<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/NCT01734239</url>
  </required_header>
  <id_info>
    <org_study_id>V110-018</org_study_id>
    <nct_id>NCT01734239</nct_id>
  </id_info>
  <brief_title>A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)</brief_title>
  <official_title>A Phase III, Open-Label Clinical Trial to Study the Safety and Immunogenicity of V110 in Subjects 50 Years of Age and Older and in Subjects 2 to 49 Years of Age at Increased Risk for Pneumococcal Disease, From the Russian Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in&#xD;
      participants from the Russian population who are 50 years of age and older or 2 to 49 years&#xD;
      of age and at increased risk for pneumococcal disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2013</start_date>
  <completion_date type="Actual">October 22, 2013</completion_date>
  <primary_completion_date type="Actual">October 22, 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine</measure>
    <time_frame>Prevaccination and Day 28 after vaccination</time_frame>
    <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With &gt;=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine</measure>
    <time_frame>Day 28 postvaccination</time_frame>
    <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A &gt;=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Elevated Body Temperature (&gt;=37.6 °C Axillary / &gt;=38.0 °C Oral or Equivalent)</measure>
    <time_frame>Up to 5 days postvaccination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by &gt;=4 Participants</measure>
    <time_frame>Up to Day 14 postvaccination</time_frame>
    <description>An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in &gt;=4 participants were reported for this endpoint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting Serious Adverse Experiences</measure>
    <time_frame>Up to Day 28 postvaccination</time_frame>
    <description>A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Pneumococcal Disease</condition>
  <arm_group>
    <arm_group_label>Pneumovax™ 23: Participants Between 2 and 49 Years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pneumovax™ 23: Participants &gt;=50 Years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pneumovax™ 23</intervention_name>
    <description>Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F</description>
    <arm_group_label>Pneumovax™ 23: Participants &gt;=50 Years</arm_group_label>
    <arm_group_label>Pneumovax™ 23: Participants Between 2 and 49 Years</arm_group_label>
    <other_name>V110</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For participants 50 years of age or older: any underlying chronic illness must be in&#xD;
             stable condition&#xD;
&#xD;
          -  For participants 2 to 49 years of age: participant has an increased risk for&#xD;
             pneumococcal disease as a result of one of the following: chronic cardiovascular&#xD;
             disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver&#xD;
             disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell&#xD;
             anemia, living in a special environment or social setting such as crowded, closed&#xD;
             communities&#xD;
&#xD;
          -  Male, or female not of reproductive potential, or female of reproductive potential who&#xD;
             agrees to remain abstinent or to use 2 acceptable methods of contraception through 6&#xD;
             weeks after study vaccination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received prior vaccination with pneumococcal vaccine&#xD;
&#xD;
          -  Has known or suspected immune dysfunction or conditions associated with&#xD;
             immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term&#xD;
             systemic corticosteroids&#xD;
&#xD;
          -  Has history of autoimmune disease&#xD;
&#xD;
          -  Received a licensed live virus vaccine within 3 months before or is scheduled within 3&#xD;
             months after study vaccination&#xD;
&#xD;
          -  Received a licensed inactivated vaccine within 28 days before or is scheduled within&#xD;
             28 days after study vaccination&#xD;
&#xD;
          -  Received an investigational drug or other investigational vaccine within 2 months&#xD;
             before or is scheduled within 28 days after study vaccination (3 months if a live&#xD;
             virus vaccine)&#xD;
&#xD;
          -  Received any blood product or immunoglobulin preparation within 6 months before or 28&#xD;
             days after study vaccination&#xD;
&#xD;
          -  Hospitalized for acute illness within 3 months before study vaccination&#xD;
&#xD;
          -  Is a pregnant woman or nursing mother&#xD;
&#xD;
          -  History of invasive pneumococcal disease or of other culture-positive pneumococcal&#xD;
             disease&#xD;
&#xD;
          -  History of fever illness within 3 days before study vaccination&#xD;
&#xD;
          -  Received antibiotic therapy for any acute illness within 7 days before study&#xD;
             vaccination&#xD;
&#xD;
          -  Hypersensitivity to any components of the vaccine, including phenol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Russian Federation</country>
  </removed_countries>
  <results_reference>
    <citation>Ciprero K, Zykov KA, Briko NI, Shekar T, Sterling TM, Bitieva E, Stek JE, Musey L. Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects. Hum Vaccin Immunother. 2016 Aug 2;12(8):2142-2147. doi: 10.1080/21645515.2016.1165373. Epub 2016 May 5.</citation>
    <PMID>27149114</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <results_first_submitted>August 26, 2014</results_first_submitted>
  <results_first_submitted_qc>August 26, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 5, 2014</results_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2018</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>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>CSR Synopsis</doc_type>
      <doc_url>http://www.merck.com/clinical-trials/study.html?id=V110-018&amp;kw=V110-018&amp;tab=access</doc_url>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pneumovax™ 23: Participants Between 2 and 49 Years</title>
          <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
        </group>
        <group group_id="P2">
          <title>Pneumovax™ 23: Participants &gt;=50 Years</title>
          <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pneumovax™ 23: Participants Between 2 and 49 Years</title>
          <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
        </group>
        <group group_id="B2">
          <title>Pneumovax™ 23: Participants &gt;=50 Years</title>
          <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="52"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="102"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.2" spread="15.3"/>
                    <measurement group_id="B2" value="60.4" spread="7.7"/>
                    <measurement group_id="B3" value="40.4" spread="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine</title>
        <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays</description>
        <time_frame>Prevaccination and Day 28 after vaccination</time_frame>
        <population>The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range</population>
        <group_list>
          <group group_id="O1">
            <title>Pneumovax™ 23: Participants Between 2 and 49 Years</title>
            <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pneumovax™ 23: Participants &gt;=50 Years</title>
            <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine</title>
          <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays</description>
          <population>The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1 prevaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.2" upper_limit="0.3"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.2" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1 Day 28 postvaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="3.0" upper_limit="5.4"/>
                    <measurement group_id="O2" value="2.5" lower_limit="1.7" upper_limit="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6B prevaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.4" upper_limit="0.8"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0.5" upper_limit="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6B Day 28 postvaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" lower_limit="1.8" upper_limit="3.9"/>
                    <measurement group_id="O2" value="5.3" lower_limit="3.4" upper_limit="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 14 prevaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0.8" upper_limit="2.0"/>
                    <measurement group_id="O2" value="3.6" lower_limit="2.5" upper_limit="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 14 Day 28 postvaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2" lower_limit="8.7" upper_limit="20.1"/>
                    <measurement group_id="O2" value="32.7" lower_limit="22.7" upper_limit="47.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 19F prevaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1.1" upper_limit="2.2"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.1" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 19F Day 28 postvaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" lower_limit="9.0" upper_limit="17.8"/>
                    <measurement group_id="O2" value="9.9" lower_limit="7.0" upper_limit="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 23F prevaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.4" upper_limit="1.0"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.7" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 23F Day 28 postvaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" lower_limit="3.6" upper_limit="7.7"/>
                    <measurement group_id="O2" value="8.1" lower_limit="5.3" upper_limit="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With &gt;=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine</title>
        <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A &gt;=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.</description>
        <time_frame>Day 28 postvaccination</time_frame>
        <population>The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range</population>
        <group_list>
          <group group_id="O1">
            <title>Pneumovax™ 23: Participants Between 2 and 49 Years</title>
            <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pneumovax™ 23: Participants &gt;=50 Years</title>
            <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With &gt;=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine</title>
          <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A &gt;=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.</description>
          <population>The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.2" lower_limit="86.8" upper_limit="99.5"/>
                    <measurement group_id="O2" value="87.5" lower_limit="74.8" upper_limit="95.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.9" lower_limit="63.2" upper_limit="87.5"/>
                    <measurement group_id="O2" value="89.6" lower_limit="77.3" upper_limit="96.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.5" lower_limit="76.6" upper_limit="95.6"/>
                    <measurement group_id="O2" value="89.6" lower_limit="77.3" upper_limit="96.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 19F</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7" lower_limit="69.7" upper_limit="91.8"/>
                    <measurement group_id="O2" value="79.2" lower_limit="65.0" upper_limit="89.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 23F</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.8" lower_limit="67.5" upper_limit="90.4"/>
                    <measurement group_id="O2" value="87.5" lower_limit="74.8" upper_limit="95.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Elevated Body Temperature (&gt;=37.6 °C Axillary / &gt;=38.0 °C Oral or Equivalent)</title>
        <time_frame>Up to 5 days postvaccination</time_frame>
        <population>The All Subjects as Treated population included all enrolled participants</population>
        <group_list>
          <group group_id="O1">
            <title>Pneumovax™ 23: Participants Between 2 and 49 Years</title>
            <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pneumovax™ 23: Participants &gt;=50 Years</title>
            <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Elevated Body Temperature (&gt;=37.6 °C Axillary / &gt;=38.0 °C Oral or Equivalent)</title>
          <population>The All Subjects as Treated population included all enrolled participants</population>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by &gt;=4 Participants</title>
        <description>An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in &gt;=4 participants were reported for this endpoint.</description>
        <time_frame>Up to Day 14 postvaccination</time_frame>
        <population>The All Subjects as Treated population included all enrolled participants</population>
        <group_list>
          <group group_id="O1">
            <title>Pneumovax™ 23: Participants Between 2 and 49 Years</title>
            <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pneumovax™ 23: Participants &gt;=50 Years</title>
            <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by &gt;=4 Participants</title>
          <description>An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in &gt;=4 participants were reported for this endpoint.</description>
          <population>The All Subjects as Treated population included all enrolled participants</population>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Serious Adverse Experiences</title>
        <description>A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention</description>
        <time_frame>Up to Day 28 postvaccination</time_frame>
        <population>The All Subjects as Treated population included all enrolled participants</population>
        <group_list>
          <group group_id="O1">
            <title>Pneumovax™ 23: Participants Between 2 and 49 Years</title>
            <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pneumovax™ 23: Participants &gt;=50 Years</title>
            <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Serious Adverse Experiences</title>
          <description>A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention</description>
          <population>The All Subjects as Treated population included all enrolled participants</population>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse experiences were collected through Day 14 postvaccination; serious adverse experiences were collected through Day 28 postvaccination</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pneumovax™ 23</title>
          <description>Participants received a single 0.5 mL intramuscular injection on Day 1</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01734239
org study id: V110-018
nct id: NCT01734239
lead sponsor: 
has dmc: No
The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in
      participants from the Russian population who are 50 years of age and older or 2 to 49 years
      of age and at increased risk for pneumococcal disease
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine
time frame: Prevaccination and Day 28 after vaccination
description: Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays
measure: Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine
time frame: Day 28 postvaccination
description: Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.
measure: Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)
time frame: Up to 5 days postvaccination
measure: Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants
time frame: Up to Day 14 postvaccination
description: An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint.
measure: Number of Participants Reporting Serious Adverse Experiences
time frame: Up to Day 28 postvaccination
description: A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention
arm group label: Pneumovax™ 23: Participants Between 2 and 49 Years
arm group type: Experimental
description: Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1
arm group label: Pneumovax™ 23: Participants >=50 Years
arm group type: Experimental
description: Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1
intervention type: Biological
intervention name: Pneumovax™ 23
description: Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F
arm group label: Pneumovax™ 23: Participants >=50 Years
arm group label: Pneumovax™ 23: Participants Between 2 and 49 Years
other name: V110
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Russian Federation
citation: Ciprero K, Zykov KA, Briko NI, Shekar T, Sterling TM, Bitieva E, Stek JE, Musey L. Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects. Hum Vaccin Immunother. 2016 Aug 2;12(8):2142-2147. doi: 10.1080/21645515.2016.1165373. Epub 2016 May 5.
PMID: 27149114
responsible party type: Sponsor
mesh term: Pneumococcal Infections
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
study doc: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 