A Phase 4 interventional study of Blood draw in Tick Borne Encephalitis and Virus Diseases, sponsored by GlaxoSmithKline. Completed at 1 site in Czechia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-12.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Prevention
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.
51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.
This study's enrollment of 206 is close to the median of 192 across 32 interventional studies indexed under Encephalitis, Tick-Borne.
Browse Encephalitis, Tick-Borne studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
Other: Blood draw
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
Other: Blood draw
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
Other: Blood draw
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)
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
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Time frame: At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Time frame: At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Time frame: At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Antibody titers were measured by GSK NT assay.
Time frame: At Year 10
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Time frame: At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Time frame: At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Time frame: At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Time frame: At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Antibody titers were measured by GSK NT assay.
Time frame: At Year 10
Evaluation of Geometric Mean Antibody Titers (GMTs)
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate Geometric Mean Ratios (GMRs). Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At year 8
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Evaluation of GMTs
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 6
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 7
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 8
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 9
GMRs Calculated to Pre Booster Baselines
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 10
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
GMRs Calculated to Post Booster Baselines
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 10
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Time frame: At Year 10
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Evaluation of GMTs in the Age Group of 15-49 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 6
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 7
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 8
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 9
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 10
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 6
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 7
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 8
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 9
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 10
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 6
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 7
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 8
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 9
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).
Time frame: At Year 10
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 6
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 7
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 8
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 9
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.
Time frame: At Year 10
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.
| Milestone | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Started | 48 | 51 | 106 |
| Completed | 43 | 49 | 99 |
| Not completed | 5 | 2 | 7 |
| Withdrew: Did not meet entry criteria | 2 | 0 | 3 |
| Withdrew: Did not comply with blood draw schedule | 1 | 0 | 1 |
| Withdrew: Unavailable serological results | 0 | 2 | 2 |
| Withdrew: Protocol forbidden concomitant vaccine | 1 | 0 | 1 |
| Withdrew: Protocol forbidden medication | 1 | 0 | 0 |
Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2 | 95.83 (85.75 to 99.49) | 100.0 (93.02 to 100.0) | 97.17 (91.95 to 99.41) |
Antibody titers were measured by GSK NT assay.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 93.75 (82.80 to 98.69) | 100.0 (93.02 to 100.0) | 95.28 (89.33 to 98.45) |
Antibody titers were measured by GSK NT assay.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 89.58 (77.34 to 96.53) | 98.04 (89.55 to 99.95) | 93.40 (86.87 to 97.30) |
Antibody titers were measured by GSK NT assay.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 89.58 (77.34 to 96.53) | 94.12 (83.76 to 98.77) | 92.45 (85.67 to 96.69) |
Antibody titers were measured by GSK NT assay.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 | 89.58 (77.34 to 96.53) | 96.08 (86.54 to 99.52) | 93.40 (86.87 to 97.30) |
Antibody titers were measured by GSK NT assay.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 95.83 (85.75 to 99.49) | 100.0 (93.02 to 100.0) | 97.17 (91.95 to 99.41) |
Antibody titers were measured by GSK NT assay.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 93.75 (82.80 to 98.69) | 100.0 (93.02 to 100.0) | 95.28 (89.33 to 98.45) |
Antibody titers were measured by GSK NT assay.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 89.58 (77.34 to 96.53) | 98.04 (89.55 to 99.95) | 92.45 (85.67 to 96.69) |
Antibody titers were measured by GSK NT assay.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 89.58 (77.34 to 96.53) | 94.12 (83.76 to 98.77) | 92.45 (85.67 to 96.69) |
Antibody titers were measured by GSK NT assay.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 | 89.58 (77.34 to 96.53) | 94.12 (83.76 to 98.77) | 93.40 (86.87 to 97.30) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | 76 (28 to 208) | 228 (149 to 348) | 228 (170 to 307) |
| Baseline GMT post booster | 467 (325 to 670) | 1135 (799 to 1611) | 985 (771 to 1257) |
| GMT Year 6 | 292 (184 to 463) | 293 (187 to 458) | 221 (162 to 302) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | 76 (28 to 208) | 228 (149 to 348) | 228 (170 to 307) |
| Baseline GMT post booster | 467 (325 to 670) | 1135 (799 to 1611) | 985 (771 to 1257) |
| GMT Year 7 | 295 (180 to 484) | 343 (212 to 555) | 254 (182 to 355) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | 76 (28 to 208) | 228 (149 to 348) | 228 (170 to 307) |
| Baseline GMT post booster | 467 (325 to 670) | 1135 (799 to 1611) | 985 (771 to 1257) |
| GMT Year 8 | 134 (79 to 227) | 211 (127 to 352) | 155 (109 to 221) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | 76 (28 to 208) | 228 (149 to 348) | 228 (170 to 307) |
| Baseline GMT post booster | 467 (325 to 670) | 1135 (799 to 1611) | 985 (771 to 1257) |
| GMT Year 9 | 211 (119 to 375) | 214 (122 to 374) | 194 (131 to 285) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | 76 (28 to 208) | 228 (149 to 348) | 228 (170 to 307) |
| Baseline GMT post booster | 467 (325 to 670) | 1135 (799 to 1611) | 985 (771 to 1257) |
| GMT Year 10 | 166 (94 to 295) | 245 (140 to 428) | 180 (122 to 265) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines | 6.73 (3.23 to 14.02) | 1.28 (0.94 to 1.75) | 0.99 (0.8 to 1.23) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines | 3.85 (1.48 to 10) | 1.51 (1.01 to 2.25) | 1.13 (0.85 to 1.5) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines | 0.67 (0.23 to 1.91) | 0.93 (0.6 to 1.44) | 0.69 (0.51 to 0.95) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines | 1.08 (0.33 to 3.53) | 0.94 (0.57 to 1.54) | 0.85 (0.6 to 1.21) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines | 0.76 (0.26 to 2.24) | 1.08 (0.68 to 1.69) | 0.8 (0.59 to 1.1) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines | 0.63 (0.46 to 0.86) | 0.26 (0.19 to 0.35) | 0.22 (0.18 to 0.28) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines | 0.63 (0.41 to 0.96) | 0.3 (0.2 to 0.46) | 0.25 (0.19 to 0.34) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines | 0.29 (0.18 to 0.47) | 0.19 (0.12 to 0.3) | 0.16 (0.11 to 0.22) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines | 0.45 (0.27 to 0.77) | 0.19 (0.11 to 0.32) | 0.2 (0.14 to 0.28) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines | 0.36 (0.21 to 0.6) | 0.22 (0.13 to 0.36) | 0.18 (0.13 to 0.26) |
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| 15-49 years: Antibody Titers ≥ 2 | 94.29 (80.84 to 99.30) | 100.0 (90.97 to 100.0) | 96.30 (89.56 to 99.23) |
| ≥ 50 years: Antibody Titers ≥ 2 | 100.0 (75.29 to 100.0) | 100.0 (73.54 to 100.0) | 100.0 (86.28 to 100.0) |
| ≥ 60 years: Antibody Titers ≥ 2 | 100.0 (39.76 to 100.0) | 100.0 (29.24 to 100.0) | 100.0 (59.04 to 100.0) |
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| 15-49 years: Antibody Titers ≥ 2 | 91.43 (76.94 to 98.20) | 100.0 (90.97 to 100.0) | 93.83 (86.18 to 97.97) |
| ≥ 50 years: Antibody Titers ≥ 2 | 100.0 (75.29 to 100.0) | 100.0 (73.54 to 100.0) | 100.0 (86.28 to 100.0) |
| ≥ 60 years: Antibody Titers ≥ 2 | 100.0 (39.76 to 100.0) | 100.0 (29.24 to 100.0) | 100.0 (59.04 to 100.0) |
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| 15-49 years: Antibody Titers ≥ 2 | 88.57 (73.26 to 96.80) | 97.44 (86.52 to 99.94) | 92.59 (84.57 to 97.23) |
| ≥ 50 years: Antibody Titers ≥ 2 | 92.31 (63.97 to 99.81) | 100.0 (73.54 to 100.0) | 96.00 (79.65 to 99.90) |
| ≥ 60 years: Antibody Titers ≥ 2 | 100.0 (39.76 to 100.0) | 100.0 (29.24 to 100.0) | 100.0 (59.04 to 100.0) |
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| 15-49 years: Antibody Titers ≥ 2 | 88.57 (73.26 to 96.80) | 92.31 (79.13 to 98.38) | 91.36 (83.00 to 96.45) |
| ≥ 50 years: Antibody Titers ≥ 2 | 92.31 (63.97 to 99.81) | 100.0 (73.54 to 100.0) | 96.00 (79.65 to 99.90) |
| ≥ 60 years: Antibody Titers ≥ 2 | 100.0 (39.76 to 100.0) | 100.0 (29.24 to 100.0) | 100.0 (59.04 to 100.0) |
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| 15-49 years: Antibody Titers ≥ 2 | 88.57 (73.26 to 96.80) | 94.87 (82.68 to 99.37) | 92.59 (84.57 to 97.23) |
| ≥ 50 years: Antibody Titers ≥ 2 | 92.31 (63.97 to 99.81) | 100.0 (73.54 to 100.0) | 96.00 (79.65 to 99.90) |
| ≥ 60 years: Antibody Titers ≥ 2 | 100.0 (39.76 to 100.0) | 100.0 (29.24 to 100.0) | 100.0 (59.04 to 100.0) |
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| 15-49 years: Antibody Titers ≥ 10 | 94.29 (80.84 to 99.30) | 100.0 (90.97 to 100.0) | 96.30 (89.56 to 99.23) |
| ≥ 50 years: Antibody Titers ≥ 10 | 100.0 (75.29 to 100.0) | 100.0 (73.54 to 100.0) | 100.0 (86.28 to 100.0) |
| ≥ 60 years: Antibody Titers ≥ 10 | 100.0 (39.76 to 100.0) | 100.0 (29.24 to 100.0) | 100.0 (59.04 to 100.0) |
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
| Number of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| 15-49 years: Antibody Titers ≥ 10 | 91.43 (76.94 to 98.20) | 100.0 (90.97 to 100.0) | 93.83 (86.18 to 97.97) |
| ≥ 50 years: Antibody Titers ≥ 10 | 100.0 (75.29 to 100.0) | 100.0 (73.54 to 100.0) | 100.0 (86.28 to 100.0) |
| ≥ 60 years: Antibody Titers ≥ 10 | 100.0 (39.76 to 100.0) | 100.0 (29.24 to 100.0) | 100.0 (59.04 to 100.0) |
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| 15-49 years: Antibody Titers ≥ 10 | 88.57 (73.26 to 96.80) | 97.44 (86.52 to 99.94) | 91.36 (83.00 to 96.45) |
| ≥ 50 years: Antibody Titers ≥ 10 | 92.31 (63.97 to 99.81) | 100.0 (73.54 to 100.0) | 96.00 (79.65 to 99.90) |
| ≥ 60 years: Antibody Titers ≥ 10 | 100.0 (39.76 to 100.0) | 100.0 (29.24 to 100.0) | 100.0 (59.04 to 100.0) |
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| 15-49 years: Antibody Titers ≥ 10 | 88.57 (73.26 to 96.80) | 92.31 (79.13 to 98.38) | 91.36 (83.00 to 96.45) |
| ≥ 50 years: Antibody Titers ≥ 10 | 92.31 (63.97 to 99.81) | 100.0 (73.54 to 100.0) | 96.00 (79.65 to 99.90) |
| ≥ 60 years: Antibody Titers ≥ 10 | 100.0 (39.76 to 100.0) | 100.0 (29.24 to 100.0) | 100.0 (59.04 to 100.0) |
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
| Percentage of subjects | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| 15-49 years: Antibody Titers ≥ 10 | 88.57 (73.26 to 96.80) | 94.87 (82.68 to 99.37) | 92.59 (84.57 to 97.23) |
| ≥ 50 years: Antibody Titers ≥ 10 | 92.31 (63.97 to 99.81) | 91.67 (61.52 to 99.79) | 96.00 (79.65 to 99.90) |
| ≥ 60 years: Antibody Titers ≥ 10 | 100.0 (39.76 to 100.0) | 66.67 (9.43 to 99.16) | 100.0 (59.04 to 100.0) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | 76 (27 to 215) | 253 (153 to 417) | 263 (185 to 375) |
| Baseline GMT post booster | 638 (413 to 984) | 1299 (861 to 1959) | 1008 (757 to 1343) |
| GMT Year 6 | 332 (186 to 593) | 341 (197 to 590) | 235 (160 to 344) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | 76 (27 to 215) | 253 (153 to 417) | 263 (185 to 375) |
| Baseline GMT post booster | 638 (413 to 984) | 1299 (861 to 1959) | 1008 (757 to 1343) |
| GMT Year 7 | 304 (164 to 564) | 384 (214 to 691) | 250 (166 to 375) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | 76 (27 to 215) | 253 (153 to 417) | 263 (185 to 375) |
| Baseline GMT post booster | 638 (413 to 984) | 1299 (861 to 1959) | 1008 (757 to 1343) |
| GMT Year 8 | 151 (80 to 287) | 219 (119 to 402) | 160 (105 to 243) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | 76 (27 to 215) | 253 (153 to 417) | 263 (185 to 375) |
| Baseline GMT post booster | 638 (413 to 984) | 1299 (861 to 1959) | 1008 (757 to 1343) |
| GMT Year 9 | 218 (107 to 443) | 211 (108 to 413) | 191 (120 to 305) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | 76 (27 to 215) | 253 (153 to 417) | 263 (185 to 375) |
| Baseline GMT post booster | 638 (413 to 984) | 1299 (861 to 1959) | 1008 (757 to 1343) |
| GMT Year 10 | 188 (92 to 382) | 266 (136 to 520) | 200 (126 to 319) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | — | 163 (77 to 348) | 145 (86 to 244) |
| Baseline GMT post booster | 201 (111 to 364) | 733 (395 to 1361) | 914 (595 to 1403) |
| GMT Year 6 | 207 (107 to 401) | 178 (89 to 355) | 183 (114 to 295) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | — | 163 (77 to 348) | 145 (86 to 244) |
| Baseline GMT post booster | 201 (111 to 364) | 733 (395 to 1361) | 914 (595 to 1403) |
| GMT Year 7 | 272 (126 to 588) | 237 (107 to 528) | 270 (155 to 470) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | — | 163 (77 to 348) | 145 (86 to 244) |
| Baseline GMT post booster | 201 (111 to 364) | 733 (395 to 1361) | 914 (595 to 1403) |
| GMT Year 8 | 98 (39 to 245) | 189 (73 to 492) | 142 (73 to 275) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | — | 163 (77 to 348) | 145 (86 to 244) |
| Baseline GMT post booster | 201 (111 to 364) | 733 (395 to 1361) | 914 (595 to 1403) |
| GMT Year 9 | 193 (74 to 505) | 224 (82 to 609) | 202 (101 to 403) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | — | 163 (77 to 348) | 145 (86 to 244) |
| Baseline GMT post booster | 201 (111 to 364) | 733 (395 to 1361) | 914 (595 to 1403) |
| GMT Year 10 | 119 (47 to 302) | 189 (72 to 496) | 129 (66 to 251) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | — | 64 (13 to 316) | 69 (24 to 197) |
| Baseline GMT post booster | 173 (71 to 425) | 573 (203 to 1616) | 498 (253 to 982) |
| GMT Year 6 | 189 (52 to 688) | 96 (22 to 427) | 76 (29 to 202) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | — | 64 (31 to 316) | 69 (24 to 197) |
| Baseline GMT post booster | 173 (71 to 425) | 573 (203 to 1616) | 498 (253 to 982) |
| GMT Year 7 | 133 (26 to 677) | 120 (18 to 789) | 105 (31 to 360) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | — | 64 (13 to 316) | 69 (24 to 197) |
| Baseline GMT post booster | 173 (71 to 425) | 573 (203 to 1616) | 498 (253 to 982) |
| GMT Year 8 | 128 (26 to 620) | 81 (13 to 504) | 71 (21 to 234) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | — | 64 (13 to 316) | 69 (24 to 197) |
| Baseline GMT post booster | 173 (71 to 425) | 573 (203 to 1616) | 498 (253 to 982) |
| GMT Year 9 | 224 (52 to 965) | 67 (12 to 362) | 128 (42 to 385) |
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.
| Titers | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| Baseline GMT pre booster | — | 64 (13 to 316) | 69 (24 to 197) |
| Baseline GMT post booster | 173 (71 to 425) | 573 (203 to 1616) | 498 (253 to 982) |
| GMT Year 10 | 181 (35 to 928) | 57 (9 to 377) | 72 (21 to 248) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 6.73 (3.02 to 15.01) | 1.35 (0.92 to 1.98) | 0.92 (0.7 to 1.2) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 3.85 (1.34 to 11.04) | 1.52 (0.92 to 2.52) | 0.96 (0.68 to 1.38) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 0.67 (0.22 to 2.08) | 0.87 (0.5 to 1.49) | 0.62 (0.42 to 0.91) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 1.08 (0.3 to 3.88) | 0.84 (0.45 to 1.54) | 0.73 (0.47 to 1.12) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years | 0.76 (0.24 to 2.48) | 1.05 (0.6 to 1.85) | 0.78 (0.52 to 1.16) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | — | 1.09 (0.75 to 1.59) | 1.27 (0.98 to 1.64) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | — | 1.45 (1.01 to 2.1) | 1.87 (1.45 to 2.41) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | — | 1.16 (0.62 to 2.17) | 0.98 (0.63 to 1.52) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | — | 1.37 (0.71 to 2.65) | 1.39 (0.88 to 2.21) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years | — | 1.16 (0.63 to 2.12) | 0.89 (0.58 to 1.35) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | — | 1.5 (0.76 to 2.97) | 1.1 (0.7 to 1.72) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | — | 1.88 (0.97 to 3.64) | 1.52 (0.99 to 2.35) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | — | 1.27 (0.44 to 3.66) | 1.03 (0.51 to 2.05) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | — | 1.05 (0.37 to 2.94) | 1.85 (0.94 to 3.64) |
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).
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years | — | 0.89 (0.39 to 2.06) | 1.04 (0.6 to 1.81) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.52 (0.35 to 0.78) | 0.26 (0.18 to 0.38) | 0.23 (0.18 to 0.3) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.48 (0.28 to 0.81) | 0.3 (0.18 to 0.49) | 0.24 (0.17 to 0.35) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.24 (0.13 to 0.43) | 0.17 (0.1 to 0.3) | 0.16 (0.11 to 0.23) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.34 (0.18 to 0.66) | 0.16 (0.09 to 0.3) | 0.19 (0.12 to 0.3) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years | 0.29 (0.15 to 0.56) | 0.2 (0.11 to 0.38) | 0.2 (0.13 to 0.3) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 1.03 (0.7 to 1.52) | 0.24 (0.16 to 0.37) | 0.2 (0.15 to 0.27) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 1.36 (0.79 to 2.33) | 0.32 (0.18 to 0.57) | 0.3 (0.2 to 0.44) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.49 (0.23 to 1.04) | 0.26 (0.12 to 0.57) | 0.16 (0.09 to 0.27) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.96 (0.44 to 2.08) | 0.31 (0.14 to 0.68) | 0.22 (0.13 to 0.39) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years | 0.59 (0.28 to 1.24) | 0.26 (0.12 to 0.55) | 0.14 (0.08 to 0.24) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 1.09 (0.47 to 2.55) | 0.17 (0.06 to 0.45) | 0.15 (0.08 to 0.29) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.77 (0.21 to 2.86) | 0.21 (0.05 to 0.96) | 0.21 (0.08 to 0.57) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 0.74 (0.2 to 2.72) | 0.14 (0.03 to 0.64) | 0.14 (0.05 to 0.38) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 1.29 (0.43 to 3.84) | 0.12 (0.03 to 0.41) | 0.26 (0.11 to 0.58) |
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.
| Ratios | TBE_R Group | TBE_C Group | TBE_AC Group |
|---|---|---|---|
| GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years | 1.05 (0.31 to 3.49) | 0.1 (0.02 to 0.4) | 0.14 (0.06 to 0.36) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TBE_R Group | — | — | — |
| TBE_C Group | — | — | — |
| TBE_AC Group | — | — | — |
| Age, Continuous(Years) | TBE_R Group | TBE_C Group | TBE_AC Group | Total |
|---|---|---|---|---|
| Mean | 42.7 ± 15.25 | 41.8 ± 14.34 | 42.4 ± 14.35 | 42.3 ± 14.49 |
| Sex: Female, Male(Participants) | TBE_R Group | TBE_C Group | TBE_AC Group | Total |
|---|---|---|---|---|
| Female | 24 | 32 | 55 | 111 |
| Male | 24 | 19 | 51 | 94 |
| Race/Ethnicity, Customized(Participants) | TBE_R Group | TBE_C Group | TBE_AC Group | Total |
|---|---|---|---|---|
| White | 48 | 51 | 106 | 205 |
Ran from Mar 2012 to primary completion in Sep 2016, 54 months.
Results were first posted in Aug 2018, 1 year 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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