<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/NCT02201030</url>
  </required_header>
  <id_info>
    <org_study_id>NBP606_PCVI_III_2013</org_study_id>
    <nct_id>NCT02201030</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety Study of NBP606 in Healthy Infants</brief_title>
  <official_title>Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Primary Vaccination With NBP606 in Healthy Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SK Chemicals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SK Chemicals Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the immunogenicity and safety of primary vaccination with NBP606&#xD;
      compared to the existing commercial vaccine, when given concomitantly with routine pediatric&#xD;
      vaccinations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2014</start_date>
  <completion_date type="Actual">October 21, 2016</completion_date>
  <primary_completion_date type="Actual">October 21, 2016</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects with the targeted antibody concentration</measure>
    <time_frame>1 month after the primary vaccination</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric mean concentration ratio</measure>
    <time_frame>1 month after the primary vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">577</enrollment>
  <condition>Pneumococcal Infections</condition>
  <arm_group>
    <arm_group_label>NBP606</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>13-valent pneumococcal conjugate vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prevnar13</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>13-valent pneumococcal conjugate vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NBP606</intervention_name>
    <description>A single intramuscular injection into the thigh</description>
    <arm_group_label>NBP606</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Prevnar13</intervention_name>
    <description>A single intramuscular injection into the thigh</description>
    <arm_group_label>Prevnar13</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of&#xD;
             enrollment.&#xD;
&#xD;
          -  The LAR (Legally Authorized Representative) who understand the requirements of the&#xD;
             study and voluntarily consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to any components of the pneumococcal vaccine&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient conditions&#xD;
&#xD;
          -  Coagulation disorder contraindicating IM(intramuscular) vaccination&#xD;
&#xD;
          -  Subject has received any licensed vaccine(not including BCG and Hepatitis B)&#xD;
&#xD;
          -  Participation to another study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>42 Days</minimum_age>
    <maximum_age>98 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Confidential Investigator</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Confidential</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>April 17, 2020</last_update_submitted>
  <last_update_submitted_qc>April 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2020</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>Pneumococcal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02201030
org study id: NBP606_PCVI_III_2013
nct id: NCT02201030
lead sponsor: 
has dmc: No
This study will assess the immunogenicity and safety of primary vaccination with NBP606
      compared to the existing commercial vaccine, when given concomitantly with routine pediatric
      vaccinations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Proportion of subjects with the targeted antibody concentration
time frame: 1 month after the primary vaccination
measure: Geometric mean concentration ratio
time frame: 1 month after the primary vaccination
arm group label: NBP606
arm group type: Experimental
description: 13-valent pneumococcal conjugate vaccine
arm group label: Prevnar13
arm group type: Active Comparator
description: 13-valent pneumococcal conjugate vaccine
intervention type: Biological
intervention name: NBP606
description: A single intramuscular injection into the thigh
arm group label: NBP606
intervention type: Biological
intervention name: Prevnar13
description: A single intramuscular injection into the thigh
arm group label: Prevnar13
criteria: 
gender: All
minimum age: 42 Days
maximum age: 98 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Confidential Investigator
role: Principal Investigator
affiliation: Clinical Research Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Pneumococcal Infections
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: Undecided