<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/NCT03840174</url>
  </required_header>
  <id_info>
    <org_study_id>V160-003</org_study_id>
    <secondary_id>V160-003</secondary_id>
    <secondary_id>194648</secondary_id>
    <nct_id>NCT03840174</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003)</brief_title>
  <official_title>A Phase I Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of V160 (Human Cytomegalovirus Vaccine) in Healthy Japanese Men</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160&#xD;
      administered by intramuscular (IM) injection in healthy Japanese male participants by&#xD;
      cytomegalovirus (CMV) serostatus. There is no formal hypothesis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Actual">November 7, 2019</completion_date>
  <primary_completion_date type="Actual">November 7, 2019</primary_completion_date>
  <phase>Phase 1</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With a Solicited Injection-site Adverse Event (AE)</measure>
    <time_frame>Up to 5 days after each vaccination</time_frame>
    <description>Participants used the vaccination report card (VRC) to document the presence of any solicited injection-site AEs (pain/tenderness, erythema/redness, and swelling) that occurred in the 5 days after each vaccination. The percentage of participants with a solicited injection-site AE was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Solicited Systemic Adverse Event (AE)</measure>
    <time_frame>Up to 14 days after each vaccination</time_frame>
    <description>Participants used the vaccination report card (VRC) to document the presence of any solicited systemic AEs (headache, fatigue, muscle pain, joint pain) that occurred in the 14 days after each vaccination. The percentage of participants with a solicited systemic AE is reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)</measure>
    <time_frame>Up to 14 days after each vaccination</time_frame>
    <description>An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with an SAE considered to be at least possibly related to the study intervention will be reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb)</measure>
    <time_frame>1 month after third vaccination (at 7 months)</time_frame>
    <description>The NAb GMT in initially CMV-seronegative participants vaccinated with a 3-dose regimen of V160 administered IM was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Viral Detection of V160 in Plasma</measure>
    <time_frame>Day 1 (predose, at dosing, and 3 hours postdose), Day 3, Day 7, and Day 14</time_frame>
    <description>The number of participants with positive viral detection in plasma (defined by viral load in plasma ≥assay defined threshold cutoff value) was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Wild-Type CMV Detection in Urine and Saliva</measure>
    <time_frame>Day 1 (predose), 3, 7, and 14 and Months 2, 6, and 7</time_frame>
    <description>The number of participants with positive wild-type viral shedding in urine or saliva (defined by viral load in saliva/urine ≥ assay defined threshold cutoff value) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab</measure>
    <time_frame>Day 1: 0, 10, 20, and 30 minutes postvaccination</time_frame>
    <description>The number of participants with positive viral leakage in injection-site swab and adhesive tape swab (defined by viral load in injection-site swab/adhesive tape swab ≥ assay defined threshold cutoff value) will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Cytomegalovirus Infections</condition>
  <arm_group>
    <arm_group_label>V160</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive V160 vaccination by IM injection on Day 1, Month 2, and Month 6.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo by IM injection on Day 1, Month 2, and Month 6.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>V160</intervention_name>
    <description>V160 administered as a 0.5 mL (100 Units) IM injection containing 225 mcg aluminum phosphate adjuvant (APA)</description>
    <arm_group_label>V160</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline solution (0.9% sodium chloride [NaCl] administered as a 0.5 mL IM injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy based on medical history and physical examination&#xD;
&#xD;
          -  Serologically confirmed to be CMV seropositive or CMV seronegative at Visit 1&#xD;
&#xD;
          -  If of reproductive potential, agrees to the following from randomization through at&#xD;
             least 4 weeks after the last dose of V160-/placebo (from Day 1 through Month 7): 1)&#xD;
             practice abstinence from heterosexual activity and remain abstinent, or 2) use&#xD;
             contraception unless confirmed to be azoospermic as detailed in the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any allergic reaction or anaphylactic reaction to any vaccine component&#xD;
             that required medical intervention&#xD;
&#xD;
          -  Plans donation of sperm any time from signing the informed consent through 1 month&#xD;
             after receiving the last dose of study drug&#xD;
&#xD;
          -  Is currently immunocompromised or has been diagnosed as having a congenital or&#xD;
             acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma,&#xD;
             leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid&#xD;
             arthritis, inflammatory bowel disease, or other autoimmune condition that requires&#xD;
             immunosuppressive medication.&#xD;
&#xD;
          -  Has a condition in which repeated venipuncture or injections post more than minimal&#xD;
             risk for the participant, such as hemophilia, thrombocytopenia, other severe&#xD;
             coagulation disorders, or significantly impaired venous access&#xD;
&#xD;
          -  Has major psychiatric illness including: any history or schizophrenia or severe&#xD;
             psychosis, bipolar disorder requiring therapy, or suicidal ideation within 3 years.&#xD;
&#xD;
          -  Has previously received any CMV vaccine&#xD;
&#xD;
          -  Had any live virus vaccine administered or scheduled to be administered in the period&#xD;
             from 4 weeks prior to, and 4 weeks following receipt of study drug&#xD;
&#xD;
          -  Had any inactivated vaccine administered or scheduled within the period from 14 days&#xD;
             prior to, through 14 days following study drug&#xD;
&#xD;
          -  Had administration of any immune globulin or blood product within 90 days prior to&#xD;
             injection with study drug or scheduled within 30 days thereafter&#xD;
&#xD;
          -  Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of&#xD;
             prednisone or ≥20 mg/d for persons weighing &gt;10 kg) for ≥14 consecutive days and has&#xD;
             not completed treatment at least 30 days prior to study entry&#xD;
&#xD;
          -  Has received systemic corticosteroids exceeding physiologic replacement doses (≈5 mg/d&#xD;
             prednisone equivalent) within 14 days prior to the first vaccination (participants&#xD;
             using inhaled, nasal, or topical steroids are considered eligible for the study)&#xD;
&#xD;
          -  Has received any anti-viral agent (e.g. letermovir, ganciclovir, valganciclovir,&#xD;
             foscarnet, and valacyclovir) with proven or potential activity against CMV 14 days&#xD;
             prior to vaccination or is likely to receive such an agent within 14 days after&#xD;
             vaccination&#xD;
&#xD;
               -  Receiving or has received in the year prior to enrollment immunosuppressive&#xD;
                  therapies including but not limited to rapamycin (also sirolimus), tacrolimus&#xD;
                  (also FK-506), or other therapies used for solid organ/cell transplant, radiation&#xD;
                  therapy, immunosuppressive/cytotoxic immunotherapy, chemotherapy and other&#xD;
                  immunosuppressive therapies known to interfere with the immune response. Topical&#xD;
                  tacrolimus is allowed provided that it is not used within 14 days prior to, or 14&#xD;
                  days following study drug&#xD;
&#xD;
          -  Has participated in another clinical trial in the past 4 weeks, or plans to&#xD;
             participate in a treatment-based trial or a trial in which an invasive procedure is to&#xD;
             be performed while enrolled in this trial.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Healthy Japanese male participants between the ages of 20 and 64 (inclusive)</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>64 Years</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>
  <location>
    <facility>
      <name>Souseikai PS Clinic ( Site 0001)</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-0025</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <results_reference>
    <citation>Murata S, Oshima N, Iwasa T, Fukao Y, Sawata M. Safety, Tolerability, and Immunogenicity of V160, a Conditionally Replication-Defective Cytomegalovirus Vaccine, in Healthy Japanese Men in a Randomized, Controlled Phase 1 Study. Antibodies (Basel). 2023 Mar 10;12(1):22. doi: 10.3390/antib12010022.</citation>
    <PMID>36975369</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <results_first_submitted>October 15, 2021</results_first_submitted>
  <results_first_submitted_qc>October 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 15, 2021</results_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</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>Cytomegalovirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03840174/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Healthy male participants 20 to 64 years of age were recruited at study sites in Japan.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>V160: CMV Seronegative at Baseline</title>
          <description>Participants who were cytomegalovirus (CMV)-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
        </group>
        <group group_id="P2">
          <title>V160: CMV Seropositive at Baseline</title>
          <description>Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
        </group>
        <group group_id="P3">
          <title>Placebo: CMV Seronegative at Baseline</title>
          <description>Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
        </group>
        <group group_id="P4">
          <title>Placebo: CMV Seropositive at Baseline</title>
          <description>Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 1</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 2</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 3</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>V160: CMV Seropositive at Baseline</title>
          <description>Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
        </group>
        <group group_id="B2">
          <title>Placebo: CMV Seropositive at Baseline</title>
          <description>Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
        </group>
        <group group_id="B3">
          <title>V160: CMV Seronegative at Baseline</title>
          <description>Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
        </group>
        <group group_id="B4">
          <title>Placebo: CMV Seronegative at Baseline</title>
          <description>Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
        </group>
        <group group_id="B5">
          <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="6"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="3"/>
            <count group_id="B5" value="18"/>
          </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="44.8" spread="16.4"/>
                    <measurement group_id="B2" value="36.3" spread="16.0"/>
                    <measurement group_id="B3" value="33.8" spread="11.5"/>
                    <measurement group_id="B4" value="24.7" spread="5.5"/>
                    <measurement group_id="B5" value="36.4" spread="14.3"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Solicited Injection-site Adverse Event (AE)</title>
        <description>Participants used the vaccination report card (VRC) to document the presence of any solicited injection-site AEs (pain/tenderness, erythema/redness, and swelling) that occurred in the 5 days after each vaccination. The percentage of participants with a solicited injection-site AE was reported.</description>
        <time_frame>Up to 5 days after each vaccination</time_frame>
        <population>All randomized participants who received at least 1 vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>V160: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O2">
            <title>V160: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O3">
            <title>Placebo: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
          <group group_id="O4">
            <title>Placebo: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Solicited Injection-site Adverse Event (AE)</title>
          <description>Participants used the vaccination report card (VRC) to document the presence of any solicited injection-site AEs (pain/tenderness, erythema/redness, and swelling) that occurred in the 5 days after each vaccination. The percentage of participants with a solicited injection-site AE was reported.</description>
          <population>All randomized participants who received at least 1 vaccination</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="83.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Solicited Systemic Adverse Event (AE)</title>
        <description>Participants used the vaccination report card (VRC) to document the presence of any solicited systemic AEs (headache, fatigue, muscle pain, joint pain) that occurred in the 14 days after each vaccination. The percentage of participants with a solicited systemic AE is reported.</description>
        <time_frame>Up to 14 days after each vaccination</time_frame>
        <population>All randomized participants who received at least 1 vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>V160: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O2">
            <title>V160: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O3">
            <title>Placebo: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
          <group group_id="O4">
            <title>Placebo: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Solicited Systemic Adverse Event (AE)</title>
          <description>Participants used the vaccination report card (VRC) to document the presence of any solicited systemic AEs (headache, fatigue, muscle pain, joint pain) that occurred in the 14 days after each vaccination. The percentage of participants with a solicited systemic AE is reported.</description>
          <population>All randomized participants who received at least 1 vaccination</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="33.3"/>
                    <measurement group_id="O4" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)</title>
        <description>An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with an SAE considered to be at least possibly related to the study intervention will be reported</description>
        <time_frame>Up to 14 days after each vaccination</time_frame>
        <population>All randomized participants who received at least 1 vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>V160: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O2">
            <title>V160: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O3">
            <title>Placebo: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
          <group group_id="O4">
            <title>Placebo: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)</title>
          <description>An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with an SAE considered to be at least possibly related to the study intervention will be reported</description>
          <population>All randomized participants who received at least 1 vaccination</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb)</title>
        <description>The NAb GMT in initially CMV-seronegative participants vaccinated with a 3-dose regimen of V160 administered IM was assessed.</description>
        <time_frame>1 month after third vaccination (at 7 months)</time_frame>
        <population>All randomized participants who were CMV-seronegative at baseline, received all 3 vaccinations, and did not deviate from the protocol in ways that could affect the immune response</population>
        <group_list>
          <group group_id="O1">
            <title>V160: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O2">
            <title>Placebo: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb)</title>
          <description>The NAb GMT in initially CMV-seronegative participants vaccinated with a 3-dose regimen of V160 administered IM was assessed.</description>
          <population>All randomized participants who were CMV-seronegative at baseline, received all 3 vaccinations, and did not deviate from the protocol in ways that could affect the immune response</population>
          <units>Geometric Mean Titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3651" lower_limit="1688" upper_limit="7895"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="115">Values below the lower limit of titer (&lt;94) are represented by NA.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>77.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.9</ci_lower_limit>
            <ci_upper_limit>252.4</ci_upper_limit>
            <estimate_desc>Geometric Mean Titer (GMT) ratio and 95% CI were estimated using an ANOVA model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Viral Detection of V160 in Plasma</title>
        <description>The number of participants with positive viral detection in plasma (defined by viral load in plasma ≥assay defined threshold cutoff value) was assessed.</description>
        <time_frame>Day 1 (predose, at dosing, and 3 hours postdose), Day 3, Day 7, and Day 14</time_frame>
        <population>All randomized participants who received at least one vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>V160: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O2">
            <title>V160: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O3">
            <title>Placebo: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
          <group group_id="O4">
            <title>Placebo: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Viral Detection of V160 in Plasma</title>
          <description>The number of participants with positive viral detection in plasma (defined by viral load in plasma ≥assay defined threshold cutoff value) was assessed.</description>
          <population>All randomized participants who received at least one vaccination</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (predose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 min postdose in Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 hr postdose in Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Wild-Type CMV Detection in Urine and Saliva</title>
        <description>The number of participants with positive wild-type viral shedding in urine or saliva (defined by viral load in saliva/urine ≥ assay defined threshold cutoff value) will be assessed.</description>
        <time_frame>Day 1 (predose), 3, 7, and 14 and Months 2, 6, and 7</time_frame>
        <population>All randomized participants who received at least one vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>V160: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O2">
            <title>V160: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O3">
            <title>Placebo: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
          <group group_id="O4">
            <title>Placebo: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Wild-Type CMV Detection in Urine and Saliva</title>
          <description>The number of participants with positive wild-type viral shedding in urine or saliva (defined by viral load in saliva/urine ≥ assay defined threshold cutoff value) will be assessed.</description>
          <population>All randomized participants who received at least one vaccination</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (predose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 (postdose [PD] 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 (PD1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 (PD1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2 (predose 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (predose 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 7 (PD3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab</title>
        <description>The number of participants with positive viral leakage in injection-site swab and adhesive tape swab (defined by viral load in injection-site swab/adhesive tape swab ≥ assay defined threshold cutoff value) will be assessed.</description>
        <time_frame>Day 1: 0, 10, 20, and 30 minutes postvaccination</time_frame>
        <population>All randomized participants who received at least one vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>V160: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O2">
            <title>V160: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
          </group>
          <group group_id="O3">
            <title>Placebo: CMV Seronegative at Baseline</title>
            <description>Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
          <group group_id="O4">
            <title>Placebo: CMV Seropositive at Baseline</title>
            <description>Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab</title>
          <description>The number of participants with positive viral leakage in injection-site swab and adhesive tape swab (defined by viral load in injection-site swab/adhesive tape swab ≥ assay defined threshold cutoff value) will be assessed.</description>
          <population>All randomized participants who received at least one vaccination</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Swab from injection-site - 0 min PD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swab from injection-site - 10 min PD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swab from injection-site - 20 min PD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swab from injection-site - 30 min PD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swab from adhesive tape (inside) - 10 min PD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swab from adhesive tape (inside) - 20 min PD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swab from adhesive tape (inside) - 30 min PD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swab from adhesive tape (outside) - 10 min PD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swab from adhesive tape (outside) - 20 min PD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swab from adhesive tape (outside) - 30 min PD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality.</time_frame>
      <desc>All randomized participants who received at least one vaccination are included in safety analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>V160: CMV Seronegative at Baseline</title>
          <description>Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
        </group>
        <group group_id="E2">
          <title>V160: CMV Seropositive at Baseline</title>
          <description>Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.</description>
        </group>
        <group group_id="E3">
          <title>Placebo: CMV Seronegative at Baseline</title>
          <description>Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
        </group>
        <group group_id="E4">
          <title>Placebo: CMV Seropositive at Baseline</title>
          <description>Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 22.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </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 trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.</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/NCT03840174
org study id: V160-003
secondary id: V160-003
secondary id: 194648
nct id: NCT03840174
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160
      administered by intramuscular (IM) injection in healthy Japanese male participants by
      cytomegalovirus (CMV) serostatus. There is no formal hypothesis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
time frame: Up to 5 days after each vaccination
description: Participants used the vaccination report card (VRC) to document the presence of any solicited injection-site AEs (pain/tenderness, erythema/redness, and swelling) that occurred in the 5 days after each vaccination. The percentage of participants with a solicited injection-site AE was reported.
measure: Percentage of Participants With a Solicited Systemic Adverse Event (AE)
time frame: Up to 14 days after each vaccination
description: Participants used the vaccination report card (VRC) to document the presence of any solicited systemic AEs (headache, fatigue, muscle pain, joint pain) that occurred in the 14 days after each vaccination. The percentage of participants with a solicited systemic AE is reported.
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
time frame: Up to 14 days after each vaccination
description: An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with an SAE considered to be at least possibly related to the study intervention will be reported
measure: Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb)
time frame: 1 month after third vaccination (at 7 months)
description: The NAb GMT in initially CMV-seronegative participants vaccinated with a 3-dose regimen of V160 administered IM was assessed.
measure: Number of Participants With Viral Detection of V160 in Plasma
time frame: Day 1 (predose, at dosing, and 3 hours postdose), Day 3, Day 7, and Day 14
description: The number of participants with positive viral detection in plasma (defined by viral load in plasma ≥assay defined threshold cutoff value) was assessed.
measure: Number of Participants With Wild-Type CMV Detection in Urine and Saliva
time frame: Day 1 (predose), 3, 7, and 14 and Months 2, 6, and 7
description: The number of participants with positive wild-type viral shedding in urine or saliva (defined by viral load in saliva/urine ≥ assay defined threshold cutoff value) will be assessed.
measure: Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab
time frame: Day 1: 0, 10, 20, and 30 minutes postvaccination
description: The number of participants with positive viral leakage in injection-site swab and adhesive tape swab (defined by viral load in injection-site swab/adhesive tape swab ≥ assay defined threshold cutoff value) will be assessed.
arm group label: V160
arm group type: Experimental
description: Participants will receive V160 vaccination by IM injection on Day 1, Month 2, and Month 6.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive placebo by IM injection on Day 1, Month 2, and Month 6.
intervention type: Biological
intervention name: V160
description: V160 administered as a 0.5 mL (100 Units) IM injection containing 225 mcg aluminum phosphate adjuvant (APA)
arm group label: V160
intervention type: Other
intervention name: Placebo
description: Saline solution (0.9% sodium chloride [NaCl] administered as a 0.5 mL IM injection
arm group label: Placebo
criteria: 
gender: Male
gender based: Yes
gender description: Healthy Japanese male participants between the ages of 20 and 64 (inclusive)
minimum age: 20 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
facility: 
country: Japan
citation: Murata S, Oshima N, Iwasa T, Fukao Y, Sawata M. Safety, Tolerability, and Immunogenicity of V160, a Conditionally Replication-Defective Cytomegalovirus Vaccine, in Healthy Japanese Men in a Randomized, Controlled Phase 1 Study. Antibodies (Basel). 2023 Mar 10;12(1):22. doi: 10.3390/antib12010022.
PMID: 36975369
responsible party type: Sponsor
mesh term: Cytomegalovirus Infections
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 