Virus Diseases
Conditions
Keywords
Encepur, Adults, Long term immunogenicity, Tick-borne Encephalitis vaccine, Booster
Brief summary
The purpose of this study is to continue the evaluation of antibody persistence through 11 to 15 years after first booster with Tick-Borne Encephalitis (TBE) vaccine. This study will further investigate the booster response in subjects who will receive their second booster dose\* in this study. \* Any booster given in this study will be the second that the subject has received (with regard to the follow-up of the previous study).
Interventions
BIOLOGICALEncepur Adults
One dose of the vaccine can be administered at any one unscheduled visit depending on the detection of NT below 10. It will be administered intramuscularly into the non-dominant deltoid.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All subjects will come to the yearly scheduled blood draw visit for investigation of 11 to 15 year persistence of Neutralization Test (NT) titres. Subjects who have an NT titre below 10 at one of the scheduled visits will receive a second booster dose 6 months after this visit at an unscheduled visit. Subsequent data of these subjects will be analysed separately in a subgroup.
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for all subjects: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performance of any study specific procedure. * Subjects who have participated in study V48P7E2 (NCT01562444) and who received in the parent V48P7 study one of the following schedules: rapid, conventional, or accelerated conventional and a booster vaccination in study V48P7E1 (NCT00387634) or before study V48P7E1 (NCT00387634) (only rapid schedule). Additional inclusion criteria for subjects who will need a second booster dose: * Healthy subjects as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. * Female subjects of childbearing potential can receive the booster vaccine in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception for 2 months after booster administration.
Exclusion criteria
Each subject must not be: * Unwilling or unable to give written informed consent to participate in the study. * Perceived to be unreliable or unavailable to complete the study. Each subject must not have: * Clinical conditions representing a contraindication to blood draws. * Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. * Received an investigational or non-registered medicinal product within 30 days prior to informed consent. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. * Levels of NT\<10 in V48P7E2 (NCT01562444) study. * Previous vaccination against TBE or other Flavivirus diseases with other TBE and Flavivirus vaccines (e.g. Yellow fever vaccine, Dengue fever vaccine, Japanese encephalitis vaccine) before, during and after completion of the V48P7E2 (NCT01562444) and before starting TBEV POLYGELINE FREE-025 EXT 21 study. * Primary immunization with TBE vaccine in the parent study V48P7 according to the modified conventional (MC) schedule. * History of confirmed TBE infection. * Known exposure to other Flaviviruses. Each subject who will receive the second booster vaccination in this study additionally to the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | At Year 15 | 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. |
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15 | At Year 15 | 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. |
| Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | At Year 11 | 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. |
| Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | At Year 12 | 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. |
| Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | At Year 13 | 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. |
| Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | At Year 14 | 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. |
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11 | At Year 11 | 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. |
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12 | At Year 12 | 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. |
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13 | At Year 13 | 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. |
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14 | At Year 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Titers (GMTs) as Measured by GSK Biologicals' NT, Overall and by Study Group | At 21 days after the booster vaccination | Immunogenicity was planned to be measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination. |
| Geometric Mean Ratios (GMRs) Blood Draw After/Before Booster as Measured by GSK Biologicals' NT, Overall and by Study Group | At 21 days after the booster vaccination | Immunogenicity was planned to be measured in terms of GMRs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination. |
| 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 | From Year 1 up to Year 15 | Immunogenicity was measured in terms of percentage of participants with TBE Neutralizing Antibody Titers \>= 10 from Year 1 to Year 15. |
| Number of Participants With Serious Adverse Events (SAEs) | From Day 0 to Day 21 after booster vaccination | 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. |
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 2 and Equal to or Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group | At 21 days after the booster vaccination | 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. |
Countries
Czechia
Participant flow
Recruitment details
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.
Pre-assignment details
No participant received vaccination in study V48P7E2 (NCT01562444).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 43 |
| 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. | 101 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Other | 2 | 0 | 0 |
| Overall Study | Serious Adverse Event | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group | Total |
|---|---|---|---|---|
| Age, Customized | 47.0 Years STANDARD_DEVIATION 14.1 | 48.8 Years STANDARD_DEVIATION 15.3 | 48.1 Years STANDARD_DEVIATION 14.5 | 48.0 Years STANDARD_DEVIATION 14.5 |
| Race/Ethnicity, Customized WHITE | 50 Participants | 43 Participants | 101 Participants | 194 Participants |
| Sex: Female, Male Female | 31 Participants | 22 Participants | 52 Participants | 105 Participants |
| Sex: Female, Male Male | 19 Participants | 21 Participants | 49 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 50 | 0 / 43 | 1 / 101 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 1 / 50 | 0 / 43 | 1 / 101 |
Outcome results
Primary
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11
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.
Time frame: At Year 11
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | >=50 Years of Age | 129.6 Titers |
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | 25 to 49 Years of Age | 368.8 Titers |
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | >=60 Years of Age | 127.5 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | >=50 Years of Age | 177.4 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | 25 to 49 Years of Age | 301.5 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | >=60 Years of Age | 160.2 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | 25 to 49 Years of Age | 235.2 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | >=60 Years of Age | 103.0 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | >=50 Years of Age | 128.1 Titers |
Primary
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12
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.
Time frame: At Year 12
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | >=50 Years of Age | 154.5 Titers |
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | 25 to 49 Years of Age | 323.7 Titers |
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | >=60 Years of Age | 133.6 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | >=50 Years of Age | 205.8 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | 25 to 49 Years of Age | 334.6 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | >=60 Years of Age | 190.8 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | 25 to 49 Years of Age | 264.3 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | >=60 Years of Age | 141.0 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | >=50 Years of Age | 158.2 Titers |
Primary
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13
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.
Time frame: At Year 13
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | >=50 Years of Age | 98.3 Titers |
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | 25 to 49 Years of Age | 196.9 Titers |
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | >=60 Years of Age | 93.5 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | >=50 Years of Age | 132.1 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | 25 to 49 Years of Age | 238.4 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | >=60 Years of Age | 114.8 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | 25 to 49 Years of Age | 172.8 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | >=60 Years of Age | 96.9 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | >=50 Years of Age | 110.9 Titers |
Primary
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14
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.
Time frame: At Year 14
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | >=60 Years of Age | 139.4 Titers |
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | >=50 Years of Age | 147.5 Titers |
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | 25 to 49 Years of Age | 299.7 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | >=50 Years of Age | 169.7 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | 25 to 49 Years of Age | 299.1 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | >=60 Years of Age | 149.9 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | 25 to 49 Years of Age | 248.2 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | >=60 Years of Age | 117.9 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | >=50 Years of Age | 131.1 Titers |
Primary
Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15
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.
Time frame: At Year 15
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | >=50 Years of Age | 98.9 Titers |
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | 25 to 49 Years of Age | 217.6 Titers |
| Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | >=60 Years of Age | 114.1 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | >=50 Years of Age | 157.0 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | 25 to 49 Years of Age | 281.6 Titers |
| Accelerated/Rapid Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | >=60 Years of Age | 158.1 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | 25 to 49 Years of Age | 183.9 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | >=60 Years of Age | 90.7 Titers |
| Accelerated Conventional Group | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | >=50 Years of Age | 103.3 Titers |
Primary
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11
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.
Time frame: At Year 11
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11 | 100 Percentage of participants |
| Accelerated/Rapid Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11 | 100 Percentage of participants |
| Accelerated Conventional Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11 | 99.0 Percentage of participants |
Primary
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12
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.
Time frame: At Year 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12 | 98.0 Percentage of participants |
| Accelerated/Rapid Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12 | 100 Percentage of participants |
| Accelerated Conventional Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12 | 99.0 Percentage of participants |
Primary
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13
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.
Time frame: At Year 13
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13 | 95.9 Percentage of participants |
| Accelerated/Rapid Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13 | 100 Percentage of participants |
| Accelerated Conventional Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13 | 99.0 Percentage of participants |
Primary
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14
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.
Time frame: At Year 14
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14 | 95.9 Percentage of participants |
| Accelerated/Rapid Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14 | 100 Percentage of participants |
| Accelerated Conventional Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14 | 99.0 Percentage of participants |
Primary
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15
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.
Time frame: At Year 15
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15 | 95.8 Percentage of participants |
| Accelerated/Rapid Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15 | 100 Percentage of participants |
| Accelerated Conventional Group | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15 | 99.0 Percentage of participants |
Secondary
Geometric Mean Antibody Titers (GMTs) as Measured by GSK Biologicals' NT, Overall and by Study Group
Immunogenicity was planned to be measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.
Time frame: At 21 days after the booster vaccination
Population: 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.
Secondary
Geometric Mean Ratios (GMRs) Blood Draw After/Before Booster as Measured by GSK Biologicals' NT, Overall and by Study Group
Immunogenicity was planned to be measured in terms of GMRs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.
Time frame: At 21 days after the booster vaccination
Population: 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.
Secondary
Number of Participants With Serious Adverse Events (SAEs)
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.
Time frame: From Day 0 to Day 21 after booster vaccination
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Group | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
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
Immunogenicity was measured in terms of percentage of participants with TBE Neutralizing Antibody Titers \>= 10 from Year 1 to Year 15.
Time frame: From Year 1 up to Year 15
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Conventional Group | 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 |
| Accelerated/Rapid Group | 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 |
| Accelerated/Rapid Group | 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 | 97.6 Percentage of participants |
| Accelerated/Rapid Group | 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 |
| Accelerated/Rapid Group | 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 |
| Accelerated/Rapid Group | 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 |
| Accelerated/Rapid Group | 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 |
| Accelerated/Rapid Group | 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 |
| Accelerated/Rapid Group | 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 |
| Accelerated/Rapid Group | 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 |
| Accelerated/Rapid Group | 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 | 100 Percentage of participants |
| Accelerated/Rapid Group | 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 | 100 Percentage of participants |
| Accelerated/Rapid Group | 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 | 100 Percentage of participants |
| Accelerated/Rapid Group | 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 | 100 Percentage of participants |
| Accelerated/Rapid Group | 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 |
| Accelerated/Rapid Group | 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 |
| Accelerated Conventional Group | 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 |
| Accelerated Conventional Group | 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 | 99.0 Percentage of participants |
| Accelerated Conventional Group | 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 |
| Accelerated Conventional Group | 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 |
| Accelerated Conventional Group | 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 | 99.0 Percentage of participants |
| Accelerated Conventional Group | 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 |
| Accelerated Conventional Group | 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 |
| Accelerated Conventional Group | 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 | 99.0 Percentage of participants |
| Accelerated Conventional Group | 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 |
| Accelerated Conventional Group | 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 |
| Accelerated Conventional Group | 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 | 99.0 Percentage of participants |
| Accelerated Conventional Group | 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 |
| Accelerated Conventional Group | 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 |
| Accelerated Conventional Group | 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 | 99.0 Percentage of participants |
| Accelerated Conventional Group | 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 |
Secondary
Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 2 and Equal to or Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group
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.
Time frame: At 21 days after the booster vaccination
Population: 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.