<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/NCT02991872</url>
  </required_header>
  <id_info>
    <org_study_id>205634</org_study_id>
    <secondary_id>V49_24E1</secondary_id>
    <nct_id>NCT02991872</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Persistence of Immune Responses After Post-exposure Prophylaxis of Rabipur® (Purified Chicken-embryo Cell Rabies Vaccine) in Chinese Children</brief_title>
  <official_title>A Phase IV, Open Label, Single-center Extension Study, to Evaluate the Long-term Persistence of Immune Responses After Post-exposure Prophylaxis With Purified Chicken-embryo Cell Rabies Vaccine in Chinese Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the long-term persistence of immune responses&#xD;
      approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in&#xD;
      2012 according to Essen (1-1-1-1-1) or Zagreb (2-1-1) intramuscular (IM) regimens in the&#xD;
      subset of subjects who participated in the parent study (V49_24 [NCT01680016]) who were aged&#xD;
      ≥6 and ≤17 years at the time of enrollment.&#xD;
&#xD;
      This study is aimed to respond to a post-marketing commitment by the China Food and Drug&#xD;
      Administration (CFDA) requested at the time of the renewal of the purified chicken-embryo&#xD;
      cell rabies vaccine license in China, granted in August 2015.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 16, 2016</start_date>
  <completion_date type="Actual">March 12, 2017</completion_date>
  <primary_completion_date type="Actual">March 12, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rabies Virus Neutralizing Antibody(RVNA) GMCs as measured by rapid fluorescent focus inhibition test(RFFIT) measured in the study, following the Post-Exposure Prophylaxis(PEP) received in the V49_24 (NCT01680016) parent study (Zagreb and Essen regimens).</measure>
    <time_frame>Day-1/Visit-1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with RVNA concentration ≥ 0.5 IU/mL measured in this study, following the PEP received in the V49_24 (NCT01680016) parent study (Zagreb and Essen regimens).</measure>
    <time_frame>Day-1/Visit-1</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Virus Diseases</condition>
  <arm_group>
    <arm_group_label>V49_24E1 Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Up to 225 subjects, who completed the full PEP rabies regimens in the parent study V49_24 (NCT01680016), will be invited to participate to this extension study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>Subjects aged from ≥6 to ≤17 years at the time of enrolment in the parent clinical trial (following the CFDA post-marketing commitment requirement) and who received the full PEP rabies regimen as an intramuscular injection according to the vaccine group to which they were assigned in the V49_24 (NCT01680016) study will be invited to take part in this study. Single blood draw from subjects at Day-1/Visit-1. Subjects will be observed for 15 minutes after the blood draw.</description>
    <arm_group_label>V49_24E1 Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects with age ≥ 6 and ≤17 at the time of enrollment in the parent study who signed&#xD;
             the informed consent prior to the extension study entry, who received the full PEP in&#xD;
             the parent study according to either the Zagreb or Essen intramuscular regimens.&#xD;
&#xD;
          2. Subjects who or whose parent(s)/legal guardian(s) have voluntarily given written&#xD;
             informed consent/assent for this extension study after the nature of the study has&#xD;
             been explained according to local regulatory requirements, prior to study entry.&#xD;
&#xD;
          3. Individuals who can comply with study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Prior to extension study entry, each subject must not have:&#xD;
&#xD;
          1. Documented medical history of exposure to rabies or rabies prophylaxis after&#xD;
             completion of the parent study (V49_24 [NCT01680016]) and before study start.&#xD;
&#xD;
          2. Participated in the parent study (V49_24 [NCT01680016]) but not received the full PEP&#xD;
             vaccination course (or received it out of window) following assignment to either&#xD;
             Zagreb or Essen regimen during the parent study.&#xD;
&#xD;
          3. Progressive, unstable or uncontrolled clinical conditions.&#xD;
&#xD;
          4. Clinical conditions representing a contraindication to blood draws.&#xD;
&#xD;
          5. Abnormal function of the immune system resulting from:&#xD;
&#xD;
               1. Clinical conditions.&#xD;
&#xD;
               2. Systemic administration of corticosteroids for more than 14 consecutive days&#xD;
                  within 90 days prior to informed consent for all age groups.&#xD;
&#xD;
               3. Administration of antineoplastic and immunomodulating agents or radiotherapy&#xD;
                  within 90 days prior to informed consent for all age groups.&#xD;
&#xD;
          6. Received immunoglobulins or any blood products within 180 days prior to informed&#xD;
             consent for all age groups.&#xD;
&#xD;
          7. Study personnel as an immediate family or household member.&#xD;
&#xD;
          8. Any other clinical condition that, in the opinion of the investigator, might pose&#xD;
             additional risk to the subject due to participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>22 Years</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>Mengshan</city>
        <zip>546700</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>April 10, 2017</last_update_submitted>
  <last_update_submitted_qc>April 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Persistence</keyword>
  <keyword>Purified chicken-embryo cell rabies vaccine</keyword>
  <keyword>Rabies Virus Neutralizing Antibody (RVNA)</keyword>
  <keyword>Immunogenicity</keyword>
  <keyword>Post-Exposure Prophylaxis (PEP)</keyword>
  <keyword>Rabipur</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Rabies</mesh_term>
  </condition_browse>
  <!-- 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/NCT02991872
org study id: 205634
secondary id: V49_24E1
nct id: NCT02991872
lead sponsor: 
The purpose of this study is to evaluate the long-term persistence of immune responses
      approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in
      2012 according to Essen (1-1-1-1-1) or Zagreb (2-1-1) intramuscular (IM) regimens in the
      subset of subjects who participated in the parent study (V49_24 [NCT01680016]) who were aged
      ≥6 and ≤17 years at the time of enrollment.

      This study is aimed to respond to a post-marketing commitment by the China Food and Drug
      Administration (CFDA) requested at the time of the renewal of the purified chicken-embryo
      cell rabies vaccine license in China, granted in August 2015.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Rabies Virus Neutralizing Antibody(RVNA) GMCs as measured by rapid fluorescent focus inhibition test(RFFIT) measured in the study, following the Post-Exposure Prophylaxis(PEP) received in the V49_24 (NCT01680016) parent study (Zagreb and Essen regimens).
time frame: Day-1/Visit-1
measure: Percentage of subjects with RVNA concentration ≥ 0.5 IU/mL measured in this study, following the PEP received in the V49_24 (NCT01680016) parent study (Zagreb and Essen regimens).
time frame: Day-1/Visit-1
arm group label: V49_24E1 Group
arm group type: Other
description: Up to 225 subjects, who completed the full PEP rabies regimens in the parent study V49_24 (NCT01680016), will be invited to participate to this extension study.
intervention type: Procedure
intervention name: Blood draw
description: Subjects aged from ≥6 to ≤17 years at the time of enrolment in the parent clinical trial (following the CFDA post-marketing commitment requirement) and who received the full PEP rabies regimen as an intramuscular injection according to the vaccine group to which they were assigned in the V49_24 (NCT01680016) study will be invited to take part in this study. Single blood draw from subjects at Day-1/Visit-1. Subjects will be observed for 15 minutes after the blood draw.
arm group label: V49_24E1 Group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 22 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: China
responsible party type: Sponsor
mesh term: Virus Diseases
mesh term: Rabies