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

August 11, 2021 updated by: GlaxoSmithKline

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Time Frame: At Year 7
Antibody titers were measured by GSK NT assay.
At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Time Frame: At Year 8
Antibody titers were measured by GSK NT assay.
At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Time Frame: At Year 9
Antibody titers were measured by GSK NT assay.
At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2
Time Frame: At Year 10
Antibody titers were measured by GSK NT assay.
At Year 10
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Time Frame: At Year 6
Antibody titers were measured by GSK NT assay.
At Year 6
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Time Frame: At Year 7
Antibody titers were measured by GSK NT assay.
At Year 7
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Time Frame: At Year 8
Antibody titers were measured by GSK NT assay.
At Year 8
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Time Frame: At Year 9
Antibody titers were measured by GSK NT assay.
At Year 9
Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10
Time Frame: At Year 10
Antibody titers were measured by GSK NT assay.
At Year 10
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.
At Year 6
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.
At Year 7
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.
At year 8
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.
At Year 9
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.
At Year 10
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).
At Year 6
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).
At Year 7
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).
At Year 8
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).
At Year 9
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).
At Year 10
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.
At Year 6
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.
At Year 7
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.
At Year 8
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.
At Year 9
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.
At Year 10
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.
At Year 6
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.
At Year 7
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.
At Year 8
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.
At Year 9
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.
At Year 10
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.
At Year 6
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.
At Year 7
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.
At Year 8
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.
At Year 9
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.
At Year 10
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.
At Year 6
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.
At Year 7
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.
At Year 8
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.
At Year 9
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.
At Year 10
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.
At Year 6
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.
At Year 7
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.
At Year 8
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.
At Year 9
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.
At Year 10
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.
At Year 6
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.
At Year 7
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.
At Year 8
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.
At Year 9
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.
At Year 10
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).
At Year 6
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).
At Year 7
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).
At Year 8
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).
At Year 9
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).
At Year 10
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).
At Year 6
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).
At Year 7
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).
At Year 8
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).
At Year 9
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).
At Year 10
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).
At Year 6
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).
At Year 7
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).
At Year 8
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).
At Year 9
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).
At Year 10
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.
At Year 6
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.
At Year 7
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.
At Year 8
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.
At Year 9
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.
At Year 10
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.
At Year 6
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.
At Year 7
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.
At Year 8
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.
At Year 9
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.
At Year 10
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.
At Year 6
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.
At Year 7
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.
At Year 8
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.
At Year 9
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.
At Year 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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