Last updated: 09/27/2023 14:10:14

The aim of this study is to investigate the persistence of antibody response in adults up to 15 years after one booster dose of GlaxoSmithKline (GSK) Biologicals’ Encepur Adults vaccine

GSK study ID
205847
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Long term immunogenicity up to 15 years after the first booster immunization with GSK Biologicals’ Encepur Adults (Polygeline-free Tick-Borne Encephalitis vaccine for adults) in adults who received 1 of 3 different primary vaccination schedules
Trial description: The purpose of this study is to continue the evaluation of antibody persistence through 11 to 15 years after first booster with Tick-Borne Encephalitis (TBE) vaccine. This study will further investigate the booster response in subjects who will receive their second booster dose* in this study.
* Any booster given in this study will be the second that the subject has received (with regard to the follow-up of the previous study).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 11

Timeframe: At Year 11

Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 12

Timeframe: At Year 12

Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 13

Timeframe: At Year 13

Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 14

Timeframe: At Year 14

Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 10 at Year 15

Timeframe: At Year 15

Geometric Mean Antibody Titers (GMTs) by age categories at Year 11

Timeframe: At Year 11

Geometric Mean Antibody Titers (GMTs) by age categories at Year 12

Timeframe: At Year 12

Geometric Mean Antibody Titers (GMTs) by age categories at Year 13

Timeframe: At Year 13

Geometric Mean Antibody Titers (GMTs) by age categories at Year 14

Timeframe: At Year 14

Geometric Mean Antibody Titers (GMTs) by age categories at Year 15

Timeframe: At Year 15

Secondary outcomes:

Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to or above 2 and equal to or above 10 as measured by GSK Biologicals' NT, overall and by study group

Timeframe: At 21 days after the booster vaccination

Geometric Mean Antibody Titers (GMTs) as measured by GSK Biologicals' NT, overall and by study group

Timeframe: At 21 days after the booster vaccination

Geometric Mean Ratios (GMRs) blood draw after/before booster as measured by GSK Biologicals' NT, overall and by study group

Timeframe: At 21 days after the booster vaccination

Percentage of participants with detectable TBE Neutralizing Antibody Titers equal to and above 10 as measured by GSK Biologicals' NT, overall and by study group

Timeframe: From Year 1 up to Year 15

Number of participants with serious adverse events (SAEs)

Timeframe: From Day 0 to Day 21 after booster vaccination

Interventions:
Biological/vaccine: Encepur Adults
Enrollment:
194
Observational study model:
Not applicable
Primary completion date:
2021-25-10
Time perspective:
Not applicable
Clinical publications:
Beran J, Lattanzi M, Costantini M, Pammolli A, Galgani I. Sustained antibody persistence for at least 15 years after a booster vaccination against tick-borne encephalitis following different primary vaccination schedules: Third 5-year follow-up. Vaccine. 2023 May 2:S0264-410X(23)00485-1. DOI: 10.1016/j.vaccine.2023.04.061. PMID: 37142462.
Medical condition
Virus Diseases
Product
GSK3536859A
Collaborators
Not applicable
Study date(s)
October 2017 to October 2021
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
25+ years
Accepts healthy volunteers
Yes
  • Inclusion criteria for all subjects:
  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Each subject must not be:
  • Unwilling or unable to give written informed consent to participate in the study.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 50002
Status
Study Complete

Study documents

Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2021-25-10
Actual study completion date
2021-25-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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