Clinical Trial Results:
A phase IV, openlabel, singlecenter study to evaluate long term immunogenicity up to 10 years after the first booster immunization with Tick Borne Encephalitis vaccine in adults who received 1 of 3 different primary vaccination schedules
Summary


EudraCT number 
201100325519 
Trial protocol 
CZ 
Global end of trial date 
30 Sep 2016

Results information


Results version number 
v4(current) 
This version publication date 
30 Jun 2018

First version publication date 
22 Feb 2015

Other versions 
v1 (removed from public view) , v2 , v3 
Version creation reason 

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information


Trial identification


Sponsor protocol code 
205335


Additional study identifiers


ISRCTN number 
  
US NCT number 
NCT01562444  
WHO universal trial number (UTN) 
  
Sponsors


Sponsor organisation name 
GlaxoSmithKline Biologicals


Sponsor organisation address 
Rue de l'Institut 89, Rixensart, Belgium,


Public contact 
Clinical Trials Call Center, GlaxoSmithKline Biologicals, (44)2089 904466, GSKClinicalSupportHD@gsk.com


Scientific contact 
Clinical Trials Call Center, GlaxoSmithKline Biologicals, (44)2089 904466, GSKClinicalSupportHD@gsk.com


Paediatric regulatory details


Is trial part of an agreed paediatric investigation plan (PIP) 
No


Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? 
No


Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? 
No


Results analysis stage


Analysis stage 
Final


Date of interim/final analysis 
30 Sep 2016


Is this the analysis of the primary completion data? 
Yes


Primary completion date 
30 Sep 2016


Global end of trial reached? 
Yes


Global end of trial date 
30 Sep 2016


Was the trial ended prematurely? 
No


General information about the trial


Main objective of the trial 
Immunogenicity Objectives:
To evaluate the persistence of antibody response to a booster vaccine starting 6 years after the booster administration and following subjects up to 10 years after first booster administration.


Protection of trial subjects 
The clinical study was designed, implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki. Eligible subjects were included in the study after providing written (witnessed, where required by law or regulation), Independent Ethics Committee (IEC)approved informed consent, or, if incapable of doing so, after such consent was provided by a legally acceptable representative of the subject.


Background therapy 
  
Evidence for comparator 
  
Actual start date of recruitment 
08 Mar 2012


Long term followup planned 
No


Independent data monitoring committee (IDMC) involvement? 
No


Population of trial subjects


Number of subjects enrolled per country 

Country: Number of subjects enrolled 
Czech Republic: 205


Worldwide total number of subjects 
205


EEA total number of subjects 
205


Number of subjects enrolled per age group 

In utero 
0


Preterm newborn  gestational age < 37 wk 
0


Newborns (027 days) 
0


Infants and toddlers (28 days23 months) 
0


Children (211 years) 
0


Adolescents (1217 years) 
0


Adults (1864 years) 
189


From 65 to 84 years 
16


85 years and over 
0



Recruitment


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.  
Preassignment


Screening 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.  
Preassignment period milestones


Number of subjects started 
205  
Number of subjects completed 
205  
Period 1


Period 1 title 
Overall Study (overall period)


Is this the baseline period? 
Yes  
Allocation method 
Not applicable


Blinding used 
Not blinded  
Arms


Are arms mutually exclusive 
Yes


Arm title

TBE_R Group  
Arm description 
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 1218 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).  
Arm type 
Blood draw  
Investigational medicinal product name 
Blood draw


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Anticoagulant and preservative solution for blood


Routes of administration 
Route of administration not applicable


Dosage and administration details 
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)


Arm title

TBE_C Group  
Arm description 
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.  
Arm type 
Blood draw  
Investigational medicinal product name 
Blood draw


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Anticoagulant and preservative solution for blood


Routes of administration 
Route of administration not applicable


Dosage and administration details 
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)


Arm title

TBE_AC Group  
Arm description 
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.  
Arm type 
Blood draw  
Investigational medicinal product name 
Blood draw


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Anticoagulant and preservative solution for blood


Routes of administration 
Route of administration not applicable


Dosage and administration details 
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)





Baseline characteristics reporting groups


Reporting group title 
TBE_R Group


Reporting group description 
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 1218 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).  
Reporting group title 
TBE_C Group


Reporting group description 
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.  
Reporting group title 
TBE_AC Group


Reporting group description 
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.  



End points reporting groups


Reporting group title 
TBE_R Group


Reporting group description 
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 1218 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).  
Reporting group title 
TBE_C Group


Reporting group description 
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.  
Reporting group title 
TBE_AC Group


Reporting group description 
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. 


End point title 
Percentage of subjects with detectable TBE antibody titers greater than or equal to (≥) 2 ^{[1]}  
End point description 
Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.


End point type 
Primary


End point timeframe 
At Year 6


Notes [1]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 2 ^{[2]}  
End point description 
Antibody titers were measured by GSK NT assay.


End point type 
Primary


End point timeframe 
At Year 7


Notes [2]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 2 ^{[3]}  
End point description 
Antibody titers were measured by GSK NT assay.


End point type 
Primary


End point timeframe 
At Year 8


Notes [3]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 2 ^{[4]}  
End point description 
Antibody titers were measured by GSK NT assay.


End point type 
Primary


End point timeframe 
At Year 9


Notes [4]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 2 ^{[5]}  
End point description 
Antibody titers were measured by GSK NT assay.


End point type 
Primary


End point timeframe 
At Year 10


Notes [5]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 10 ^{[6]}  
End point description 
Antibody titers were measured by GSK NT assay.


End point type 
Primary


End point timeframe 
At Year 6


Notes [6]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 10 ^{[7]}  
End point description 
Antibody titers were measured by GSK NT assay.


End point type 
Primary


End point timeframe 
At Year 7


Notes [7]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 10 ^{[8]}  
End point description 
Antibody titers were measured by GSK NT assay.


End point type 
Primary


End point timeframe 
At Year 8


Notes [8]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 10 ^{[9]}  
End point description 
Antibody titers were measured by GSK NT assay.


End point type 
Primary


End point timeframe 
At Year 9


Notes [9]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 10 ^{[10]}  
End point description 
Antibody titers were measured by GSK NT assay.


End point type 
Primary


End point timeframe 
At Year 10


Notes [10]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of Geometric Mean Antibody Titers (GMTs) ^{[11]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate Geometric Mean Ratios (GMRs). Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 6


Notes [11]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs ^{[12]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 7


Notes [12]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs ^{[13]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At year 8


Notes [13]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs ^{[14]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 9


Notes [14]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs ^{[15]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 10


Notes [15]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Geometric Mean Ratios (GMRs) calculated to pre booster baselines ^{[16]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 6


Notes [16]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines ^{[17]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 7


Notes [17]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines ^{[18]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 8


Notes [18]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines ^{[19]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 9


Notes [19]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines ^{[20]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 10


Notes [20]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines ^{[21]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 6


Notes [21]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines ^{[22]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 7


Notes [22]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines ^{[23]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 8


Notes [23]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines ^{[24]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 9


Notes [24]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines ^{[25]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 10


Notes [25]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups ^{[26]}  
End point description 
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.


End point type 
Primary


End point timeframe 
At Year 6


Notes [26]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups ^{[27]}  
End point description 
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.


End point type 
Primary


End point timeframe 
At Year 7


Notes [27]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups ^{[28]}  
End point description 
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.


End point type 
Primary


End point timeframe 
At Year 8


Notes [28]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups ^{[29]}  
End point description 
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.


End point type 
Primary


End point timeframe 
At Year 9


Notes [29]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 2 by age groups ^{[30]}  
End point description 
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.


End point type 
Primary


End point timeframe 
At Year 10


Notes [30]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups ^{[31]}  
End point description 
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.


End point type 
Primary


End point timeframe 
At Year 6


Notes [31]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups ^{[32]}  
End point description 
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.


End point type 
Primary


End point timeframe 
At Year 7


Notes [32]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups ^{[33]}  
End point description 
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.


End point type 
Primary


End point timeframe 
At Year 8


Notes [33]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups ^{[34]}  
End point description 
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.


End point type 
Primary


End point timeframe 
At Year 9


Notes [34]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Percentage of subjects with detectable TBE antibody titers ≥ 10 by age groups ^{[35]}  
End point description 
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.


End point type 
Primary


End point timeframe 
At Year 10


Notes [35]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of 1549 years ^{[36]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 6


Notes [36]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of 1549 years ^{[37]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 7


Notes [37]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of 1549 years ^{[38]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 8


Notes [38]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of 1549 years ^{[39]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 9


Notes [39]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of 1549 years ^{[40]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 10


Notes [40]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of ≥ 50 years ^{[41]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 6


Notes [41]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of ≥ 50 years ^{[42]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 7


Notes [42]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of ≥ 50 years ^{[43]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 8


Notes [43]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of ≥ 50 years ^{[44]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 9


Notes [44]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of ≥ 50 years ^{[45]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 10


Notes [45]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of ≥ 60 years ^{[46]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 6


Notes [46]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of ≥ 60 years ^{[47]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 7


Notes [47]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of ≥ 60 years ^{[48]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 8


Notes [48]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of ≥ 60 years ^{[49]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 9


Notes [49]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
Evaluation of GMTs in the age group of ≥ 60 years ^{[50]}  
End point description 
GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 10


Notes [50]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of 1549 years ^{[51]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 6


Notes [51]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of 1549 years ^{[52]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 7


Notes [52]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of 1549 years ^{[53]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 8


Notes [53]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of 1549 years ^{[54]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 9


Notes [54]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of 1549 years ^{[55]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 10


Notes [55]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of ≥ 50 years ^{[56]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 6


Notes [56]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



Notes [57]  There were no subjects in the TBE_R group with baselines calculated using pre booster values 

No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of ≥ 50 years ^{[58]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 7


Notes [58]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



Notes [59]  There were no subjects in the TBE_R group with baselines calculated using pre booster values 

No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of ≥ 50 years ^{[60]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 8


Notes [60]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



Notes [61]  There were no subjects in the TBE_R group with baselines calculated using pre booster values 

No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of ≥ 50 years ^{[62]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 9


Notes [62]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



Notes [63]  There were no subjects in the TBE_R group with baselines calculated using pre booster values 

No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of ≥ 50 years ^{[64]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 10


Notes [64]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



Notes [65]  There were no subjects in the TBE_R group with baselines calculated using pre booster values 

No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of ≥ 60 years ^{[66]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 6


Notes [66]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



Notes [67]  There were no subjects in the TBE_R group with baselines calculated using pre booster values 

No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of ≥ 60 years ^{[68]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 7


Notes [68]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



Notes [69]  There were no subjects in the TBE_R group with baselines calculated using pre booster values 

No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of ≥ 60 years ^{[70]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 8


Notes [70]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



Notes [71]  There were no subjects in the TBE_R group with baselines calculated using pre booster values 

No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of ≥ 60 years ^{[72]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 9


Notes [72]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



Notes [73]  There were no subjects in the TBE_R group with baselines calculated using pre booster values 

No statistical analyses for this end point 


End point title 
GMRs calculated to pre booster baselines in the age group of ≥ 60 years ^{[74]}  
End point description 
GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).


End point type 
Primary


End point timeframe 
At Year 10


Notes [74]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



Notes [75]  There were no subjects in the TBE_R group with baselines calculated using pre booster values 

No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of 1549 years ^{[76]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 6


Notes [76]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of 1549 years ^{[77]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 7


Notes [77]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of 1549 years ^{[78]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 8


Notes [78]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of 1549 years ^{[79]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 9


Notes [79]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of 1549 years ^{[80]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 10


Notes [80]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of ≥ 50 years ^{[81]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 6


Notes [81]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of ≥ 50 years ^{[82]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 7


Notes [82]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of ≥ 50 years ^{[83]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 8


Notes [83]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of ≥ 50 years ^{[84]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 9


Notes [84]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of ≥ 50 years ^{[85]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 10


Notes [85]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of ≥ 60 years ^{[86]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 6


Notes [86]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of ≥ 60 years ^{[87]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 7


Notes [87]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of ≥ 60 years ^{[88]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 8


Notes [88]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of ≥ 60 years ^{[89]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 9


Notes [89]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


End point title 
GMRs calculated to post booster baselines in the age group of ≥ 60 years ^{[90]}  
End point description 
GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.


End point type 
Primary


End point timeframe 
At Year 10


Notes [90]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. 



No statistical analyses for this end point 


Adverse events information ^{[1]}


Timeframe for reporting adverse events 
Not applicable (NA)


Adverse event reporting additional description 
The study was intended to evaluate the persistence of antibody response up to 10 years after booster vaccine administration. Safety profile of the vaccine was not evaluated as per study protocol. Hence, there are no safety results as per planned analysis.


Assessment type 
Systematic  
Dictionary used for adverse event reporting


Dictionary name 
NA  
Dictionary version 
NA


Frequency threshold for reporting nonserious adverse events: 5%  
Notes [1]  There are no nonserious adverse events recorded for these results. It is expected that there will be at least one nonserious adverse event reported. Justification: The study was intended to evaluate the persistence of antibody response up to 10 years after booster vaccine administration. Safety profile of the vaccine was not evaluated as per study protocol. Hence, there are no safety results as per planned analysis. 


Substantial protocol amendments (globally) 

Were there any global substantial amendments to the protocol? No  
Interruptions (globally) 

Were there any global interruptions to the trial? No  
Limitations and caveats 

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.  
None reported 