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

Virus Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562444
• Other study ID #: 205335
• Secondary ID: 2011-003255-19V4
• Status: Completed
• Phase: Phase 4
• Start date: March 8, 2012
• Est. completion date: September 30, 2016

Study information

• Verified date: August 2021
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne
• Tick Borne Encephalitis
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Czechia	GSK Investigational Site	Hradec Kralove

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Novartis Vaccines

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Subjects With Detectable TBE Antibody Titers = 2	Antibody titers were measured by GSK NT assay.	At Year 7
Primary	Percentage of Subjects With Detectable TBE Antibody Titers = 2	Antibody titers were measured by GSK NT assay.	At Year 8
Primary	Percentage of Subjects With Detectable TBE Antibody Titers = 2	Antibody titers were measured by GSK NT assay.	At Year 9
Primary	Percentage of Subjects With Detectable TBE Antibody Titers = 2	Antibody titers were measured by GSK NT assay.	At Year 10
Primary	Percentage of Subjects With Detectable TBE Antibody Titers = 10	Antibody titers were measured by GSK NT assay.	At Year 6
Primary	Percentage of Subjects With Detectable TBE Antibody Titers = 10	Antibody titers were measured by GSK NT assay.	At Year 7
Primary	Percentage of Subjects With Detectable TBE Antibody Titers = 10	Antibody titers were measured by GSK NT assay.	At Year 8
Primary	Percentage of Subjects With Detectable TBE Antibody Titers = 10	Antibody titers were measured by GSK NT assay.	At Year 9
Primary	Percentage of Subjects With Detectable TBE Antibody Titers = 10	Antibody titers were measured by GSK NT assay.	At Year 10
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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