xml: <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/NCT06006858</url>
    </required_header>
    <id_info>
      <org_study_id>COV19M-0422</org_study_id>
      <nct_id>NCT06006858</nct_id>
    </id_info>
    <brief_title>Post Authorization Safety Study Moderna COVID-19 Primary Vaccine</brief_title>
    <official_title>Safety Profile Following Moderna COVID-19 Primary Vaccine in Healthy Adults Aged ≥ 18 Years in Indonesia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>PT Bio Farma</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Advisory Immunization Committee Indonesia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>PT Bio Farma</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary&#xD;
        Vaccine&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and&#xD;
        systemic reaction after immunization with Moderna COVID-19 vaccine using retrospective cohort&#xD;
        study trial design to assess safety profile following Moderna COVID-19 primary vaccine in&#xD;
        healthy adults aged ≥ 18 years in Indonesia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 3, 2022</start_date>
    <completion_date type="Actual">March 31, 2023</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Local Reactions Following Moderna COVID-19 Vaccine</measure>
      <time_frame>28 Days after each dose</time_frame>
      <description>Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Reactions Following Moderna COVID-19 Vaccine</measure>
      <time_frame>28 Days after each dose</time_frame>
      <description>Percentage of subject with systemic reactions following immunization with Moderna COVID-19</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Immediate Reactions</measure>
      <time_frame>30 minutes after each dose</time_frame>
      <description>percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-3 Days Reactions</measure>
      <time_frame>1-3 minutes after each dose</time_frame>
      <description>percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>4-7 Days Reactions</measure>
      <time_frame>4-7 Days after each dose</time_frame>
      <description>percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>8-28 Days Reactions</measure>
      <time_frame>8-28 Days after each dose</time_frame>
      <description>percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious Reactions</measure>
      <time_frame>28 Days after each dose</time_frame>
      <description>Any serious adverse events following immunization with Moderna COVID-19 vaccine</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">1284</enrollment>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>Moderna COVID-19 Vaccine</arm_group_label>
      <description>Clinically healthy adults aged ≥ 18 years who received Primary Moderna COVID-19 Vaccine</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Moderna COVID-19 Vaccine</intervention_name>
      <description>Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.</description>
      <arm_group_label>Moderna COVID-19 Vaccine</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy adults aged ≥ 18 years&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Clinically healthy adults aged ≥ 18 years.&#xD;
  &#xD;
            2. Subjects have been informed properly regarding the study and accepted to be enrolled&#xD;
               in this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of&#xD;
          receiving the Moderna COVID-19 vaccine.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Julitasari Sundoro, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Advisory Immunization Committee</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Gambir Public Health Center</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>Jakarta</state>
          <zip>10130</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Johar Baru Public Health Center</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>Jakarta</state>
          <zip>10560</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Cempaka Putih Public Health Center</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>Jakarta</state>
          <zip>10570</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Kemayoran Public Health Center</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>Jakarta</state>
          <zip>10640</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Palmerah Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>11480</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Kebon Jeruk Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>11530</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Cengkareng Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>11730</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Kebayoran Lama Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>12240</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Tebet Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>12820</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Setiabudi Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>12980</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Pulo Gadung Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>13260</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Duren Sawit Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>13420</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Regional Hospital Duren Sawit</name>
        <address>
          <city>Jakarta</city>
          <zip>13440</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Kramat Jati Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>13510</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Cilincing Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>14120</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Koja Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>14260</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Tanjung Priok Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>14310</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Pademangan Public Health Center</name>
        <address>
          <city>Jakarta</city>
          <zip>14410</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>COVID-19</keyword>
    <keyword>Moderna Vaccine</keyword>
    <keyword>Safety Vaccine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006858
  org study id: COV19M-0422
  nct id: NCT06006858
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary
        Vaccine
  This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and
        systemic reaction after immunization with Moderna COVID-19 vaccine using retrospective cohort
        study trial design to assess safety profile following Moderna COVID-19 primary vaccine in
        healthy adults aged ≥ 18 years in Indonesia.
  observational model: Other
  time perspective: Retrospective
  measure: Local Reactions Following Moderna COVID-19 Vaccine
  time frame: 28 Days after each dose
  description: Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine.
  measure: Systemic Reactions Following Moderna COVID-19 Vaccine
  time frame: 28 Days after each dose
  description: Percentage of subject with systemic reactions following immunization with Moderna COVID-19
  measure: Immediate Reactions
  time frame: 30 minutes after each dose
  description: percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
  measure: 1-3 Days Reactions
  time frame: 1-3 minutes after each dose
  description: percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
  measure: 4-7 Days Reactions
  time frame: 4-7 Days after each dose
  description: percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
  measure: 8-28 Days Reactions
  time frame: 8-28 Days after each dose
  description: percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
  measure: Serious Reactions
  time frame: 28 Days after each dose
  description: Any serious adverse events following immunization with Moderna COVID-19 vaccine
  arm group label: Moderna COVID-19 Vaccine
  description: Clinically healthy adults aged ≥ 18 years who received Primary Moderna COVID-19 Vaccine
  intervention type: Biological
  intervention name: Moderna COVID-19 Vaccine
  description: Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.
  arm group label: Moderna COVID-19 Vaccine
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Julitasari Sundoro, MD
  role: Principal Investigator
  affiliation: National Advisory Immunization Committee
  facility: 
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  country: Indonesia
  responsible party type: Sponsor
  mesh term: COVID-19
  sharing ipd: No