Skip to main content
OpenTrials
Completed

NCT Number: NCT01562444

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tick Borne Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Tick-Borne Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Tick-Borne Diseases Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site

Hradec Králové, 50002, Czechia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Draw

Other

Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 23, 2012
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.