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
Study complete
Study complete
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
    Primary completion date:
    2021-25-10
    Observational study model:
    Not applicable
    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
    Study complete
    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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