<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03294135</url>
  </required_header>
  <id_info>
    <org_study_id>205847</org_study_id>
    <secondary_id>2017-001356-59</secondary_id>
    <nct_id>NCT03294135</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to continue the evaluation of antibody persistence through 11 to&#xD;
      15 years after first booster with Tick-Borne Encephalitis (TBE) vaccine. This study will&#xD;
      further investigate the booster response in subjects who will receive their second booster&#xD;
      dose* in this study.&#xD;
&#xD;
      * Any booster given in this study will be the second that the subject has received (with&#xD;
      regard to the follow-up of the previous study).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2017</start_date>
  <completion_date type="Actual">March 8, 2022</completion_date>
  <primary_completion_date type="Actual">March 8, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>All subjects will come to the yearly scheduled blood draw visit for investigation of 11 to 15 year persistence of Neutralization Test (NT) titres. Subjects who have an NT titre below 10 at one of the scheduled visits will receive a second booster dose 6 months after this visit at an unscheduled visit. Subsequent data of these subjects will be analysed separately in a subgroup.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT.</measure>
    <time_frame>At Year 11</time_frame>
    <description>This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT.</measure>
    <time_frame>At Year 12</time_frame>
    <description>This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT.</measure>
    <time_frame>At Year 13</time_frame>
    <description>This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT.</measure>
    <time_frame>At Year 14</time_frame>
    <description>This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT.</measure>
    <time_frame>At Year 15</time_frame>
    <description>This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Antibody Titres as measured by GSK Biologicals' NT calculated for each of the different schedule groups.</measure>
    <time_frame>At Year 11</time_frame>
    <description>This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Antibody Titres as measured by GSK Biologicals' NT calculated for each of the different schedule groups.</measure>
    <time_frame>At Year 12</time_frame>
    <description>This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Antibody Titres as measured by GSK Biologicals' NT calculated for each of the different schedule groups.</measure>
    <time_frame>At Year 13</time_frame>
    <description>This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Antibody Titres as measured by GSK Biologicals' NT calculated for each of the different schedule groups.</measure>
    <time_frame>At Year 14</time_frame>
    <description>This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Antibody Titres as measured by GSK Biologicals' NT calculated for each of the different schedule groups.</measure>
    <time_frame>At Year 15</time_frame>
    <description>This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT, overall and by study group.</measure>
    <time_frame>At 21 days after the booster vaccination</time_frame>
    <description>This endpoint will be summarized according to the primary immunization schedule received in the parent study (V48P7).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Antibody Titres and Geometric Mean Ratios (GMRs) blood draw after/before booster as measured by GSK Biologicals' NT, overall and by study group.</measure>
    <time_frame>At 21 days after the booster vaccination</time_frame>
    <description>This endpoint will be summarized according to the primary immunization schedule received in the parent study (V48P7).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thorough description of NT waning in order to complement the analysis of persistence.</measure>
    <time_frame>At 21 days after the booster vaccination</time_frame>
    <description>This endpoint will be summarized according to the primary immunization schedule received in the parent study (V48P7).&#xD;
To complement the analysis of persistence, a thorough description of NT waning from year 1 after the first booster dose up to 15 years will be presented for the set of subjects completing the entire 15-year follow-up with no protocol deviations, including those receiving a second booster dose; for whom, a constant value of NT = 1 from the post booster visit will be used in the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of serious adverse events (SAEs).</measure>
    <time_frame>At 1 month after vaccination. Based on the timing of the booster dose, at years 11.5 (Visit 23.1), 12.5 (Visit 24.1), 13.5 (Visit 25.1), or 14.5 (Visit 26.1) or from year 15.5 (Visit 27.1) until 21 days after year 15.5 (Visit 27.2)</time_frame>
    <description>The safety endpoint for subjects who will need a second booster vaccination will be based on SAEs collection after the second booster dose.&#xD;
SAEs are defined as any untoward medical occurrence that results in death, is life- threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">194</enrollment>
  <condition>Virus Diseases</condition>
  <arm_group>
    <arm_group_label>Conventional Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a second booster vaccination six months after the blood draw only in case they result to be with an NT titre below 10 and who belonged to the following vaccination schedule in the primary studies: Primary vaccination of 66 subjects in study V48P7 on Days 0, 28 (+10) and 300 (+21), booster vaccination of 55 subjects in study V48P7E1 (NCT00387634), no vaccination in study TBEV POLYGELINE FREE (V48)-023 EXT 021 (V48P7E2) (NCT01562444).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Accelerated/Rapid Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a second booster vaccination six months after the blood draw only in case they result to be with an NT titre below 10 and who belonged to the following vaccination schedule in the primary studies: Primary vaccination of 66 subjects in study V48P7 on Days 0, 7 (+3) and 21 (+7), booster vaccination of 9 subjects in study V48P7E1 (NCT00387634) 40 subjects received their booster vaccination before enrolment in study V48P7E1 (NCT00387634), no vaccination in study TBEV POLYGELINE FREE (V48)-023 EXT 021 (V48P7E2) (NCT01562444).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Accelerated Conventional Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a second booster vaccination six months after the blood draw only in case they result to be with an NT titre below 10 and who belonged to the following vaccination schedule in the primary studies: Primary vaccination of 133 subjects in study V48P7 on Days 0, 14 (+3) and 300 (+21), booster vaccination of 109 subjects in study V48P7E1 (NCT00387634), no vaccination in study TBEV POLYGELINE FREE (V48)-023 EXT 021 (V48P7E2) (NCT01562444).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Encepur Adults</intervention_name>
    <description>One dose of the vaccine can be administered at any one unscheduled visit depending on the detection of NT below 10. It will be administered intramuscularly into the non-dominant deltoid.</description>
    <arm_group_label>Accelerated Conventional Group</arm_group_label>
    <arm_group_label>Accelerated/Rapid Group</arm_group_label>
    <arm_group_label>Conventional Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria for all subjects:&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, can and will comply with the&#xD;
             requirements of the protocol.&#xD;
&#xD;
          -  Written informed consent obtained from the subject prior to performance of any study&#xD;
             specific procedure.&#xD;
&#xD;
          -  Subjects who have participated in study V48P7E2 (NCT01562444) and who received in the&#xD;
             parent V48P7 study one of the following schedules: rapid, conventional, or accelerated&#xD;
             conventional and a booster vaccination in study V48P7E1 (NCT00387634) or before study&#xD;
             V48P7E1 (NCT00387634) (only rapid schedule).&#xD;
&#xD;
        Additional inclusion criteria for subjects who will need a second booster dose:&#xD;
&#xD;
          -  Healthy subjects as established by medical history and clinical examination before&#xD;
             entering into the study.&#xD;
&#xD;
          -  Female subjects of non-childbearing potential may be enrolled in the study.&#xD;
             Non-childbearing potential is defined as pre-menarche, current bilateral tubal&#xD;
             ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.&#xD;
&#xD;
          -  Female subjects of childbearing potential can receive the booster vaccine in the&#xD;
             study, if the subject: has practiced adequate contraception for 30 days prior to&#xD;
             vaccination, and has a negative pregnancy test on the day of vaccination, and has&#xD;
             agreed to continue adequate contraception for 2 months after booster administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Each subject must not be:&#xD;
&#xD;
          -  Unwilling or unable to give written informed consent to participate in the study.&#xD;
&#xD;
          -  Perceived to be unreliable or unavailable to complete the study.&#xD;
&#xD;
        Each subject must not have:&#xD;
&#xD;
          -  Clinical conditions representing a contraindication to blood draws.&#xD;
&#xD;
          -  Any other clinical condition that, in the opinion of the investigator, might interfere&#xD;
             with the results of the study or pose additional risk to the subject due to&#xD;
             participation in the study.&#xD;
&#xD;
          -  Received an investigational or non-registered medicinal product within 30 days prior&#xD;
             to informed consent.&#xD;
&#xD;
          -  Concurrently participating in another clinical study, at any time during the study&#xD;
             period, in which the subject has been or will be exposed to an investigational or a&#xD;
             non-investigational vaccine/product.&#xD;
&#xD;
          -  Levels of NT&lt;10 in V48P7E2 (NCT01562444) study.&#xD;
&#xD;
          -  Previous vaccination against TBE or other Flavivirus diseases with other TBE and&#xD;
             Flavivirus vaccines (e.g. Yellow fever vaccine, Dengue fever vaccine, Japanese&#xD;
             encephalitis vaccine) before, during and after completion of the V48P7E2 (NCT01562444)&#xD;
             and before starting TBEV POLYGELINE FREE-025 EXT 21 study.&#xD;
&#xD;
          -  Primary immunization with TBE vaccine in the parent study V48P7 according to the&#xD;
             modified conventional (MC) schedule.&#xD;
&#xD;
          -  History of confirmed TBE infection.&#xD;
&#xD;
          -  Known exposure to other Flaviviruses.&#xD;
&#xD;
        Each subject who will receive the second booster vaccination in this study additionally to&#xD;
        the exclusion criteria above must not have:&#xD;
&#xD;
          -  Hypersensitivity, including allergy, to any component of vaccines, medicinal products&#xD;
             or medical equipment whose use is foreseen in this study.&#xD;
&#xD;
          -  Clinical conditions representing a contraindication to intramuscular vaccination.&#xD;
&#xD;
          -  Progressive, unstable or uncontrolled clinical conditions.&#xD;
&#xD;
          -  Abnormal function of the immune system resulting from: Clinical conditions. Systemic&#xD;
             administration of corticosteroids for more than 14 consecutive days within 90 days&#xD;
             prior to informed consent. This will mean prednisone ≥20 mg/day (for adult subjects)&#xD;
             or equivalent. Inhaled and topical steroids are allowed. Administration of&#xD;
             antineoplastic and immuno-modulating agents or radiotherapy within 90 days prior to&#xD;
             vaccination.&#xD;
&#xD;
          -  Received immunoglobulins or any blood products within 180 days prior to vaccination.&#xD;
&#xD;
          -  Administration of long-acting immune-modifying drugs at any time during the study&#xD;
             period.&#xD;
&#xD;
          -  Acute disease and/or fever at the day of booster vaccination.&#xD;
&#xD;
          -  Expected general decrease in immune response.&#xD;
&#xD;
          -  Organic brain disturbances, including seizure disorders.&#xD;
&#xD;
          -  Progressive neurological disorders.&#xD;
&#xD;
          -  Suffered febrile or afebrile convulsions.&#xD;
&#xD;
          -  Serious chronic illness.&#xD;
&#xD;
          -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
             of the vaccine or chemically related substances.&#xD;
&#xD;
          -  Individuals who received any other vaccines within 14 days (for inactivated vaccines)&#xD;
             or 28 days (for live vaccines) prior to vaccination in this study or who are planning&#xD;
             to receive any vaccine within 28 days from the study vaccines.&#xD;
&#xD;
          -  Pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>50002</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>July 4, 2022</last_update_submitted>
  <last_update_submitted_qc>July 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Encepur</keyword>
  <keyword>Adults</keyword>
  <keyword>Long term immunogenicity</keyword>
  <keyword>Tick-borne Encephalitis vaccine</keyword>
  <keyword>Booster</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Virus Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>October 21, 2022</submitted>
    <returned>September 1, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03294135
org study id: 205847
secondary id: 2017-001356-59
nct id: NCT03294135
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: All subjects will come to the yearly scheduled blood draw visit for investigation of 11 to 15 year persistence of Neutralization Test (NT) titres. Subjects who have an NT titre below 10 at one of the scheduled visits will receive a second booster dose 6 months after this visit at an unscheduled visit. Subsequent data of these subjects will be analysed separately in a subgroup.
primary purpose: Prevention
masking: None (Open Label)
measure: Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT.
time frame: At Year 11
description: This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.
measure: Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT.
time frame: At Year 12
description: This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.
measure: Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT.
time frame: At Year 13
description: This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.
measure: Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT.
time frame: At Year 14
description: This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.
measure: Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT.
time frame: At Year 15
description: This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.
measure: Geometric Mean Antibody Titres as measured by GSK Biologicals' NT calculated for each of the different schedule groups.
time frame: At Year 11
description: This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.
measure: Geometric Mean Antibody Titres as measured by GSK Biologicals' NT calculated for each of the different schedule groups.
time frame: At Year 12
description: This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.
measure: Geometric Mean Antibody Titres as measured by GSK Biologicals' NT calculated for each of the different schedule groups.
time frame: At Year 13
description: This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.
measure: Geometric Mean Antibody Titres as measured by GSK Biologicals' NT calculated for each of the different schedule groups.
time frame: At Year 14
description: This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.
measure: Geometric Mean Antibody Titres as measured by GSK Biologicals' NT calculated for each of the different schedule groups.
time frame: At Year 15
description: This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, ≥ 50 years and ≥ 60 years.
measure: Percentages of subjects with detectable TBE Neutralizing Antibody Titres ≥ 2 and ≥ 10 as measured by GSK Biologicals' NT, overall and by study group.
time frame: At 21 days after the booster vaccination
description: This endpoint will be summarized according to the primary immunization schedule received in the parent study (V48P7).
measure: Geometric Mean Antibody Titres and Geometric Mean Ratios (GMRs) blood draw after/before booster as measured by GSK Biologicals' NT, overall and by study group.
time frame: At 21 days after the booster vaccination
description: This endpoint will be summarized according to the primary immunization schedule received in the parent study (V48P7).
measure: Thorough description of NT waning in order to complement the analysis of persistence.
time frame: At 21 days after the booster vaccination
description: This endpoint will be summarized according to the primary immunization schedule received in the parent study (V48P7).
To complement the analysis of persistence, a thorough description of NT waning from year 1 after the first booster dose up to 15 years will be presented for the set of subjects completing the entire 15-year follow-up with no protocol deviations, including those receiving a second booster dose; for whom, a constant value of NT = 1 from the post booster visit will be used in the analysis.
measure: Incidence of serious adverse events (SAEs).
time frame: At 1 month after vaccination. Based on the timing of the booster dose, at years 11.5 (Visit 23.1), 12.5 (Visit 24.1), 13.5 (Visit 25.1), or 14.5 (Visit 26.1) or from year 15.5 (Visit 27.1) until 21 days after year 15.5 (Visit 27.2)
description: The safety endpoint for subjects who will need a second booster vaccination will be based on SAEs collection after the second booster dose.
SAEs are defined as any untoward medical occurrence that results in death, is life- threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
arm group label: Conventional Group
arm group type: Experimental
description: Subjects will receive a second booster vaccination six months after the blood draw only in case they result to be with an NT titre below 10 and who belonged to the following vaccination schedule in the primary studies: Primary vaccination of 66 subjects in study V48P7 on Days 0, 28 (+10) and 300 (+21), booster vaccination of 55 subjects in study V48P7E1 (NCT00387634), no vaccination in study TBEV POLYGELINE FREE (V48)-023 EXT 021 (V48P7E2) (NCT01562444).
arm group label: Accelerated/Rapid Group
arm group type: Experimental
description: Subjects will receive a second booster vaccination six months after the blood draw only in case they result to be with an NT titre below 10 and who belonged to the following vaccination schedule in the primary studies: Primary vaccination of 66 subjects in study V48P7 on Days 0, 7 (+3) and 21 (+7), booster vaccination of 9 subjects in study V48P7E1 (NCT00387634) 40 subjects received their booster vaccination before enrolment in study V48P7E1 (NCT00387634), no vaccination in study TBEV POLYGELINE FREE (V48)-023 EXT 021 (V48P7E2) (NCT01562444).
arm group label: Accelerated Conventional Group
arm group type: Experimental
description: Subjects will receive a second booster vaccination six months after the blood draw only in case they result to be with an NT titre below 10 and who belonged to the following vaccination schedule in the primary studies: Primary vaccination of 133 subjects in study V48P7 on Days 0, 14 (+3) and 300 (+21), booster vaccination of 109 subjects in study V48P7E1 (NCT00387634), no vaccination in study TBEV POLYGELINE FREE (V48)-023 EXT 021 (V48P7E2) (NCT01562444).
intervention type: Biological
intervention name: Encepur Adults
description: One dose of the vaccine can be administered at any one unscheduled visit depending on the detection of NT below 10. It will be administered intramuscularly into the non-dominant deltoid.
arm group label: Accelerated Conventional Group
arm group label: Accelerated/Rapid Group
arm group label: Conventional Group
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: Czechia
responsible party type: Sponsor
mesh term: Virus Diseases
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com
submitted: October 21, 2022
returned: September 1, 2023