<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/NCT02257645</url>
  </required_header>
  <id_info>
    <org_study_id>LG-VFOS001</org_study_id>
    <nct_id>NCT02257645</nct_id>
  </id_info>
  <brief_title>Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks</brief_title>
  <official_title>A Multicenter, Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization Against Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus Influenza Type B in Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LG Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LG Life Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active&#xD;
      primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus&#xD;
      influenza type B in infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Euforvac-Hib vaccine manufactured by LG Life science in Korea, but it's not marketed in&#xD;
      Korea. It is distributed to UN agencies in diverse countries. Thus, WHO recommended LG Life&#xD;
      Science to conduct the safety study for assessing the vaccine safety if Euforvac-Hib is&#xD;
      prequalified.&#xD;
&#xD;
      The objectives of this safety study are to identify any problems and questionable issues&#xD;
      likely to emerge from the actual use of Euforvac-Hib vaccine after launching in the market.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse event</measure>
    <time_frame>up to 12 weeks after vaccination</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Diphtheria</condition>
  <condition>Tetanus</condition>
  <condition>Pertussis</condition>
  <condition>Hepatitis B</condition>
  <condition>Haemophilus Influenza Type B</condition>
  <arm_group>
    <arm_group_label>Euforvac-Hib vaccine</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Infant from 6 weeks of age.who is given this vaccine for active primary immunization&#xD;
        against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who had been signed informed consent by subjects legally acceptable&#xD;
             Representative&#xD;
&#xD;
          2. Infant from 6 weeks of age.who is given this vaccine for active primary immunization&#xD;
             against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with hypersensitivity to any component for the vaccine&#xD;
&#xD;
          2. Patients who had a severe reaction to a previous dose of the combination vaccine or&#xD;
             any of its constituents is absolute contraindication to subsequent doses of the&#xD;
             combination vaccine.&#xD;
&#xD;
          3. Patients who had pertussis, encephalopathy or other serious neurological abnormality&#xD;
             in the newborn period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Weeks</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hyejin Yoon</last_name>
    <phone>82-2-6924-3148</phone>
    <email>hyejin0611@lgls.com</email>
  </overall_contact>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 5, 2014</last_update_submitted>
  <last_update_submitted_qc>October 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Whooping Cough</mesh_term>
    <mesh_term>Tetanus</mesh_term>
    <mesh_term>Diphtheria</mesh_term>
    <mesh_term>Hepatitis</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/NCT02257645
org study id: LG-VFOS001
nct id: NCT02257645
lead sponsor: 
has dmc: No
A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active
      primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus
      influenza type B in infants.
Euforvac-Hib vaccine manufactured by LG Life science in Korea, but it's not marketed in
      Korea. It is distributed to UN agencies in diverse countries. Thus, WHO recommended LG Life
      Science to conduct the safety study for assessing the vaccine safety if Euforvac-Hib is
      prequalified.

      The objectives of this safety study are to identify any problems and questionable issues
      likely to emerge from the actual use of Euforvac-Hib vaccine after launching in the market.
observational model: Cohort
time perspective: Prospective
measure: Adverse event
time frame: up to 12 weeks after vaccination
arm group label: Euforvac-Hib vaccine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Weeks
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hyejin Yoon
phone: 82-2-6924-3148
email: hyejin0611@lgls.com
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Hepatitis B
mesh term: Whooping Cough
mesh term: Tetanus
mesh term: Diphtheria
mesh term: Hepatitis