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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have completed prior study - V48P7E1.
排除标准
- •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.
结局指标
主要结局
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
时间窗: At Year 10
Antibody titers were measured by GSK NT assay.
Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines
时间窗: 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).
Evaluation of GMTs in the Age Group of ≥ 50 Years
时间窗: 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.
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years
时间窗: 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.
Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2
时间窗: At Year 6
Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years
时间窗: 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).
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
时间窗: At Year 10
Antibody titers were measured by GSK NT assay.
Evaluation of Geometric Mean Antibody Titers (GMTs)
时间窗: 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.
GMRs Calculated to Pre Booster Baselines
时间窗: 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).
GMRs Calculated to Post Booster Baselines
时间窗: 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.
Evaluation of GMTs in the Age Group of ≥ 60 Years
时间窗: 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.
GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years
时间窗: 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).
GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years
时间窗: 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.
Evaluation of GMTs
时间窗: 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.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups
时间窗: At Year 10
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups
时间窗: At Year 10
Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.
Evaluation of GMTs in the Age Group of 15-49 Years
时间窗: 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.
GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years
时间窗: 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).
GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years
时间窗: 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.
次要结局
未报告次要终点