Tick Borne Encephalitis, Virus Diseases
Conditions
Keywords
Long term immunogenicity study
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.
Interventions
OTHERBlood draw
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)
Sponsors
Novartis Vaccines
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 ≥ 10 | At Year 6 | 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. |
| 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 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. |
| 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 ≥ 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. |
| 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 ≥ 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 ≥ 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. |
| 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 ≥ 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 ≥ 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 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 ≥ 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 ≥ 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. |
Countries
Czechia
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 details
206 subjects were enrolled in the study but one subject was not assigned to any group. Therefore, the number of subjects started is 205.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 48 |
| 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. | 51 |
| 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. | 106 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not comply with blood draw schedule | 1 | 0 | 1 |
| Overall Study | Did not meet entry criteria | 2 | 0 | 3 |
| Overall Study | Protocol forbidden concomitant vaccine | 1 | 0 | 1 |
| Overall Study | Protocol forbidden medication | 1 | 0 | 0 |
| Overall Study | Unavailable serological results | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | TBE_R Group | TBE_C Group | TBE_AC Group | Total |
|---|---|---|---|---|
| Age, Continuous | 42.7 Years STANDARD_DEVIATION 15.25 | 41.8 Years STANDARD_DEVIATION 14.34 | 42.4 Years STANDARD_DEVIATION 14.35 | 42.3 Years STANDARD_DEVIATION 14.49 |
| Race/Ethnicity, Customized White | 48 Participants | 51 Participants | 106 Participants | 205 Participants |
| Sex: Female, Male Female | 24 Participants | 32 Participants | 55 Participants | 111 Participants |
| Sex: Female, Male Male | 24 Participants | 19 Participants | 51 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Evaluation of Geometric Mean Antibody Titers (GMTs)
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate Geometric Mean Ratios (GMRs). Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of Geometric Mean Antibody Titers (GMTs) | Baseline GMT post booster | 467 Titers |
| TBE_R Group | Evaluation of Geometric Mean Antibody Titers (GMTs) | Baseline GMT pre booster | 76 Titers |
| TBE_R Group | Evaluation of Geometric Mean Antibody Titers (GMTs) | GMT Year 6 | 292 Titers |
| TBE_C Group | Evaluation of Geometric Mean Antibody Titers (GMTs) | Baseline GMT post booster | 1135 Titers |
| TBE_C Group | Evaluation of Geometric Mean Antibody Titers (GMTs) | Baseline GMT pre booster | 228 Titers |
| TBE_C Group | Evaluation of Geometric Mean Antibody Titers (GMTs) | GMT Year 6 | 293 Titers |
| TBE_AC Group | Evaluation of Geometric Mean Antibody Titers (GMTs) | Baseline GMT pre booster | 228 Titers |
| TBE_AC Group | Evaluation of Geometric Mean Antibody Titers (GMTs) | GMT Year 6 | 221 Titers |
| TBE_AC Group | Evaluation of Geometric Mean Antibody Titers (GMTs) | Baseline GMT post booster | 985 Titers |
Primary
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs | Baseline GMT post booster | 467 Titers |
| TBE_R Group | Evaluation of GMTs | Baseline GMT pre booster | 76 Titers |
| TBE_R Group | Evaluation of GMTs | GMT Year 10 | 166 Titers |
| TBE_C Group | Evaluation of GMTs | Baseline GMT post booster | 1135 Titers |
| TBE_C Group | Evaluation of GMTs | Baseline GMT pre booster | 228 Titers |
| TBE_C Group | Evaluation of GMTs | GMT Year 10 | 245 Titers |
| TBE_AC Group | Evaluation of GMTs | Baseline GMT pre booster | 228 Titers |
| TBE_AC Group | Evaluation of GMTs | GMT Year 10 | 180 Titers |
| TBE_AC Group | Evaluation of GMTs | Baseline GMT post booster | 985 Titers |
Primary
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs | Baseline GMT post booster | 467 Titers |
| TBE_R Group | Evaluation of GMTs | Baseline GMT pre booster | 76 Titers |
| TBE_R Group | Evaluation of GMTs | GMT Year 9 | 211 Titers |
| TBE_C Group | Evaluation of GMTs | Baseline GMT post booster | 1135 Titers |
| TBE_C Group | Evaluation of GMTs | Baseline GMT pre booster | 228 Titers |
| TBE_C Group | Evaluation of GMTs | GMT Year 9 | 214 Titers |
| TBE_AC Group | Evaluation of GMTs | Baseline GMT pre booster | 228 Titers |
| TBE_AC Group | Evaluation of GMTs | GMT Year 9 | 194 Titers |
| TBE_AC Group | Evaluation of GMTs | Baseline GMT post booster | 985 Titers |
Primary
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At year 8
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs | Baseline GMT post booster | 467 Titers |
| TBE_R Group | Evaluation of GMTs | Baseline GMT pre booster | 76 Titers |
| TBE_R Group | Evaluation of GMTs | GMT Year 8 | 134 Titers |
| TBE_C Group | Evaluation of GMTs | Baseline GMT post booster | 1135 Titers |
| TBE_C Group | Evaluation of GMTs | Baseline GMT pre booster | 228 Titers |
| TBE_C Group | Evaluation of GMTs | GMT Year 8 | 211 Titers |
| TBE_AC Group | Evaluation of GMTs | Baseline GMT pre booster | 228 Titers |
| TBE_AC Group | Evaluation of GMTs | GMT Year 8 | 155 Titers |
| TBE_AC Group | Evaluation of GMTs | Baseline GMT post booster | 985 Titers |
Primary
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs | Baseline GMT post booster | 467 Titers |
| TBE_R Group | Evaluation of GMTs | Baseline GMT pre booster | 76 Titers |
| TBE_R Group | Evaluation of GMTs | GMT Year 7 | 295 Titers |
| TBE_C Group | Evaluation of GMTs | Baseline GMT post booster | 1135 Titers |
| TBE_C Group | Evaluation of GMTs | Baseline GMT pre booster | 228 Titers |
| TBE_C Group | Evaluation of GMTs | GMT Year 7 | 343 Titers |
| TBE_AC Group | Evaluation of GMTs | Baseline GMT pre booster | 228 Titers |
| TBE_AC Group | Evaluation of GMTs | GMT Year 7 | 254 Titers |
| TBE_AC Group | Evaluation of GMTs | Baseline GMT post booster | 985 Titers |
Primary
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 638 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 76 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 7 | 304 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 1299 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 253 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 7 | 384 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 263 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 7 | 250 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 1008 Titers |
Primary
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 638 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 76 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 10 | 188 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 1299 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 253 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 10 | 266 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 263 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 10 | 200 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 1008 Titers |
Primary
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 638 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 76 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 9 | 218 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 1299 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 253 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 9 | 211 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 263 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 9 | 191 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 1008 Titers |
Primary
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 8 | 151 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 638 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 76 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 8 | 219 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 253 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 1299 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 1008 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 263 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 8 | 160 Titers |
Primary
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 638 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 76 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 6 | 332 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 1299 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 253 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 6 | 341 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT pre booster | 263 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | GMT Year 6 | 235 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of 15-49 Years | Baseline GMT post booster | 1008 Titers |
Primary
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 6 | 207 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 201 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 6 | 178 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT pre booster | 163 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 733 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 6 | 183 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT pre booster | 145 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 914 Titers |
Primary
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 9 | 193 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 201 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 9 | 224 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT pre booster | 163 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 733 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 9 | 202 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT pre booster | 145 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 914 Titers |
Primary
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 7 | 272 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 201 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 7 | 237 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT pre booster | 163 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 733 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 7 | 270 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT pre booster | 145 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 914 Titers |
Primary
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 10 | 119 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 201 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 10 | 189 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT pre booster | 163 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 733 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 10 | 129 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT pre booster | 145 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 914 Titers |
Primary
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 8 | 98 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 201 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 8 | 189 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT pre booster | 163 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 733 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | GMT Year 8 | 142 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT pre booster | 145 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 50 Years | Baseline GMT post booster | 914 Titers |
Primary
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 7 | 133 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 173 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 573 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT pre booster | 64 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 7 | 120 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 498 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 7 | 105 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT pre booster | 69 Titers |
Primary
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 10 | 181 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 173 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 10 | 57 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT pre booster | 64 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 573 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 10 | 72 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT pre booster | 69 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 498 Titers |
Primary
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 9 | 224 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 173 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 9 | 67 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT pre booster | 64 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 573 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 9 | 128 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT pre booster | 69 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 498 Titers |
Primary
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 8 | 128 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 173 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 8 | 81 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT pre booster | 64 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 573 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 8 | 71 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT pre booster | 69 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 498 Titers |
Primary
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 6 | 189 Titers |
| TBE_R Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 173 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 6 | 96 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT pre booster | 64 Titers |
| TBE_C Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 573 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | GMT Year 6 | 76 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT pre booster | 69 Titers |
| TBE_AC Group | Evaluation of GMTs in the Age Group of ≥ 60 Years | Baseline GMT post booster | 498 Titers |
Primary
Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 6
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines | 6.73 Ratios |
| TBE_C Group | Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines | 1.28 Ratios |
| TBE_AC Group | Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines | 0.99 Ratios |
Primary
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines | 0.63 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines | 0.26 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines | 0.22 Ratios |
Primary
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines | 0.63 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines | 0.3 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines | 0.25 Ratios |
Primary
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines | 0.29 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines | 0.19 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines | 0.16 Ratios |
Primary
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines | 0.45 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines | 0.19 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines | 0.2 Ratios |
Primary
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines | 0.36 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines | 0.22 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines | 0.18 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.48 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.3 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.24 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.52 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.26 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.23 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.29 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.2 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.2 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.34 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.16 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.19 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.24 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.17 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.16 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 1.36 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.32 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.3 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 1.03 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.24 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.2 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.59 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.26 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.14 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.96 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.31 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.22 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.49 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.26 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.16 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 1.05 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.1 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.14 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 1.09 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.17 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.15 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.77 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.21 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.21 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.74 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.14 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.14 Ratios |
Primary
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 1.29 Ratios |
| TBE_C Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.12 Ratios |
| TBE_AC Group | GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.26 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 10
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Pre Booster Baselines | 0.76 Ratios |
| TBE_C Group | GMRs Calculated to Pre Booster Baselines | 1.08 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines | 0.8 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 7
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Pre Booster Baselines | 3.85 Ratios |
| TBE_C Group | GMRs Calculated to Pre Booster Baselines | 1.51 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines | 1.13 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 8
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Pre Booster Baselines | 0.67 Ratios |
| TBE_C Group | GMRs Calculated to Pre Booster Baselines | 0.93 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines | 0.69 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 9
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Pre Booster Baselines | 1.08 Ratios |
| TBE_C Group | GMRs Calculated to Pre Booster Baselines | 0.94 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines | 0.85 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 9
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 1.08 Ratios |
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 0.84 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 0.73 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 6
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 6.73 Ratios |
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 1.35 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 0.92 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 8
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 0.67 Ratios |
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 0.87 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 0.62 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 7
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 3.85 Ratios |
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 1.52 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 0.96 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 10
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_R Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 0.76 Ratios |
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 1.05 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 0.78 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 6
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | 1.09 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | 1.27 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 7
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | 1.45 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | 1.87 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 8
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | 1.16 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | 0.98 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 9
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | 1.37 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | 1.39 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 10
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | 1.16 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | 0.89 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 7
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | 1.88 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | 1.52 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 8
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | 1.27 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | 1.03 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 9
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | 1.05 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | 1.85 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 10
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | 0.89 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | 1.04 Ratios |
Primary
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 6
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| TBE_C Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | 1.5 Ratios |
| TBE_AC Group | GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | 1.1 Ratios |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Time frame: At Year 7
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 93.75 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 95.28 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Time frame: At Year 10
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 89.58 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 94.12 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 93.40 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Time frame: At Year 9
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 89.58 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 94.12 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 92.45 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Time frame: At Year 8
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 89.58 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 98.04 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 92.45 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Time frame: At Year 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 95.83 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 97.17 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 7
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 100.0 Number of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 91.43 Number of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Number of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 100.0 Number of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 100.0 Number of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Number of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 93.83 Number of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Number of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 100.0 Number of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 10
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 92.31 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 88.57 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 91.67 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 94.87 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 66.67 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 92.59 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 96.00 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 9
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 92.31 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 88.57 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 92.31 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 91.36 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 96.00 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 8
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 92.31 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 88.57 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 97.44 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 91.36 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 96.00 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 6
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 94.29 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | 15-49 years: Antibody Titers ≥ 10 | 96.30 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 60 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups | ≥ 50 years: Antibody Titers ≥ 10 | 100.0 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Time frame: At Year 7
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 93.75 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 95.28 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Time frame: At Year 10
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 89.58 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 96.08 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 93.40 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Time frame: At Year 9
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 89.58 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 94.12 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 92.45 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Time frame: At Year 8
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 89.58 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 98.04 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 93.40 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 10
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 92.31 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 88.57 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 94.87 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 92.59 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 96.00 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 9
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 92.31 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 88.57 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 92.31 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 91.36 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 96.00 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 6
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 94.29 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 96.30 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 7
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 91.43 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 93.83 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 8
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 92.31 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 88.57 Percentage of subjects |
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 97.44 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | 15-49 years: Antibody Titers ≥ 2 | 92.59 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 60 years: Antibody Titers ≥ 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups | ≥ 50 years: Antibody Titers ≥ 2 | 96.00 Percentage of subjects |
Primary
Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2
Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.
Time frame: At Year 6
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TBE_R Group | Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2 | 95.83 Percentage of subjects |
| TBE_C Group | Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2 | 100.0 Percentage of subjects |
| TBE_AC Group | Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2 | 97.17 Percentage of subjects |