<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/NCT04453241</url>
  </required_header>
  <id_info>
    <org_study_id>PR-18062</org_study_id>
    <nct_id>NCT04453241</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety Study of NBP615 in Healthy Female</brief_title>
  <official_title>A Randomized, Double-Blinded, Active Controlled, Phase I/ II Clinical Trial to Assess the Immunogenicity, Safety, and Tolerability of NBP615 Vaccine in Healthy Female Participants Aged 19 to 26 Years and Adolescent Aged 9 to 13 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SK Bioscience Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SK Bioscience Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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 was a randomized, double-blind, active-controlled, phase I/II clinical trial to enroll&#xD;
      200 healthy female including 80 healthy adult aged 19 to 26 years and 120 adolescents aged 9&#xD;
      to 13 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to confirm the safety, 80 healthy adult were enrolled first. Eligible subjects were&#xD;
      randomized into 1:1 ratio to receive three doses of either test vaccine (NPB615) or&#xD;
      comparator vaccine (Gardasil). The safety of the test vaccine (NBP615) was confirmed by 2nd&#xD;
      vaccination in adult subjects. After that, enrolment of 120 adolescent subjects proceeded.&#xD;
      Eligible subjects who previously agreed to participate in the study were screened and only&#xD;
      those subjects who met the inclusion/exclusion criteria were randomized in to 1:1 to receive&#xD;
      two doses of test vaccine (NBP615) or comparator (Gardasil pre-filled syringe). 0.5 ml&#xD;
      Intramuscular injection at were given at each vaccination and two blood sample, pre vaccine&#xD;
      and post vaccine 4 weeks after completion of vaccine were collected to assess the&#xD;
      immunogenicity of NBP615 and Gardasil, comparator vaccine. Solicited adverse events occurred&#xD;
      up to 7 days after each dose of the investigational product were collected in the diary card.&#xD;
      Unsolicited adverse events occurred up to 28 days after each dose of the investigational&#xD;
      product were collated in the diary card. Serious adverse events were collected during the&#xD;
      entire study period. In addition to this safety data was collected through the study period&#xD;
      by active contact with the study participants by doing home visit or by telephone contact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2018</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Geometric mean titer measured by Enzyme-linked Immunosorbent Assay(ELISA)</measure>
    <time_frame>4 weeks after the vaccination</time_frame>
    <description>geometric mean titer against anti-HPV 6, 11, 16, and 18 for each treatment group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>seroconversion rate measured by Enzyme-linked Immunosorbent Assay(ELISA)</measure>
    <time_frame>4 weeks after the vaccination</time_frame>
    <description>proportion of subjects who seroconverted from seronegative at baseline to seropositive at post vaccination for anti-HPV 6, 11, 16, and 18</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric mean titer measured by pseudovirion-based neutralization assay(PBNA)</measure>
    <time_frame>4 weeks after the vaccination</time_frame>
    <description>geometric mean titer against anti-HPV 6, 11, 16, and 18 for each treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rate of Solicited Adverse Event</measure>
    <time_frame>7 days after the vaccination</time_frame>
    <description>Solicited local/systemic adverse event after vaccination</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>NBP615</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult : 3 doses of vaccination Adolescent :2 doses of vaccination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GARDASIL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adult : 3 doses of vaccination Adolescent :2 doses of vaccination</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NBP615</intervention_name>
    <description>Intramuscular injection, 0.5ml</description>
    <arm_group_label>NBP615</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Gardasil</intervention_name>
    <description>Intramuscular injection, 0.5ml</description>
    <arm_group_label>GARDASIL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        [Inclusion Criteria]&#xD;
&#xD;
          -  Healthy adult(19 to 26 years)/adolescent(9 to 13 years) of age at the time of the 1st&#xD;
             vaccination&#xD;
&#xD;
          -  Participant fully understands study procedures, and voluntarily agrees to participate&#xD;
             in the study and follow the study procedure by giving written informed consent&#xD;
&#xD;
        [Exclusion Criteria]&#xD;
&#xD;
          -  Received a marketed Human papillomavirus(HPV) vaccine, or had participated in an HPV&#xD;
             vaccine clinical trial and had received either active agent or placebo.&#xD;
&#xD;
          -  History of hypersensitivity to any component of the study vaccines.&#xD;
&#xD;
          -  Currently immunocompromised or was diagnosed as having a congenital or acquired&#xD;
             immunodeficiency, Human Immunodeficiency Virus(HIV) infection, lymphoma, leukemia,&#xD;
             systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid&#xD;
             arthritis (JRA), inflammatory bowel disease, other autoimmune condition, or other&#xD;
             immune disorder which is decided to be medically significant by the investigator.&#xD;
&#xD;
          -  Received immunoglobulins and/or blood product within 3 months preceding the first dose&#xD;
             of study vaccine or planned administration during the study period.&#xD;
&#xD;
          -  Receiving or had received chemotherapy, immunosuppressive therapies, or radiation&#xD;
             therapy in the year prior to enrolment.&#xD;
&#xD;
          -  Chronic administration (&gt;14 days) of immune-suppressants or immune modulating drugs&#xD;
             within 3 months prior to the first vaccine dose or planned administration during the&#xD;
             study period. Inhaled, nasal and topical steroids are allowed.&#xD;
&#xD;
          -  Participant with severe thrombocytopenia or any coagulation disorder that would&#xD;
             contraindicate intramuscular injections.&#xD;
&#xD;
          -  Subject has active cervical disease or a significant history of cervical disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>k Zaman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Centre for Diarrhoeal Disease Research, Bangladesh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SK Bioscience</name>
      <address>
        <city>Gyeonggi-do</city>
        <state>Seongnam-si</state>
        <zip>13494</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>September 24, 2021</last_update_submitted>
  <last_update_submitted_qc>September 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</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>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04453241
org study id: PR-18062
nct id: NCT04453241
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This was a randomized, double-blind, active-controlled, phase I/II clinical trial to enroll
      200 healthy female including 80 healthy adult aged 19 to 26 years and 120 adolescents aged 9
      to 13 years.
In order to confirm the safety, 80 healthy adult were enrolled first. Eligible subjects were
      randomized into 1:1 ratio to receive three doses of either test vaccine (NPB615) or
      comparator vaccine (Gardasil). The safety of the test vaccine (NBP615) was confirmed by 2nd
      vaccination in adult subjects. After that, enrolment of 120 adolescent subjects proceeded.
      Eligible subjects who previously agreed to participate in the study were screened and only
      those subjects who met the inclusion/exclusion criteria were randomized in to 1:1 to receive
      two doses of test vaccine (NBP615) or comparator (Gardasil pre-filled syringe). 0.5 ml
      Intramuscular injection at were given at each vaccination and two blood sample, pre vaccine
      and post vaccine 4 weeks after completion of vaccine were collected to assess the
      immunogenicity of NBP615 and Gardasil, comparator vaccine. Solicited adverse events occurred
      up to 7 days after each dose of the investigational product were collected in the diary card.
      Unsolicited adverse events occurred up to 28 days after each dose of the investigational
      product were collated in the diary card. Serious adverse events were collected during the
      entire study period. In addition to this safety data was collected through the study period
      by active contact with the study participants by doing home visit or by telephone contact.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Geometric mean titer measured by Enzyme-linked Immunosorbent Assay(ELISA)
time frame: 4 weeks after the vaccination
description: geometric mean titer against anti-HPV 6, 11, 16, and 18 for each treatment group
measure: seroconversion rate measured by Enzyme-linked Immunosorbent Assay(ELISA)
time frame: 4 weeks after the vaccination
description: proportion of subjects who seroconverted from seronegative at baseline to seropositive at post vaccination for anti-HPV 6, 11, 16, and 18
measure: Geometric mean titer measured by pseudovirion-based neutralization assay(PBNA)
time frame: 4 weeks after the vaccination
description: geometric mean titer against anti-HPV 6, 11, 16, and 18 for each treatment
measure: Incidence rate of Solicited Adverse Event
time frame: 7 days after the vaccination
description: Solicited local/systemic adverse event after vaccination
arm group label: NBP615
arm group type: Experimental
description: Adult : 3 doses of vaccination Adolescent :2 doses of vaccination
arm group label: GARDASIL
arm group type: Active Comparator
description: Adult : 3 doses of vaccination Adolescent :2 doses of vaccination
intervention type: Biological
intervention name: NBP615
description: Intramuscular injection, 0.5ml
arm group label: NBP615
intervention type: Biological
intervention name: Gardasil
description: Intramuscular injection, 0.5ml
arm group label: GARDASIL
criteria: 
gender: Female
gender based: Yes
minimum age: 9 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: k Zaman, MD
role: Principal Investigator
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
sharing ipd: No