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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
194
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.
GSK Investigational Site
Hradec Králové, Czechia
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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