Trial Outcomes & Findings for The Aim of This Study is to Investigate the Persistence of Antibody Response in Adults up to 15 Years After One Booster Dose of GlaxoSmithKline (GSK) Biologicals' Encepur Adults Vaccine (NCT NCT03294135)
NCT ID: NCT03294135
Last Updated: 2024-03-28
Results Overview
Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
194 participants
Primary outcome timeframe
At Year 11
Results posted on
2024-03-28
Participant Flow
194 subjects, who participated in study V48P7E2(NCT01562444), received in a parent V48P7 study one of the following primary schedules: rapid(R), conventional(C), or accelerated conventional(AC), who received a booster dose in study V48P7E1(NCT00387634) or before study V48P7E1(only R-schedule), and agreed to participate in this study, were enrolled.
No participant received vaccination in study V48P7E2 (NCT01562444).
Participant milestones
| Measure |
Conventional Group
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
43
|
101
|
|
Overall Study
COMPLETED
|
46
|
43
|
99
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
2
|
Reasons for withdrawal
| Measure |
Conventional Group
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Overall Study
Serious Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Other
|
2
|
0
|
0
|
Baseline Characteristics
The Aim of This Study is to Investigate the Persistence of Antibody Response in Adults up to 15 Years After One Booster Dose of GlaxoSmithKline (GSK) Biologicals' Encepur Adults Vaccine
Baseline characteristics by cohort
| Measure |
Conventional Group
n=50 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=101 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
47.0 Years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
48.8 Years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
48.1 Years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
48.0 Years
STANDARD_DEVIATION 14.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Year 11Population: The analysis was performed on the Per Protocol set-1 (PPS-1) which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.
Outcome measures
| Measure |
Conventional Group
n=48 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=101 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11
|
100 Percentage of participants
Interval 92.6 to 100.0
|
100 Percentage of participants
Interval 91.8 to 100.0
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
PRIMARY outcome
Timeframe: At Year 12Population: The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.
Outcome measures
| Measure |
Conventional Group
n=50 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=101 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12
|
98.0 Percentage of participants
Interval 89.4 to 99.9
|
100 Percentage of participants
Interval 91.8 to 100.0
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
PRIMARY outcome
Timeframe: At Year 13Population: The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.
Outcome measures
| Measure |
Conventional Group
n=49 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=101 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13
|
95.9 Percentage of participants
Interval 86.0 to 99.5
|
100 Percentage of participants
Interval 91.8 to 100.0
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
PRIMARY outcome
Timeframe: At Year 14Population: The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.
Outcome measures
| Measure |
Conventional Group
n=49 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=101 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14
|
95.9 Percentage of participants
Interval 86.0 to 99.5
|
100 Percentage of participants
Interval 91.8 to 100.0
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
PRIMARY outcome
Timeframe: At Year 15Population: The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers \>= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period.
Outcome measures
| Measure |
Conventional Group
n=48 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=100 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15
|
95.8 Percentage of participants
Interval 85.7 to 99.5
|
100 Percentage of participants
Interval 91.8 to 100.0
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
PRIMARY outcome
Timeframe: At Year 11Population: The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 11. GMTs were assessed for following age subgroups: 25 to 49 years, equal to or above (\>=) 50 years and \>= 60 years.
Outcome measures
| Measure |
Conventional Group
n=48 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=101 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11
25 to 49 Years of Age
|
368.8 Titers
Interval 208.9 to 651.1
|
301.5 Titers
Interval 168.7 to 538.7
|
235.2 Titers
Interval 161.6 to 342.3
|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11
>=50 Years of Age
|
129.6 Titers
Interval 76.7 to 218.8
|
177.4 Titers
Interval 100.0 to 314.9
|
128.1 Titers
Interval 87.7 to 187.0
|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11
>=60 Years of Age
|
127.5 Titers
Interval 61.3 to 265.4
|
160.2 Titers
Interval 79.2 to 324.0
|
103.0 Titers
Interval 62.6 to 169.5
|
PRIMARY outcome
Timeframe: At Year 12Population: The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 12. GMTs were assessed for following age subgroups: 25 to 49 years, \>= 50 years and \>= 60 years.
Outcome measures
| Measure |
Conventional Group
n=50 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=101 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12
25 to 49 Years of Age
|
323.7 Titers
Interval 185.0 to 566.3
|
334.6 Titers
Interval 184.6 to 606.4
|
264.3 Titers
Interval 179.9 to 388.3
|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12
>=50 Years of Age
|
154.5 Titers
Interval 87.6 to 272.4
|
205.8 Titers
Interval 110.6 to 383.0
|
158.2 Titers
Interval 105.0 to 238.3
|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12
>=60 Years of Age
|
133.6 Titers
Interval 62.5 to 285.6
|
190.8 Titers
Interval 92.0 to 395.9
|
141.0 Titers
Interval 84.2 to 236.3
|
PRIMARY outcome
Timeframe: At Year 13Population: The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 13. GMTs were assessed for following age subgroups: 25 to 49 years, \>= 50 years and \>= 60 years.
Outcome measures
| Measure |
Conventional Group
n=49 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=101 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13
25 to 49 Years of Age
|
196.9 Titers
Interval 112.2 to 345.6
|
238.4 Titers
Interval 131.1 to 433.6
|
172.8 Titers
Interval 117.3 to 254.3
|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13
>=50 Years of Age
|
98.3 Titers
Interval 56.6 to 170.9
|
132.1 Titers
Interval 73.0 to 238.9
|
110.9 Titers
Interval 75.0 to 164.0
|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13
>=60 Years of Age
|
93.5 Titers
Interval 44.7 to 195.6
|
114.8 Titers
Interval 56.5 to 233.4
|
96.9 Titers
Interval 58.7 to 160.0
|
PRIMARY outcome
Timeframe: At Year 14Population: The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 14. GMTs were assessed for following age subgroups: 25 to 49 years, \>= 50 years and \>= 60 years.
Outcome measures
| Measure |
Conventional Group
n=49 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=101 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14
25 to 49 Years of Age
|
299.7 Titers
Interval 164.2 to 547.0
|
299.1 Titers
Interval 157.8 to 567.1
|
248.2 Titers
Interval 164.1 to 375.4
|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14
>=50 Years of Age
|
147.5 Titers
Interval 81.2 to 268.0
|
169.7 Titers
Interval 89.5 to 321.8
|
131.1 Titers
Interval 86.0 to 200.0
|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14
>=60 Years of Age
|
139.4 Titers
Interval 67.2 to 289.3
|
149.9 Titers
Interval 74.3 to 302.4
|
117.9 Titers
Interval 71.8 to 193.7
|
PRIMARY outcome
Timeframe: At Year 15Population: The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation.
Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 15. GMTs were assessed for following age subgroups: 25 to 49 years, \>= 50 years and \>= 60 years.
Outcome measures
| Measure |
Conventional Group
n=48 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=100 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15
25 to 49 Years of Age
|
217.6 Titers
Interval 125.2 to 378.2
|
281.6 Titers
Interval 156.5 to 506.9
|
183.9 Titers
Interval 125.7 to 268.9
|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15
>=50 Years of Age
|
98.9 Titers
Interval 54.4 to 180.0
|
157.0 Titers
Interval 83.8 to 294.1
|
103.3 Titers
Interval 67.9 to 156.9
|
|
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15
>=60 Years of Age
|
114.1 Titers
Interval 52.5 to 247.8
|
158.1 Titers
Interval 77.5 to 322.7
|
90.7 Titers
Interval 54.2 to 151.7
|
SECONDARY outcome
Timeframe: At 21 days after the booster vaccinationPopulation: The analysis was planned to be performed on the PPS-2 which consisted of all participants who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed.
Immunogenicity was planned to be measured in terms of percentage of participants with TBE Neutralizing Antibody Titers \>= 2 and \>= 10 at 21 days after the booster vaccination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 21 days after the booster vaccinationPopulation: The analysis was planned to be performed on the PPS-2 which consisted of all subjects who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed.
Immunogenicity was planned to be measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 21 days after the booster vaccinationPopulation: The analysis was planned to be performed on the PPS-2 which consisted of all subjects who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed.
Immunogenicity was planned to be measured in terms of GMRs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Year 1 up to Year 15Population: The analysis was performed on the set of subjects who completed the entire 15-year follow-up with no protocol deviations related to the persistence analysis. Here, 'number analyzed' = participants with available data for each specified category.
Immunogenicity was measured in terms of percentage of participants with TBE Neutralizing Antibody Titers \>= 10 from Year 1 to Year 15.
Outcome measures
| Measure |
Conventional Group
n=48 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=100 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 1
|
100 Percentage of participants
Interval 92.5 to 100.0
|
100 Percentage of participants
Interval 91.6 to 100.0
|
100 Percentage of participants
Interval 96.4 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 2
|
100 Percentage of participants
Interval 92.6 to 100.0
|
100 Percentage of participants
Interval 91.6 to 100.0
|
100 Percentage of participants
Interval 96.3 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 3
|
100 Percentage of participants
Interval 92.6 to 100.0
|
100 Percentage of participants
Interval 91.6 to 100.0
|
100 Percentage of participants
Interval 96.4 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 4
|
100 Percentage of participants
Interval 92.3 to 100.0
|
97.6 Percentage of participants
Interval 87.1 to 99.9
|
100 Percentage of participants
Interval 96.4 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 5
|
100 Percentage of participants
Interval 92.6 to 100.0
|
100 Percentage of participants
Interval 91.8 to 100.0
|
100 Percentage of participants
Interval 96.4 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 6
|
100 Percentage of participants
Interval 92.6 to 100.0
|
100 Percentage of participants
Interval 91.8 to 100.0
|
100 Percentage of participants
Interval 96.4 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 7
|
100 Percentage of participants
Interval 92.6 to 100.0
|
100 Percentage of participants
Interval 91.8 to 100.0
|
100 Percentage of participants
Interval 96.3 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 8
|
100 Percentage of participants
Interval 92.5 to 100.0
|
100 Percentage of participants
Interval 91.6 to 100.0
|
100 Percentage of participants
Interval 96.3 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 9
|
100 Percentage of participants
Interval 92.1 to 100.0
|
100 Percentage of participants
Interval 91.6 to 100.0
|
100 Percentage of participants
Interval 96.3 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 10
|
100 Percentage of participants
Interval 92.3 to 100.0
|
100 Percentage of participants
Interval 91.6 to 100.0
|
100 Percentage of participants
Interval 96.3 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 11
|
100 Percentage of participants
Interval 92.3 to 100.0
|
100 Percentage of participants
Interval 91.8 to 100.0
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 12
|
97.9 Percentage of participants
Interval 88.9 to 99.9
|
100 Percentage of participants
Interval 91.8 to 100.0
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 13
|
95.8 Percentage of participants
Interval 85.7 to 99.5
|
100 Percentage of participants
Interval 91.8 to 100.0
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 14
|
95.8 Percentage of participants
Interval 85.7 to 99.5
|
100 Percentage of participants
Interval 91.8 to 100.0
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
|
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
Year 15
|
95.8 Percentage of participants
Interval 85.7 to 99.5
|
100 Percentage of participants
Interval 91.8 to 100.0
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
SECONDARY outcome
Timeframe: From Day 0 to Day 21 after booster vaccinationPopulation: The analysis was performed on the Safety population which included all subjects who received a booster vaccination in this study. Only one participant (from the Conventional Group) received a booster dose.
SAEs are defined as any untoward medical occurrence that results in death, is life- threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Conventional Group
n=1 Participants
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
—
|
—
|
Adverse Events
Conventional Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Accelerated/Rapid Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Accelerated Conventional Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Conventional Group
n=50 participants at risk
Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10.
|
Accelerated/Rapid Group
n=43 participants at risk
Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
Accelerated Conventional Group
n=101 participants at risk
Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to glioblastoma
|
2.0%
1/50 • Number of events 1 • Serious adverse events that led to withdrawal or were related to study vaccination were collected throughout the study period (Year 11 to Year 15). Other serious adverse events were collected only after the booster vaccination administration (Day 0-Day 21).
Other adverse events were not collected as per protocol.
|
0.00%
0/43 • Serious adverse events that led to withdrawal or were related to study vaccination were collected throughout the study period (Year 11 to Year 15). Other serious adverse events were collected only after the booster vaccination administration (Day 0-Day 21).
Other adverse events were not collected as per protocol.
|
0.00%
0/101 • Serious adverse events that led to withdrawal or were related to study vaccination were collected throughout the study period (Year 11 to Year 15). Other serious adverse events were collected only after the booster vaccination administration (Day 0-Day 21).
Other adverse events were not collected as per protocol.
|
|
Infections and infestations
Death due to primary COVID-19 pneumonia
|
0.00%
0/50 • Serious adverse events that led to withdrawal or were related to study vaccination were collected throughout the study period (Year 11 to Year 15). Other serious adverse events were collected only after the booster vaccination administration (Day 0-Day 21).
Other adverse events were not collected as per protocol.
|
0.00%
0/43 • Serious adverse events that led to withdrawal or were related to study vaccination were collected throughout the study period (Year 11 to Year 15). Other serious adverse events were collected only after the booster vaccination administration (Day 0-Day 21).
Other adverse events were not collected as per protocol.
|
0.99%
1/101 • Number of events 1 • Serious adverse events that led to withdrawal or were related to study vaccination were collected throughout the study period (Year 11 to Year 15). Other serious adverse events were collected only after the booster vaccination administration (Day 0-Day 21).
Other adverse events were not collected as per protocol.
|
Other adverse events
Adverse event data not reported
Additional Information
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