A Phase 4 interventional study of Encepur Adults in Virus Diseases, sponsored by GlaxoSmithKline. Completed at 1 site in Czechia. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Prevention
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).
Inclusion Criteria:
Inclusion criteria for all subjects:
Additional inclusion criteria for subjects who will need a second booster dose:
Exclusion Criteria:
Each subject must not be:
Each subject must not have:
Each subject who will receive the second booster vaccination in this study additionally to the exclusion criteria above must not have:
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.
Biological: Encepur Adults
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.
Biological: Encepur Adults
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.
Biological: Encepur 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.
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
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.
| Milestone | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| Started | 50 | 43 | 101 |
| Completed | 46 | 43 | 99 |
| Not completed | 4 | 0 | 2 |
| Withdrew: Serious adverse event | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Other | 2 | 0 | 0 |
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 | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11 | 100 (92.6 to 100) | 100 (91.8 to 100) | 99.0 (94.6 to 100) |
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 | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12 | 98.0 (89.4 to 99.9) | 100 (91.8 to 100) | 99.0 (94.6 to 100) |
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 | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13 | 95.9 (86.0 to 99.5) | 100 (91.8 to 100) | 99.0 (94.6 to 100) |
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 | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14 | 95.9 (86.0 to 99.5) | 100 (91.8 to 100) | 99.0 (94.6 to 100) |
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 | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15 | 95.8 (85.7 to 99.5) | 100 (91.8 to 100) | 99.0 (94.6 to 100) |
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.
| Titers | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| 25 to 49 Years of Age | 368.8 (208.9 to 651.1) | 301.5 (168.7 to 538.7) | 235.2 (161.6 to 342.3) |
| >=50 Years of Age | 129.6 (76.7 to 218.8) | 177.4 (100.0 to 314.9) | 128.1 (87.7 to 187.0) |
| >=60 Years of Age | 127.5 (61.3 to 265.4) | 160.2 (79.2 to 324.0) | 103.0 (62.6 to 169.5) |
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.
| Titers | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| 25 to 49 Years of Age | 323.7 (185.0 to 566.3) | 334.6 (184.6 to 606.4) | 264.3 (179.9 to 388.3) |
| >=50 Years of Age | 154.5 (87.6 to 272.4) | 205.8 (110.6 to 383.0) | 158.2 (105.0 to 238.3) |
| >=60 Years of Age | 133.6 (62.5 to 285.6) | 190.8 (92.0 to 395.9) | 141.0 (84.2 to 236.3) |
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.
| Titers | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| 25 to 49 Years of Age | 196.9 (112.2 to 345.6) | 238.4 (131.1 to 433.6) | 172.8 (117.3 to 254.3) |
| >=50 Years of Age | 98.3 (56.6 to 170.9) | 132.1 (73.0 to 238.9) | 110.9 (75.0 to 164.0) |
| >=60 Years of Age | 93.5 (44.7 to 195.6) | 114.8 (56.5 to 233.4) | 96.9 (58.7 to 160.0) |
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.
| Titers | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| 25 to 49 Years of Age | 299.7 (164.2 to 547.0) | 299.1 (157.8 to 567.1) | 248.2 (164.1 to 375.4) |
| >=50 Years of Age | 147.5 (81.2 to 268.0) | 169.7 (89.5 to 321.8) | 131.1 (86.0 to 200.0) |
| >=60 Years of Age | 139.4 (67.2 to 289.3) | 149.9 (74.3 to 302.4) | 117.9 (71.8 to 193.7) |
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.
| Titers | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| 25 to 49 Years of Age | 217.6 (125.2 to 378.2) | 281.6 (156.5 to 506.9) | 183.9 (125.7 to 268.9) |
| >=50 Years of Age | 98.9 (54.4 to 180.0) | 157.0 (83.8 to 294.1) | 103.3 (67.9 to 156.9) |
| >=60 Years of Age | 114.1 (52.5 to 247.8) | 158.1 (77.5 to 322.7) | 90.7 (54.2 to 151.7) |
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.
No measurements were reported for this outcome.
Immunogenicity was planned to be measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.
No measurements were reported for this outcome.
Immunogenicity was planned to be measured in terms of GMRs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination.
No measurements were reported for this outcome.
Immunogenicity was measured in terms of percentage of participants with TBE Neutralizing Antibody Titers \>= 10 from Year 1 to Year 15.
| Percentage of participants | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| Year 1 | 100 (92.5 to 100) | 100 (91.6 to 100) | 100 (96.4 to 100) |
| Year 2 | 100 (92.6 to 100) | 100 (91.6 to 100) | 100 (96.3 to 100) |
| Year 3 | 100 (92.6 to 100) | 100 (91.6 to 100) | 100 (96.4 to 100) |
| Year 4 | 100 (92.3 to 100) | 97.6 (87.1 to 99.9) | 100 (96.4 to 100) |
| Year 5 | 100 (92.6 to 100) | 100 (91.8 to 100) | 100 (96.4 to 100) |
| Year 6 | 100 (92.6 to 100) | 100 (91.8 to 100) | 100 (96.4 to 100) |
| Year 7 | 100 (92.6 to 100) | 100 (91.8 to 100) | 100 (96.3 to 100) |
| Year 8 | 100 (92.5 to 100) | 100 (91.6 to 100) | 100 (96.3 to 100) |
| Year 9 | 100 (92.1 to 100) | 100 (91.6 to 100) | 100 (96.3 to 100) |
| Year 10 | 100 (92.3 to 100) | 100 (91.6 to 100) | 100 (96.3 to 100) |
| Year 11 | 100 (92.3 to 100) | 100 (91.8 to 100) | 99.0 (94.6 to 100) |
| Year 12 | 97.9 (88.9 to 99.9) | 100 (91.8 to 100) | 99.0 (94.6 to 100) |
| Year 13 | 95.8 (85.7 to 99.5) | 100 (91.8 to 100) | 99.0 (94.6 to 100) |
| Year 14 | 95.8 (85.7 to 99.5) | 100 (91.8 to 100) | 99.0 (94.6 to 100) |
| Year 15 | 95.8 (85.7 to 99.5) | 100 (91.8 to 100) | 99.0 (94.6 to 100) |
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.
| Participants | Conventional Group |
|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 0 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional Group | 1/50 (2%) | 1/50 (2%) | — |
| Accelerated/Rapid Group | 0/43 (0%) | 0/43 (0%) | — |
| Accelerated Conventional Group | 1/101 (1%) | 1/101 (1%) | — |
| Event | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group |
|---|---|---|---|
| Death due to glioblastomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/50 | 0/43 | 0/101 |
| Death due to primary COVID-19 pneumoniaInfections and infestations | 0/50 | 0/43 | 1/101 |
| Age, Customized(Years) | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group | Total |
|---|---|---|---|---|
| Mean | 47.0 ± 14.1 | 48.8 ± 15.3 | 48.1 ± 14.5 | 48.0 ± 14.5 |
| Sex: Female, Male(Participants) | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group | Total |
|---|---|---|---|---|
| Female | 31 | 22 | 52 | 105 |
| Male | 19 | 21 | 49 | 89 |
| Race/Ethnicity, Customized(Participants) | Conventional Group | Accelerated/Rapid Group | Accelerated Conventional Group | Total |
|---|---|---|---|---|
| WHITE | 50 | 43 | 101 | 194 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline