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Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules

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ClinicalTrials.gov Identifier: NCT01562444
Recruitment Status : Completed
First Posted : March 23, 2012
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The aim of this study is to investigate the immunogenicity response in adults up to 10 years after one booster dose. Data collected from this study will allow for greater information to prescribers who administer TBE vaccine, so that they can appropriately time the administration of booster vaccinations to individuals who received different vaccination schedules and who live in tick borne encephalitis endemic regions.

Condition or disease Intervention/treatment Phase
Tick Borne Encephalitis Other: Blood draw Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase IV, Open-label, Single-center Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules
Actual Study Start Date : March 8, 2012
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Arm Intervention/treatment
TBE_R Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to rapid (R) schedule i.e., on days 0, 7 (+3) and 21 (+7) in the parent study (V48P7) and who were administered 1 booster dose of Encepur adults either 12-18 months after R schedule completion or in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination (for those subjects boostered before V48P7E1 study start, the blood draw occurred annually starting from >6 years up to >10 years after booster vaccination).
Other: Blood draw
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)

TBE_C Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to conventional (C) schedule i.e., on days 0, 28 (+10) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
Other: Blood draw
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)

TBE_AC Group
Subjects who had previously received the Tick borne encephalitis (TBE) primary vaccination according to accelerated conventional (AC) schedule i.e., on days 0, 14 (+3) and 300 (+21) in the parent study (V48P7) and were administered 1 booster dose of Encepur adults in the first extension study, V48P7E1 (NCT00387634), were included in this group. Subjects had blood drawn annually starting from year 6 up to year 10 after booster vaccination.
Other: Blood draw
Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)




Primary Outcome Measures :
  1. Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2 [ Time Frame: At Year 6 ]
    Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.

  2. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 [ Time Frame: At Year 7 ]
    Antibody titers were measured by GSK NT assay.

  3. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 [ Time Frame: At Year 8 ]
    Antibody titers were measured by GSK NT assay.

  4. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 [ Time Frame: At Year 9 ]
    Antibody titers were measured by GSK NT assay.

  5. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 [ Time Frame: At Year 10 ]
    Antibody titers were measured by GSK NT assay.

  6. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 [ Time Frame: At Year 6 ]
    Antibody titers were measured by GSK NT assay.

  7. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 [ Time Frame: At Year 7 ]
    Antibody titers were measured by GSK NT assay.

  8. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 [ Time Frame: At Year 8 ]
    Antibody titers were measured by GSK NT assay.

  9. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 [ Time Frame: At Year 9 ]
    Antibody titers were measured by GSK NT assay.

  10. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 [ Time Frame: At Year 10 ]
    Antibody titers were measured by GSK NT assay.

  11. Evaluation of Geometric Mean Antibody Titers (GMTs) [ Time Frame: At Year 6 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate Geometric Mean Ratios (GMRs). Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  12. Evaluation of GMTs [ Time Frame: At Year 7 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  13. Evaluation of GMTs [ Time Frame: At year 8 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  14. Evaluation of GMTs [ Time Frame: At Year 9 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  15. Evaluation of GMTs [ Time Frame: At Year 10 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  16. Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines [ Time Frame: At Year 6 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  17. GMRs Calculated to Pre Booster Baselines [ Time Frame: At Year 7 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  18. GMRs Calculated to Pre Booster Baselines [ Time Frame: At Year 8 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  19. GMRs Calculated to Pre Booster Baselines [ Time Frame: At Year 9 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  20. GMRs Calculated to Pre Booster Baselines [ Time Frame: At Year 10 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  21. GMRs Calculated to Post Booster Baselines [ Time Frame: At Year 6 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  22. GMRs Calculated to Post Booster Baselines [ Time Frame: At Year 7 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  23. GMRs Calculated to Post Booster Baselines [ Time Frame: At Year 8 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  24. GMRs Calculated to Post Booster Baselines [ Time Frame: At Year 9 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  25. GMRs Calculated to Post Booster Baselines [ Time Frame: At Year 10 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  26. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups [ Time Frame: At Year 6 ]
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.

  27. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups [ Time Frame: At Year 7 ]
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.

  28. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups [ Time Frame: At Year 8 ]
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.

  29. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups [ Time Frame: At Year 9 ]
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.

  30. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups [ Time Frame: At Year 10 ]
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.

  31. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups [ Time Frame: At Year 6 ]
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.

  32. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups [ Time Frame: At Year 7 ]
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.

  33. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups [ Time Frame: At Year 8 ]
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.

  34. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups [ Time Frame: At Year 9 ]
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.

  35. Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups [ Time Frame: At Year 10 ]
    Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.

  36. Evaluation of GMTs in the Age Group of 15-49 Years [ Time Frame: At Year 6 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  37. Evaluation of GMTs in the Age Group of 15-49 Years [ Time Frame: At Year 7 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  38. Evaluation of GMTs in the Age Group of 15-49 Years [ Time Frame: At Year 8 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  39. Evaluation of GMTs in the Age Group of 15-49 Years [ Time Frame: At Year 9 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  40. Evaluation of GMTs in the Age Group of 15-49 Years [ Time Frame: At Year 10 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  41. Evaluation of GMTs in the Age Group of ≥ 50 Years [ Time Frame: At Year 6 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  42. Evaluation of GMTs in the Age Group of ≥ 50 Years [ Time Frame: At Year 7 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  43. Evaluation of GMTs in the Age Group of ≥ 50 Years [ Time Frame: At Year 8 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  44. Evaluation of GMTs in the Age Group of ≥ 50 Years [ Time Frame: At Year 9 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  45. Evaluation of GMTs in the Age Group of ≥ 50 Years [ Time Frame: At Year 10 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  46. Evaluation of GMTs in the Age Group of ≥ 60 Years [ Time Frame: At Year 6 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  47. Evaluation of GMTs in the Age Group of ≥ 60 Years [ Time Frame: At Year 7 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  48. Evaluation of GMTs in the Age Group of ≥ 60 Years [ Time Frame: At Year 8 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  49. Evaluation of GMTs in the Age Group of ≥ 60 Years [ Time Frame: At Year 9 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  50. Evaluation of GMTs in the Age Group of ≥ 60 Years [ Time Frame: At Year 10 ]
    GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  51. GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years [ Time Frame: At Year 6 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  52. GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years [ Time Frame: At Year 7 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  53. GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years [ Time Frame: At Year 8 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  54. GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years [ Time Frame: At Year 9 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  55. GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years [ Time Frame: At Year 10 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  56. GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years [ Time Frame: At Year 6 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  57. GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years [ Time Frame: At Year 7 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  58. GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years [ Time Frame: At Year 8 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  59. GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years [ Time Frame: At Year 9 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  60. GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years [ Time Frame: At Year 10 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  61. GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years [ Time Frame: At Year 6 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  62. GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years [ Time Frame: At Year 7 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  63. GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years [ Time Frame: At Year 8 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  64. GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years [ Time Frame: At Year 9 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  65. GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years [ Time Frame: At Year 10 ]
    GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).

  66. GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years [ Time Frame: At Year 6 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  67. GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years [ Time Frame: At Year 7 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  68. GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years [ Time Frame: At Year 8 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  69. GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years [ Time Frame: At Year 9 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  70. GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years [ Time Frame: At Year 10 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  71. GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years [ Time Frame: At Year 6 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  72. GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years [ Time Frame: At Year 7 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  73. GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years [ Time Frame: At Year 8 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  74. GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years [ Time Frame: At Year 9 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  75. GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years [ Time Frame: At Year 10 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  76. GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years [ Time Frame: At Year 6 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  77. GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years [ Time Frame: At Year 7 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  78. GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years [ Time Frame: At Year 8 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  79. GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years [ Time Frame: At Year 9 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.

  80. GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years [ Time Frame: At Year 10 ]
    GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who have completed prior study - V48P7E1.

Exclusion Criteria:

  • Subjects whose antibody responses to booster vaccine received in the parent study fell below protective levels, subjects who have been exposed to TBE or flavivirus vaccine, subjects with immunosuppression.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562444


Locations
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Czechia
GSK Investigational Site
Hradec Kralove, Czechia, 50002
Sponsors and Collaborators
GlaxoSmithKline
Novartis Vaccines
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01562444     History of Changes
Other Study ID Numbers: 205335
2011-003255-19 ( EudraCT Number )
V48P7E2 ( Other Identifier: Novartis )
First Posted: March 23, 2012    Key Record Dates
Results First Posted: August 31, 2018
Last Update Posted: August 31, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Long term immunogenicity study
Additional relevant MeSH terms:
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Encephalitis, Tick-Borne
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs