Trial Outcomes & Findings for 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 (NCT NCT01562444)
NCT ID: NCT01562444
Last Updated: 2021-08-12
Results Overview
Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.
COMPLETED
PHASE4
206 participants
At Year 6
2021-08-12
Participant Flow
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.
206 subjects were enrolled in the study but one subject was not assigned to any group. Therefore, the number of subjects started is 205.
Participant milestones
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
|
TBE_AC Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
51
|
106
|
|
Overall Study
COMPLETED
|
43
|
49
|
99
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
7
|
Reasons for withdrawal
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
|
TBE_AC Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
|
|---|---|---|---|
|
Overall Study
Did not meet entry criteria
|
2
|
0
|
3
|
|
Overall Study
Did not comply with blood draw schedule
|
1
|
0
|
1
|
|
Overall Study
Unavailable serological results
|
0
|
2
|
2
|
|
Overall Study
Protocol forbidden concomitant vaccine
|
1
|
0
|
1
|
|
Overall Study
Protocol forbidden medication
|
1
|
0
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.7 Years
STANDARD_DEVIATION 15.25 • n=5 Participants
|
41.8 Years
STANDARD_DEVIATION 14.34 • n=7 Participants
|
42.4 Years
STANDARD_DEVIATION 14.35 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 14.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
48 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
205 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2
|
95.83 Percentage of subjects
Interval 85.75 to 99.49
|
100.0 Percentage of subjects
Interval 93.02 to 100.0
|
97.17 Percentage of subjects
Interval 91.95 to 99.41
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Antibody titers were measured by GSK NT assay.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
|
93.75 Percentage of subjects
Interval 82.8 to 98.69
|
100.0 Percentage of subjects
Interval 93.02 to 100.0
|
95.28 Percentage of subjects
Interval 89.33 to 98.45
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Antibody titers were measured by GSK NT assay.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
|
89.58 Percentage of subjects
Interval 77.34 to 96.53
|
98.04 Percentage of subjects
Interval 89.55 to 99.95
|
93.40 Percentage of subjects
Interval 86.87 to 97.3
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Antibody titers were measured by GSK NT assay.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
|
89.58 Percentage of subjects
Interval 77.34 to 96.53
|
94.12 Percentage of subjects
Interval 83.76 to 98.77
|
92.45 Percentage of subjects
Interval 85.67 to 96.69
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Antibody titers were measured by GSK NT assay.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
|
89.58 Percentage of subjects
Interval 77.34 to 96.53
|
96.08 Percentage of subjects
Interval 86.54 to 99.52
|
93.40 Percentage of subjects
Interval 86.87 to 97.3
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Antibody titers were measured by GSK NT assay.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
|
95.83 Percentage of subjects
Interval 85.75 to 99.49
|
100.0 Percentage of subjects
Interval 93.02 to 100.0
|
97.17 Percentage of subjects
Interval 91.95 to 99.41
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Antibody titers were measured by GSK NT assay.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
|
93.75 Percentage of subjects
Interval 82.8 to 98.69
|
100.0 Percentage of subjects
Interval 93.02 to 100.0
|
95.28 Percentage of subjects
Interval 89.33 to 98.45
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Antibody titers were measured by GSK NT assay.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
|
89.58 Percentage of subjects
Interval 77.34 to 96.53
|
98.04 Percentage of subjects
Interval 89.55 to 99.95
|
92.45 Percentage of subjects
Interval 85.67 to 96.69
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Antibody titers were measured by GSK NT assay.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
|
89.58 Percentage of subjects
Interval 77.34 to 96.53
|
94.12 Percentage of subjects
Interval 83.76 to 98.77
|
92.45 Percentage of subjects
Interval 85.67 to 96.69
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Antibody titers were measured by GSK NT assay.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
|
89.58 Percentage of subjects
Interval 77.34 to 96.53
|
94.12 Percentage of subjects
Interval 83.76 to 98.77
|
93.40 Percentage of subjects
Interval 86.87 to 97.3
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Evaluation of Geometric Mean Antibody Titers (GMTs)
Baseline GMT pre booster
|
76 Titers
Interval 28.0 to 208.0
|
228 Titers
Interval 149.0 to 348.0
|
228 Titers
Interval 170.0 to 307.0
|
|
Evaluation of Geometric Mean Antibody Titers (GMTs)
Baseline GMT post booster
|
467 Titers
Interval 325.0 to 670.0
|
1135 Titers
Interval 799.0 to 1611.0
|
985 Titers
Interval 771.0 to 1257.0
|
|
Evaluation of Geometric Mean Antibody Titers (GMTs)
GMT Year 6
|
292 Titers
Interval 184.0 to 463.0
|
293 Titers
Interval 187.0 to 458.0
|
221 Titers
Interval 162.0 to 302.0
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs
Baseline GMT pre booster
|
76 Titers
Interval 28.0 to 208.0
|
228 Titers
Interval 149.0 to 348.0
|
228 Titers
Interval 170.0 to 307.0
|
|
Evaluation of GMTs
Baseline GMT post booster
|
467 Titers
Interval 325.0 to 670.0
|
1135 Titers
Interval 799.0 to 1611.0
|
985 Titers
Interval 771.0 to 1257.0
|
|
Evaluation of GMTs
GMT Year 7
|
295 Titers
Interval 180.0 to 484.0
|
343 Titers
Interval 212.0 to 555.0
|
254 Titers
Interval 182.0 to 355.0
|
PRIMARY outcome
Timeframe: At year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs
Baseline GMT pre booster
|
76 Titers
Interval 28.0 to 208.0
|
228 Titers
Interval 149.0 to 348.0
|
228 Titers
Interval 170.0 to 307.0
|
|
Evaluation of GMTs
Baseline GMT post booster
|
467 Titers
Interval 325.0 to 670.0
|
1135 Titers
Interval 799.0 to 1611.0
|
985 Titers
Interval 771.0 to 1257.0
|
|
Evaluation of GMTs
GMT Year 8
|
134 Titers
Interval 79.0 to 227.0
|
211 Titers
Interval 127.0 to 352.0
|
155 Titers
Interval 109.0 to 221.0
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs
Baseline GMT pre booster
|
76 Titers
Interval 28.0 to 208.0
|
228 Titers
Interval 149.0 to 348.0
|
228 Titers
Interval 170.0 to 307.0
|
|
Evaluation of GMTs
Baseline GMT post booster
|
467 Titers
Interval 325.0 to 670.0
|
1135 Titers
Interval 799.0 to 1611.0
|
985 Titers
Interval 771.0 to 1257.0
|
|
Evaluation of GMTs
GMT Year 9
|
211 Titers
Interval 119.0 to 375.0
|
214 Titers
Interval 122.0 to 374.0
|
194 Titers
Interval 131.0 to 285.0
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=106 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs
Baseline GMT pre booster
|
76 Titers
Interval 28.0 to 208.0
|
228 Titers
Interval 149.0 to 348.0
|
228 Titers
Interval 170.0 to 307.0
|
|
Evaluation of GMTs
Baseline GMT post booster
|
467 Titers
Interval 325.0 to 670.0
|
1135 Titers
Interval 799.0 to 1611.0
|
985 Titers
Interval 771.0 to 1257.0
|
|
Evaluation of GMTs
GMT Year 10
|
166 Titers
Interval 94.0 to 295.0
|
245 Titers
Interval 140.0 to 428.0
|
180 Titers
Interval 122.0 to 265.0
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
n=9 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=104 Participants
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.
|
|---|---|---|---|
|
Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines
|
6.73 Ratios
Interval 3.23 to 14.02
|
1.28 Ratios
Interval 0.94 to 1.75
|
0.99 Ratios
Interval 0.8 to 1.23
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
n=9 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=104 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines
|
3.85 Ratios
Interval 1.48 to 10.0
|
1.51 Ratios
Interval 1.01 to 2.25
|
1.13 Ratios
Interval 0.85 to 1.5
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
n=9 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=104 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines
|
0.67 Ratios
Interval 0.23 to 1.91
|
0.93 Ratios
Interval 0.6 to 1.44
|
0.69 Ratios
Interval 0.51 to 0.95
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
n=9 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=104 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines
|
1.08 Ratios
Interval 0.33 to 3.53
|
0.94 Ratios
Interval 0.57 to 1.54
|
0.85 Ratios
Interval 0.6 to 1.21
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
n=9 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=104 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines
|
0.76 Ratios
Interval 0.26 to 2.24
|
1.08 Ratios
Interval 0.68 to 1.69
|
0.8 Ratios
Interval 0.59 to 1.1
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=105 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines
|
0.63 Ratios
Interval 0.46 to 0.86
|
0.26 Ratios
Interval 0.19 to 0.35
|
0.22 Ratios
Interval 0.18 to 0.28
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=105 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines
|
0.63 Ratios
Interval 0.41 to 0.96
|
0.3 Ratios
Interval 0.2 to 0.46
|
0.25 Ratios
Interval 0.19 to 0.34
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=105 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines
|
0.29 Ratios
Interval 0.18 to 0.47
|
0.19 Ratios
Interval 0.12 to 0.3
|
0.16 Ratios
Interval 0.11 to 0.22
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=105 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines
|
0.45 Ratios
Interval 0.27 to 0.77
|
0.19 Ratios
Interval 0.11 to 0.32
|
0.2 Ratios
Interval 0.14 to 0.28
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=48 Participants
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).
|
TBE_C Group
n=51 Participants
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.
|
TBE_AC Group
n=105 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines
|
0.36 Ratios
Interval 0.21 to 0.6
|
0.22 Ratios
Interval 0.13 to 0.36
|
0.18 Ratios
Interval 0.13 to 0.26
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
15-49 years: Antibody Titers ≥ 2
|
94.29 Percentage of subjects
Interval 80.84 to 99.3
|
100.0 Percentage of subjects
Interval 90.97 to 100.0
|
96.30 Percentage of subjects
Interval 89.56 to 99.23
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
≥ 50 years: Antibody Titers ≥ 2
|
100.0 Percentage of subjects
Interval 75.29 to 100.0
|
100.0 Percentage of subjects
Interval 73.54 to 100.0
|
100.0 Percentage of subjects
Interval 86.28 to 100.0
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
≥ 60 years: Antibody Titers ≥ 2
|
100.0 Percentage of subjects
Interval 39.76 to 100.0
|
100.0 Percentage of subjects
Interval 29.24 to 100.0
|
100.0 Percentage of subjects
Interval 59.04 to 100.0
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
15-49 years: Antibody Titers ≥ 2
|
91.43 Percentage of subjects
Interval 76.94 to 98.2
|
100.0 Percentage of subjects
Interval 90.97 to 100.0
|
93.83 Percentage of subjects
Interval 86.18 to 97.97
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
≥ 50 years: Antibody Titers ≥ 2
|
100.0 Percentage of subjects
Interval 75.29 to 100.0
|
100.0 Percentage of subjects
Interval 73.54 to 100.0
|
100.0 Percentage of subjects
Interval 86.28 to 100.0
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
≥ 60 years: Antibody Titers ≥ 2
|
100.0 Percentage of subjects
Interval 39.76 to 100.0
|
100.0 Percentage of subjects
Interval 29.24 to 100.0
|
100.0 Percentage of subjects
Interval 59.04 to 100.0
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
15-49 years: Antibody Titers ≥ 2
|
88.57 Percentage of subjects
Interval 73.26 to 96.8
|
97.44 Percentage of subjects
Interval 86.52 to 99.94
|
92.59 Percentage of subjects
Interval 84.57 to 97.23
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
≥ 50 years: Antibody Titers ≥ 2
|
92.31 Percentage of subjects
Interval 63.97 to 99.81
|
100.0 Percentage of subjects
Interval 73.54 to 100.0
|
96.00 Percentage of subjects
Interval 79.65 to 99.9
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
≥ 60 years: Antibody Titers ≥ 2
|
100.0 Percentage of subjects
Interval 39.76 to 100.0
|
100.0 Percentage of subjects
Interval 29.24 to 100.0
|
100.0 Percentage of subjects
Interval 59.04 to 100.0
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
15-49 years: Antibody Titers ≥ 2
|
88.57 Percentage of subjects
Interval 73.26 to 96.8
|
92.31 Percentage of subjects
Interval 79.13 to 98.38
|
91.36 Percentage of subjects
Interval 83.0 to 96.45
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
≥ 50 years: Antibody Titers ≥ 2
|
92.31 Percentage of subjects
Interval 63.97 to 99.81
|
100.0 Percentage of subjects
Interval 73.54 to 100.0
|
96.00 Percentage of subjects
Interval 79.65 to 99.9
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
≥ 60 years: Antibody Titers ≥ 2
|
100.0 Percentage of subjects
Interval 39.76 to 100.0
|
100.0 Percentage of subjects
Interval 29.24 to 100.0
|
100.0 Percentage of subjects
Interval 59.04 to 100.0
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
15-49 years: Antibody Titers ≥ 2
|
88.57 Percentage of subjects
Interval 73.26 to 96.8
|
94.87 Percentage of subjects
Interval 82.68 to 99.37
|
92.59 Percentage of subjects
Interval 84.57 to 97.23
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
≥ 50 years: Antibody Titers ≥ 2
|
92.31 Percentage of subjects
Interval 63.97 to 99.81
|
100.0 Percentage of subjects
Interval 73.54 to 100.0
|
96.00 Percentage of subjects
Interval 79.65 to 99.9
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
≥ 60 years: Antibody Titers ≥ 2
|
100.0 Percentage of subjects
Interval 39.76 to 100.0
|
100.0 Percentage of subjects
Interval 29.24 to 100.0
|
100.0 Percentage of subjects
Interval 59.04 to 100.0
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
15-49 years: Antibody Titers ≥ 10
|
94.29 Percentage of subjects
Interval 80.84 to 99.3
|
100.0 Percentage of subjects
Interval 90.97 to 100.0
|
96.30 Percentage of subjects
Interval 89.56 to 99.23
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
≥ 50 years: Antibody Titers ≥ 10
|
100.0 Percentage of subjects
Interval 75.29 to 100.0
|
100.0 Percentage of subjects
Interval 73.54 to 100.0
|
100.0 Percentage of subjects
Interval 86.28 to 100.0
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
≥ 60 years: Antibody Titers ≥ 10
|
100.0 Percentage of subjects
Interval 39.76 to 100.0
|
100.0 Percentage of subjects
Interval 29.24 to 100.0
|
100.0 Percentage of subjects
Interval 59.04 to 100.0
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
15-49 years: Antibody Titers ≥ 10
|
91.43 Number of subjects
Interval 76.94 to 98.2
|
100.0 Number of subjects
Interval 90.97 to 100.0
|
93.83 Number of subjects
Interval 86.18 to 97.97
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
≥ 50 years: Antibody Titers ≥ 10
|
100.0 Number of subjects
Interval 75.29 to 100.0
|
100.0 Number of subjects
Interval 73.54 to 100.0
|
100.0 Number of subjects
Interval 86.28 to 100.0
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
≥ 60 years: Antibody Titers ≥ 10
|
100.0 Number of subjects
Interval 39.76 to 100.0
|
100.0 Number of subjects
Interval 29.24 to 100.0
|
100.0 Number of subjects
Interval 59.04 to 100.0
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
15-49 years: Antibody Titers ≥ 10
|
88.57 Percentage of subjects
Interval 73.26 to 96.8
|
97.44 Percentage of subjects
Interval 86.52 to 99.94
|
91.36 Percentage of subjects
Interval 83.0 to 96.45
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
≥ 50 years: Antibody Titers ≥ 10
|
92.31 Percentage of subjects
Interval 63.97 to 99.81
|
100.0 Percentage of subjects
Interval 73.54 to 100.0
|
96.00 Percentage of subjects
Interval 79.65 to 99.9
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
≥ 60 years: Antibody Titers ≥ 10
|
100.0 Percentage of subjects
Interval 39.76 to 100.0
|
100.0 Percentage of subjects
Interval 29.24 to 100.0
|
100.0 Percentage of subjects
Interval 59.04 to 100.0
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
15-49 years: Antibody Titers ≥ 10
|
88.57 Percentage of subjects
Interval 73.26 to 96.8
|
92.31 Percentage of subjects
Interval 79.13 to 98.38
|
91.36 Percentage of subjects
Interval 83.0 to 96.45
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
≥ 50 years: Antibody Titers ≥ 10
|
92.31 Percentage of subjects
Interval 63.97 to 99.81
|
100.0 Percentage of subjects
Interval 73.54 to 100.0
|
96.00 Percentage of subjects
Interval 79.65 to 99.9
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
≥ 60 years: Antibody Titers ≥ 10
|
100.0 Percentage of subjects
Interval 39.76 to 100.0
|
100.0 Percentage of subjects
Interval 29.24 to 100.0
|
100.0 Percentage of subjects
Interval 59.04 to 100.0
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
15-49 years: Antibody Titers ≥ 10
|
88.57 Percentage of subjects
Interval 73.26 to 96.8
|
94.87 Percentage of subjects
Interval 82.68 to 99.37
|
92.59 Percentage of subjects
Interval 84.57 to 97.23
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
≥ 50 years: Antibody Titers ≥ 10
|
92.31 Percentage of subjects
Interval 63.97 to 99.81
|
91.67 Percentage of subjects
Interval 61.52 to 99.79
|
96.00 Percentage of subjects
Interval 79.65 to 99.9
|
|
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
≥ 60 years: Antibody Titers ≥ 10
|
100.0 Percentage of subjects
Interval 39.76 to 100.0
|
66.67 Percentage of subjects
Interval 9.43 to 99.16
|
100.0 Percentage of subjects
Interval 59.04 to 100.0
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of 15-49 Years
Baseline GMT pre booster
|
76 Titers
Interval 27.0 to 215.0
|
253 Titers
Interval 153.0 to 417.0
|
263 Titers
Interval 185.0 to 375.0
|
|
Evaluation of GMTs in the Age Group of 15-49 Years
Baseline GMT post booster
|
638 Titers
Interval 413.0 to 984.0
|
1299 Titers
Interval 861.0 to 1959.0
|
1008 Titers
Interval 757.0 to 1343.0
|
|
Evaluation of GMTs in the Age Group of 15-49 Years
GMT Year 6
|
332 Titers
Interval 186.0 to 593.0
|
341 Titers
Interval 197.0 to 590.0
|
235 Titers
Interval 160.0 to 344.0
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of 15-49 Years
Baseline GMT pre booster
|
76 Titers
Interval 27.0 to 215.0
|
253 Titers
Interval 153.0 to 417.0
|
263 Titers
Interval 185.0 to 375.0
|
|
Evaluation of GMTs in the Age Group of 15-49 Years
Baseline GMT post booster
|
638 Titers
Interval 413.0 to 984.0
|
1299 Titers
Interval 861.0 to 1959.0
|
1008 Titers
Interval 757.0 to 1343.0
|
|
Evaluation of GMTs in the Age Group of 15-49 Years
GMT Year 7
|
304 Titers
Interval 164.0 to 564.0
|
384 Titers
Interval 214.0 to 691.0
|
250 Titers
Interval 166.0 to 375.0
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of 15-49 Years
Baseline GMT pre booster
|
76 Titers
Interval 27.0 to 215.0
|
253 Titers
Interval 153.0 to 417.0
|
263 Titers
Interval 185.0 to 375.0
|
|
Evaluation of GMTs in the Age Group of 15-49 Years
Baseline GMT post booster
|
638 Titers
Interval 413.0 to 984.0
|
1299 Titers
Interval 861.0 to 1959.0
|
1008 Titers
Interval 757.0 to 1343.0
|
|
Evaluation of GMTs in the Age Group of 15-49 Years
GMT Year 8
|
151 Titers
Interval 80.0 to 287.0
|
219 Titers
Interval 119.0 to 402.0
|
160 Titers
Interval 105.0 to 243.0
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of 15-49 Years
Baseline GMT pre booster
|
76 Titers
Interval 27.0 to 215.0
|
253 Titers
Interval 153.0 to 417.0
|
263 Titers
Interval 185.0 to 375.0
|
|
Evaluation of GMTs in the Age Group of 15-49 Years
Baseline GMT post booster
|
638 Titers
Interval 413.0 to 984.0
|
1299 Titers
Interval 861.0 to 1959.0
|
1008 Titers
Interval 757.0 to 1343.0
|
|
Evaluation of GMTs in the Age Group of 15-49 Years
GMT Year 9
|
218 Titers
Interval 107.0 to 443.0
|
211 Titers
Interval 108.0 to 413.0
|
191 Titers
Interval 120.0 to 305.0
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=81 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of 15-49 Years
Baseline GMT pre booster
|
76 Titers
Interval 27.0 to 215.0
|
253 Titers
Interval 153.0 to 417.0
|
263 Titers
Interval 185.0 to 375.0
|
|
Evaluation of GMTs in the Age Group of 15-49 Years
Baseline GMT post booster
|
638 Titers
Interval 413.0 to 984.0
|
1299 Titers
Interval 861.0 to 1959.0
|
1008 Titers
Interval 757.0 to 1343.0
|
|
Evaluation of GMTs in the Age Group of 15-49 Years
GMT Year 10
|
188 Titers
Interval 92.0 to 382.0
|
266 Titers
Interval 136.0 to 520.0
|
200 Titers
Interval 126.0 to 319.0
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=13 Participants
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).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
Baseline GMT pre booster
|
—
|
163 Titers
Interval 77.0 to 348.0
|
145 Titers
Interval 86.0 to 244.0
|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
Baseline GMT post booster
|
201 Titers
Interval 111.0 to 364.0
|
733 Titers
Interval 395.0 to 1361.0
|
914 Titers
Interval 595.0 to 1403.0
|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMT Year 6
|
207 Titers
Interval 107.0 to 401.0
|
178 Titers
Interval 89.0 to 355.0
|
183 Titers
Interval 114.0 to 295.0
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=13 Participants
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).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
Baseline GMT pre booster
|
—
|
163 Titers
Interval 77.0 to 348.0
|
145 Titers
Interval 86.0 to 244.0
|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
Baseline GMT post booster
|
201 Titers
Interval 111.0 to 364.0
|
733 Titers
Interval 395.0 to 1361.0
|
914 Titers
Interval 595.0 to 1403.0
|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMT Year 7
|
272 Titers
Interval 126.0 to 588.0
|
237 Titers
Interval 107.0 to 528.0
|
270 Titers
Interval 155.0 to 470.0
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=13 Participants
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).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
Baseline GMT pre booster
|
—
|
163 Titers
Interval 77.0 to 348.0
|
145 Titers
Interval 86.0 to 244.0
|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
Baseline GMT post booster
|
201 Titers
Interval 111.0 to 364.0
|
733 Titers
Interval 395.0 to 1361.0
|
914 Titers
Interval 595.0 to 1403.0
|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMT Year 8
|
98 Titers
Interval 39.0 to 245.0
|
189 Titers
Interval 73.0 to 492.0
|
142 Titers
Interval 73.0 to 275.0
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=13 Participants
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).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
Baseline GMT pre booster
|
—
|
163 Titers
Interval 77.0 to 348.0
|
145 Titers
Interval 86.0 to 244.0
|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
Baseline GMT post booster
|
201 Titers
Interval 111.0 to 364.0
|
733 Titers
Interval 395.0 to 1361.0
|
914 Titers
Interval 595.0 to 1403.0
|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMT Year 9
|
193 Titers
Interval 74.0 to 505.0
|
224 Titers
Interval 82.0 to 609.0
|
202 Titers
Interval 101.0 to 403.0
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=13 Participants
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).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
Baseline GMT pre booster
|
—
|
163 Titers
Interval 77.0 to 348.0
|
145 Titers
Interval 86.0 to 244.0
|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
Baseline GMT post booster
|
201 Titers
Interval 111.0 to 364.0
|
733 Titers
Interval 395.0 to 1361.0
|
914 Titers
Interval 595.0 to 1403.0
|
|
Evaluation of GMTs in the Age Group of ≥ 50 Years
GMT Year 10
|
119 Titers
Interval 47.0 to 302.0
|
189 Titers
Interval 72.0 to 496.0
|
129 Titers
Interval 66.0 to 251.0
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=4 Participants
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).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
Baseline GMT pre booster
|
—
|
64 Titers
Interval 13.0 to 316.0
|
69 Titers
Interval 24.0 to 197.0
|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
Baseline GMT post booster
|
173 Titers
Interval 71.0 to 425.0
|
573 Titers
Interval 203.0 to 1616.0
|
498 Titers
Interval 253.0 to 982.0
|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMT Year 6
|
189 Titers
Interval 52.0 to 688.0
|
96 Titers
Interval 22.0 to 427.0
|
76 Titers
Interval 29.0 to 202.0
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=4 Participants
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).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
Baseline GMT pre booster
|
—
|
64 Titers
Interval 31.0 to 316.0
|
69 Titers
Interval 24.0 to 197.0
|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
Baseline GMT post booster
|
173 Titers
Interval 71.0 to 425.0
|
573 Titers
Interval 203.0 to 1616.0
|
498 Titers
Interval 253.0 to 982.0
|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMT Year 7
|
133 Titers
Interval 26.0 to 677.0
|
120 Titers
Interval 18.0 to 789.0
|
105 Titers
Interval 31.0 to 360.0
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=4 Participants
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).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
Baseline GMT pre booster
|
—
|
64 Titers
Interval 13.0 to 316.0
|
69 Titers
Interval 24.0 to 197.0
|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
Baseline GMT post booster
|
173 Titers
Interval 71.0 to 425.0
|
573 Titers
Interval 203.0 to 1616.0
|
498 Titers
Interval 253.0 to 982.0
|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMT Year 8
|
128 Titers
Interval 26.0 to 620.0
|
81 Titers
Interval 13.0 to 504.0
|
71 Titers
Interval 21.0 to 234.0
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=4 Participants
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).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
Baseline GMT post booster
|
173 Titers
Interval 71.0 to 425.0
|
573 Titers
Interval 203.0 to 1616.0
|
498 Titers
Interval 253.0 to 982.0
|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMT Year 9
|
224 Titers
Interval 52.0 to 965.0
|
67 Titers
Interval 12.0 to 362.0
|
128 Titers
Interval 42.0 to 385.0
|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
Baseline GMT pre booster
|
—
|
64 Titers
Interval 13.0 to 316.0
|
69 Titers
Interval 24.0 to 197.0
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=4 Participants
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).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
Baseline GMT pre booster
|
—
|
64 Titers
Interval 13.0 to 316.0
|
69 Titers
Interval 24.0 to 197.0
|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
Baseline GMT post booster
|
173 Titers
Interval 71.0 to 425.0
|
573 Titers
Interval 203.0 to 1616.0
|
498 Titers
Interval 253.0 to 982.0
|
|
Evaluation of GMTs in the Age Group of ≥ 60 Years
GMT Year 10
|
181 Titers
Interval 35.0 to 928.0
|
57 Titers
Interval 9.0 to 377.0
|
72 Titers
Interval 21.0 to 248.0
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
n=9 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=79 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
|
6.73 Ratios
Interval 3.02 to 15.01
|
1.35 Ratios
Interval 0.92 to 1.98
|
0.92 Ratios
Interval 0.7 to 1.2
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
n=9 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=79 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
|
3.85 Ratios
Interval 1.34 to 11.04
|
1.52 Ratios
Interval 0.92 to 2.52
|
0.96 Ratios
Interval 0.68 to 1.38
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
n=9 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=79 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
|
0.67 Ratios
Interval 0.22 to 2.08
|
0.87 Ratios
Interval 0.5 to 1.49
|
0.62 Ratios
Interval 0.42 to 0.91
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
n=9 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=79 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
|
1.08 Ratios
Interval 0.3 to 3.88
|
0.84 Ratios
Interval 0.45 to 1.54
|
0.73 Ratios
Interval 0.47 to 1.12
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
n=9 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=79 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
|
0.76 Ratios
Interval 0.24 to 2.48
|
1.05 Ratios
Interval 0.6 to 1.85
|
0.78 Ratios
Interval 0.52 to 1.16
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
|
—
|
1.09 Ratios
Interval 0.75 to 1.59
|
1.27 Ratios
Interval 0.98 to 1.64
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
|
—
|
1.45 Ratios
Interval 1.01 to 2.1
|
1.87 Ratios
Interval 1.45 to 2.41
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
|
—
|
1.16 Ratios
Interval 0.62 to 2.17
|
0.98 Ratios
Interval 0.63 to 1.52
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
|
—
|
1.37 Ratios
Interval 0.71 to 2.65
|
1.39 Ratios
Interval 0.88 to 2.21
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
|
—
|
1.16 Ratios
Interval 0.63 to 2.12
|
0.89 Ratios
Interval 0.58 to 1.35
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
|
—
|
1.5 Ratios
Interval 0.76 to 2.97
|
1.1 Ratios
Interval 0.7 to 1.72
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
|
—
|
1.88 Ratios
Interval 0.97 to 3.64
|
1.52 Ratios
Interval 0.99 to 2.35
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
|
—
|
1.27 Ratios
Interval 0.44 to 3.66
|
1.03 Ratios
Interval 0.51 to 2.05
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
|
—
|
1.05 Ratios
Interval 0.37 to 2.94
|
1.85 Ratios
Interval 0.94 to 3.64
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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).
Outcome measures
| Measure |
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from \>6 years up to \>10 years after booster vaccination).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
|
—
|
0.89 Ratios
Interval 0.39 to 2.06
|
1.04 Ratios
Interval 0.6 to 1.81
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=80 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
|
0.52 Ratios
Interval 0.35 to 0.78
|
0.26 Ratios
Interval 0.18 to 0.38
|
0.23 Ratios
Interval 0.18 to 0.3
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=80 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
|
0.48 Ratios
Interval 0.28 to 0.81
|
0.3 Ratios
Interval 0.18 to 0.49
|
0.24 Ratios
Interval 0.17 to 0.35
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=80 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
|
0.24 Ratios
Interval 0.13 to 0.43
|
0.17 Ratios
Interval 0.1 to 0.3
|
0.16 Ratios
Interval 0.11 to 0.23
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=80 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
|
0.34 Ratios
Interval 0.18 to 0.66
|
0.16 Ratios
Interval 0.09 to 0.3
|
0.19 Ratios
Interval 0.12 to 0.3
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=35 Participants
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).
|
TBE_C Group
n=39 Participants
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.
|
TBE_AC Group
n=80 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
|
0.29 Ratios
Interval 0.15 to 0.56
|
0.2 Ratios
Interval 0.11 to 0.38
|
0.2 Ratios
Interval 0.13 to 0.3
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=13 Participants
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).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
|
1.03 Ratios
Interval 0.7 to 1.52
|
0.24 Ratios
Interval 0.16 to 0.37
|
0.2 Ratios
Interval 0.15 to 0.27
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=13 Participants
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).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
|
1.36 Ratios
Interval 0.79 to 2.33
|
0.32 Ratios
Interval 0.18 to 0.57
|
0.3 Ratios
Interval 0.2 to 0.44
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=13 Participants
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).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
|
0.49 Ratios
Interval 0.23 to 1.04
|
0.26 Ratios
Interval 0.12 to 0.57
|
0.16 Ratios
Interval 0.09 to 0.27
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=13 Participants
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).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
|
0.96 Ratios
Interval 0.44 to 2.08
|
0.31 Ratios
Interval 0.14 to 0.68
|
0.22 Ratios
Interval 0.13 to 0.39
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=13 Participants
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).
|
TBE_C Group
n=12 Participants
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.
|
TBE_AC Group
n=25 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
|
0.59 Ratios
Interval 0.28 to 1.24
|
0.26 Ratios
Interval 0.12 to 0.55
|
0.14 Ratios
Interval 0.08 to 0.24
|
PRIMARY outcome
Timeframe: At Year 6Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=4 Participants
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).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
|
1.09 Ratios
Interval 0.47 to 2.55
|
0.17 Ratios
Interval 0.06 to 0.45
|
0.15 Ratios
Interval 0.08 to 0.29
|
PRIMARY outcome
Timeframe: At Year 7Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=4 Participants
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).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
|
0.77 Ratios
Interval 0.21 to 2.86
|
0.21 Ratios
Interval 0.05 to 0.96
|
0.21 Ratios
Interval 0.08 to 0.57
|
PRIMARY outcome
Timeframe: At Year 8Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=4 Participants
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).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
|
0.74 Ratios
Interval 0.2 to 2.72
|
0.14 Ratios
Interval 0.03 to 0.64
|
0.14 Ratios
Interval 0.05 to 0.38
|
PRIMARY outcome
Timeframe: At Year 9Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=4 Participants
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).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
|
1.29 Ratios
Interval 0.43 to 3.84
|
0.12 Ratios
Interval 0.03 to 0.41
|
0.26 Ratios
Interval 0.11 to 0.58
|
PRIMARY outcome
Timeframe: At Year 10Population: This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.
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.
Outcome measures
| Measure |
TBE_R Group
n=4 Participants
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).
|
TBE_C Group
n=3 Participants
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.
|
TBE_AC Group
n=7 Participants
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.
|
|---|---|---|---|
|
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
|
1.05 Ratios
Interval 0.31 to 3.49
|
0.1 Ratios
Interval 0.02 to 0.4
|
0.14 Ratios
Interval 0.06 to 0.36
|
Adverse Events
TBE_R Group
TBE_C Group
TBE_AC Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER