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

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

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.

Study Overview

• Status: Completed
• Conditions: Virus Diseases; Tick Borne Encephalitis
• Intervention / Treatment: Other: Blood draw

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czechia
  • Hradec Kralove, Czechia, 50002
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)
Other: 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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2	Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.	At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2	Antibody titers were measured by GSK NT assay.	At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2	Antibody titers were measured by GSK NT assay.	At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2	Antibody titers were measured by GSK NT assay.	At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2	Antibody titers were measured by GSK NT assay.	At Year 10
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10	Antibody titers were measured by GSK NT assay.	At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10	Antibody titers were measured by GSK NT assay.	At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10	Antibody titers were measured by GSK NT assay.	At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10	Antibody titers were measured by GSK NT assay.	At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10	Antibody titers were measured by GSK NT assay.	At Year 10
Evaluation of Geometric Mean Antibody Titers (GMTs)	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.	At Year 6
Evaluation of GMTs	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.	At Year 7
Evaluation of GMTs	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.	At year 8
Evaluation of GMTs	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.	At Year 9
Evaluation of GMTs	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.	At Year 10
Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines	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).	At Year 6
GMRs Calculated to Pre Booster Baselines	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).	At Year 7
GMRs Calculated to Pre Booster Baselines	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).	At Year 8
GMRs Calculated to Pre Booster Baselines	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).	At Year 9
GMRs Calculated to Pre Booster Baselines	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).	At Year 10
GMRs Calculated to Post Booster Baselines	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.	At Year 6
GMRs Calculated to Post Booster Baselines	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.	At Year 7
GMRs Calculated to Post Booster Baselines	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.	At Year 8
GMRs Calculated to Post Booster Baselines	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.	At Year 9
GMRs Calculated to Post Booster Baselines	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.	At Year 10
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups	Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.	At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups	Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.	At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups	Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.	At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups	Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.	At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups	Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.	At Year 10
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups	Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.	At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups	Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.	At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups	Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.	At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups	Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.	At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups	Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.	At Year 10
Evaluation of GMTs in the Age Group of 15-49 Years	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.	At Year 6
Evaluation of GMTs in the Age Group of 15-49 Years	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.	At Year 7
Evaluation of GMTs in the Age Group of 15-49 Years	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.	At Year 8
Evaluation of GMTs in the Age Group of 15-49 Years	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.	At Year 9
Evaluation of GMTs in the Age Group of 15-49 Years	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.	At Year 10
Evaluation of GMTs in the Age Group of ≥ 50 Years	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.	At Year 6
Evaluation of GMTs in the Age Group of ≥ 50 Years	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.	At Year 7
Evaluation of GMTs in the Age Group of ≥ 50 Years	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.	At Year 8
Evaluation of GMTs in the Age Group of ≥ 50 Years	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.	At Year 9
Evaluation of GMTs in the Age Group of ≥ 50 Years	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.	At Year 10
Evaluation of GMTs in the Age Group of ≥ 60 Years	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.	At Year 6
Evaluation of GMTs in the Age Group of ≥ 60 Years	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.	At Year 7
Evaluation of GMTs in the Age Group of ≥ 60 Years	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.	At Year 8
Evaluation of GMTs in the Age Group of ≥ 60 Years	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.	At Year 9
Evaluation of GMTs in the Age Group of ≥ 60 Years	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.	At Year 10
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years	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).	At Year 6
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years	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).	At Year 7
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years	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).	At Year 8
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years	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).	At Year 9
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years	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).	At Year 10
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years	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).	At Year 6
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years	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).	At Year 7
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years	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).	At Year 8
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years	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).	At Year 9
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years	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).	At Year 10
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years	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).	At Year 6
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years	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).	At Year 7
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years	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).	At Year 8
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years	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).	At Year 9
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years	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).	At Year 10
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years	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.	At Year 6
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years	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.	At Year 7
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years	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.	At Year 8
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years	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.	At Year 9
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years	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.	At Year 10
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years	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.	At Year 6
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years	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.	At Year 7
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years	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.	At Year 8
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years	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.	At Year 9
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years	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.	At Year 10
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years	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.	At Year 6
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years	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.	At Year 7
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years	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.	At Year 8
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years	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.	At Year 9
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years	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.	At Year 10

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: Novartis Vaccines

Publications and helpful links

General Publications

• Beran J, Lattanzi M, Xie F, Moraschini L, Galgani I. Second five-year follow-up after a booster vaccination against tick-borne encephalitis following different primary vaccination schedules demonstrates at least 10 years antibody persistence. Vaccine. 2019 Jul 26;37(32):4623-4629. doi: 10.1016/j.vaccine.2017.12.081. Epub 2018 Feb 1.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2012
• Primary Completion (Actual): September 30, 2016
• Study Completion (Actual): September 30, 2016

Study Registration Dates

• First Submitted: March 13, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 23, 2012

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Long term immunogenicity study
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Tick-Borne Diseases; Encephalitis; Virus Diseases; Encephalitis, Tick-Borne
• Other Study ID Numbers: 205335; 2011-003255-19 (EudraCT Number); V48P7E2 (Other Identifier: Novartis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No