) [Ratios] |
1.05
|
0.1
|
0.14
|
Adverse Events
Time Frame | ||||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | The study was intended to evaluate the persistence of antibody response up to 10 years after booster vaccine administration. Safety profile of the vaccine was not evaluated as per study protocol. Hence, there are no safety results as per planned analysis. | |||||
Arm/Group Title | TBE_R Group | TBE_C Group | TBE_AC Group | |||
Arm/Group Description | 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). | 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. | 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. | |||
All Cause Mortality |
||||||
TBE_R Group | TBE_C Group | TBE_AC Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Serious Adverse Events |
||||||
TBE_R Group | TBE_C Group | TBE_AC Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Other (Not Including Serious) Adverse Events |
||||||
TBE_R Group | TBE_C Group | TBE_AC Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title | GSK Response Center |
---|---|
Organization | GlaxoSmithKline |
Phone | 866-435-7343 |
- 205335
- 2011-003255-19
- V48P7E2