<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/NCT03239873</url>
  </required_header>
  <id_info>
    <org_study_id>V210-A03</org_study_id>
    <secondary_id>V210-A03</secondary_id>
    <secondary_id>2017-001910-27</secondary_id>
    <nct_id>NCT03239873</nct_id>
  </id_info>
  <brief_title>Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)</brief_title>
  <official_title>A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34) Process Administered Concomitantly With M-M-R™ II</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella&#xD;
      Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with&#xD;
      the VARIVAX® 2016 commercial process. The primary hypotheses being tested are that antibody&#xD;
      response rate and mean antibody titer induced at 6 weeks after a single vaccination by&#xD;
      VARIVAX® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process,&#xD;
      and that antibody response rate induced by VARIVAX® PE34 Process is acceptable.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2017</start_date>
  <completion_date type="Actual">April 2, 2019</completion_date>
  <primary_completion_date type="Actual">August 14, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL</measure>
    <time_frame>6 weeks (43 days) after vaccination 1</time_frame>
    <description>The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers &lt;1.25 gpELISA units/mL) at baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titer of VZV Antibodies</measure>
    <time_frame>6 weeks (43 days) after vaccination 1</time_frame>
    <description>The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)</measure>
    <time_frame>Up to 42 days after vaccination 1; Up to 42 days after vaccination 2</time_frame>
    <description>The percentage of participants with fever ≥102.2 °F oral equivalent for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence &gt; 0%)</measure>
    <time_frame>Up to 42 days after vaccination 1</time_frame>
    <description>The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence &gt; 0%)</measure>
    <time_frame>Up to 42 days after vaccination 2</time_frame>
    <description>The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1</measure>
    <time_frame>Up to 5 days after vaccination 1</time_frame>
    <description>The percentage of participants with solicited (on a Vaccine Report Card) injection-site erythema, injection-site swelling, or injection-site pain/tenderness was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2</measure>
    <time_frame>Up to 5 days after vaccination 2</time_frame>
    <description>The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With One or More Adverse Events</measure>
    <time_frame>Up to 42 days after vaccination 1 and up to 42 days after vaccination 2</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With One or More Serious Adverse Events</measure>
    <time_frame>Up to ~180 days after vaccination 2 (Up to ~285 days)</time_frame>
    <description>A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAEs ~180 days after vaccination 2 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With One or More Vaccine-Related Adverse Events</measure>
    <time_frame>Up to 42 days after vaccination 1 and up to 42 days after vaccination 2</time_frame>
    <description>The percentage of participants with one or more vaccine-related adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4)</measure>
    <time_frame>Up to 42 days after vaccination 1</time_frame>
    <description>All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 1. The percentage of participants with one or more systemic adverse events (incidence ≥4 participants in one or more of the vaccination groups) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence &gt; 0)</measure>
    <time_frame>Up to 42 days after vaccination 2</time_frame>
    <description>All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 2. The percentage of participants with one or more systemic adverse events was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL)</measure>
    <time_frame>6 weeks (~43 days) after vaccination 1</time_frame>
    <description>The percentage of participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and postvaccination serology contributing to the per-protocol analysis was assessed. Confidence interval is calculated if there are at least 5 subjects who are seropositive. Antibody titers were assessed using gpELISA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody</measure>
    <time_frame>Baseline and 6 weeks (~43 days) after vaccination 1</time_frame>
    <description>Blood samples were taken at pre-vaccination (baseline) and approximately 43 days after vaccination 1 to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The geometric mean fold rise (GMFR) was calculated as GMT post vaccination 1/GMT pre-vaccination (baseline). Confidence interval is calculated if there are at least 5 subjects who are seropositive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody</measure>
    <time_frame>Baseline and 6 weeks (~43 days) after vaccination 1</time_frame>
    <description>The percentage of participants with a geometric mean ≥4-fold rise from baseline of ≥1.25gpELISA units/mL in VZV antibody titer at approximately 43 days after vaccination 1 was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With One or More Vaccine-Related Serious Adverse Events</measure>
    <time_frame>Up to ~180 days after vaccination 2</time_frame>
    <description>The percentage of participants with one or more vaccine-related serious adverse events up to ~180 days after vaccination 2 was reported. The study investigator determines whether the serious adverse event is related to the vaccine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event</measure>
    <time_frame>Up to 42 days after vaccination 1 and up to 42 days after vaccination 2</time_frame>
    <description>The percentage of participants discontinued from the study due to an adverse event for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence &gt; 0%)</measure>
    <time_frame>Up to 42 days after vaccination 1</time_frame>
    <description>The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence &gt; 0%)</measure>
    <time_frame>Up to 42 days after vaccination 2</time_frame>
    <description>The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%)</measure>
    <time_frame>Up to ~180 days after vaccination 2 (Up to ~285 days)</time_frame>
    <description>The percentage of participants with medically-attended AEs up to ~180 days after vaccination 2 that did not meet the definition of serious adverse event (incidence ≥5% in one or more vaccination groups) was reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Varicella</condition>
  <arm_group>
    <arm_group_label>VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VARIVAX® Passage Extension (PE34) Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VARIVAX® 2016 Commercial Process + M-M-R II®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VARIVAX® 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VARIVAX® PE34 Process</intervention_name>
    <description>Varicella virus vaccine live manufactured with a new passage extension process (PE34)</description>
    <arm_group_label>VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VARIVAX® 2016 Commercial Process</intervention_name>
    <description>Varicella virus vaccine live manufactured with the 2016 commercial process</description>
    <arm_group_label>VARIVAX® 2016 Commercial Process + M-M-R II®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>M-M-R II®</intervention_name>
    <description>Measles, Mumps, and Rubella virus vaccine live</description>
    <arm_group_label>VARIVAX® 2016 Commercial Process + M-M-R II®</arm_group_label>
    <arm_group_label>VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received any measles, mumps, rubella, or varicella vaccine at any time prior to the&#xD;
             study, or is anticipated to receive any of these vaccines outside the study&#xD;
&#xD;
          -  Any congenital or acquired immune deficiency, neoplastic disease, or depressed&#xD;
             immunity&#xD;
&#xD;
          -  Received systemic immunomodulatory steroids within 3 months prior to entering the&#xD;
             study or is expected to receive them during the course of the study&#xD;
&#xD;
          -  History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg&#xD;
             proteins, chicken proteins, or any component of VARIVAX® or M-M-R II®&#xD;
&#xD;
          -  Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting&#xD;
             the bone marrow or lymphatic systems&#xD;
&#xD;
          -  Received salicylates within 14 days prior to study vaccination&#xD;
&#xD;
          -  Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior&#xD;
             to study vaccination&#xD;
&#xD;
          -  Received immune globulin, a blood transfusion, or blood-derived products within 5&#xD;
             months prior to study vaccination&#xD;
&#xD;
          -  History of seizure disorder, including febrile seizure&#xD;
&#xD;
          -  Fever illness (&gt;=102.2 °F [39.0 °C] within 72 hours prior to study vaccination&#xD;
&#xD;
          -  History of thrombocytopenia&#xD;
&#xD;
          -  Born to a human immunodeficiency virus (HIV)-infected mother&#xD;
&#xD;
          -  Has a diagnosis of active untreated tuberculosis&#xD;
&#xD;
          -  Participated in any other clinical trial (other than a surveillance study) within 30&#xD;
             days prior to study enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>23 Months</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>Alabama Clinical Therapeutics ( Site 0018)</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Clinic of Jonesboro, PA ( Site 0030)</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southland Clinical Research Center ( Site 0017)</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Health Research Center, LLC ( Site 0044)</name>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Research Foundation ( Site 0003)</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMMUNOe Research Centers ( Site 0046)</name>
      <address>
        <city>Thornton</city>
        <state>Colorado</state>
        <zip>80233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Research at Altamonte Pediatric Associates ( Site 0040)</name>
      <address>
        <city>Lake Mary</city>
        <state>Florida</state>
        <zip>32746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida ( Site 0042)</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research ( Site 0038)</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates, LLC ( Site 0029)</name>
      <address>
        <city>Augusta</city>
        <state>Kansas</state>
        <zip>67010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates, LLC ( Site 0015)</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cotton O'Neil Research Center ( Site 0014)</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentucky Pediatric/Adult Research Inc ( Site 0012)</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville: Pediatric Clinical Trials Unit ( Site 0025)</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ACC Pediatric Research ( Site 0041)</name>
      <address>
        <city>Haughton</city>
        <state>Louisiana</state>
        <zip>71037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center For Pharmaceutical Research PC ( Site 0011)</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Child Health Care Associates ( Site 0045)</name>
      <address>
        <city>East Syracuse</city>
        <state>New York</state>
        <zip>13057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blue Ridge Pediatric &amp; Adolescent Medicine ( Site 0001)</name>
      <address>
        <city>Boone</city>
        <state>North Carolina</state>
        <zip>28607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ford, Simpson, Lively &amp; Rice Pediatrics, PLLC ( Site 0037)</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senders Pediatrics ( Site 0034)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Pediatric Research Association ( Site 0035)</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kid's Way Pediatrics ( Site 0047)</name>
      <address>
        <city>Hermitage</city>
        <state>Pennsylvania</state>
        <zip>16148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Pediatrics, PA ( Site 0023)</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Pediatric Research ( Site 0006)</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holston Medical Group Pediatrics ( Site 0024)</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research ( Site 0005)</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch at Galveston ( Site 0032)</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Houston Clinical Research Services ( Site 0009)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Healthcare of Northwest Houston ( Site 0027)</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tanner Clinic ( Site 0010)</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wee Care Pediatrics-Roy ( Site 0043)</name>
      <address>
        <city>Roy</city>
        <state>Utah</state>
        <zip>84067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J Lewis Research Inc / Foothill Family Clinic ( Site 0016)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J Lewis Research Inc/Foothill Family Clinic South ( Site 0004)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J Lewis Research Inc/Jordan River Family Medicine ( Site 0019)</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wee Care Pediatrics ( Site 0036)</name>
      <address>
        <city>Syracuse</city>
        <state>Utah</state>
        <zip>84075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research ( Site 0020)</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Research of Charlottesville, LLC ( Site 0039)</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Silas PE, Zissman EN, Gardner J, Helian S, Lee AW, Platt HL. A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R II). Hum Vaccin Immunother. 2020 Nov 1;16(11):2634-2640. doi: 10.1080/21645515.2020.1743122. Epub 2020 May 19.</citation>
    <PMID>32429738</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <results_first_submitted>August 8, 2019</results_first_submitted>
  <results_first_submitted_qc>August 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 26, 2019</results_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chickenpox</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>October 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03239873/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>VARIVAX PE34 + M-M-R II</title>
          <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
        </group>
        <group group_id="P2">
          <title>VARIVAX (2016 CP) + M-M-R II</title>
          <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="300"/>
                <participants group_id="P2" count="300"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 1</title>
              <participants_list>
                <participants group_id="P1" count="299"/>
                <participants group_id="P2" count="300"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 2</title>
              <participants_list>
                <participants group_id="P1" count="276"/>
                <participants group_id="P2" count="282"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="268"/>
                <participants group_id="P2" count="273"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Parent/Guardian</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Contraindication to study medication</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>VARIVAX PE34 + M-M-R II</title>
          <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
        </group>
        <group group_id="B2">
          <title>VARIVAX (2016 CP) + M-M-R II</title>
          <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</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="300"/>
            <count group_id="B2" value="300"/>
            <count group_id="B3" value="600"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.0" spread="1.4"/>
                    <measurement group_id="B2" value="13.2" spread="1.7"/>
                    <measurement group_id="B3" value="13.1" spread="1.6"/>
                  </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="153"/>
                    <measurement group_id="B2" value="127"/>
                    <measurement group_id="B3" value="280"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="173"/>
                    <measurement group_id="B3" value="320"/>
                  </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="46"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="254"/>
                    <measurement group_id="B2" value="237"/>
                    <measurement group_id="B3" value="491"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="237"/>
                    <measurement group_id="B2" value="239"/>
                    <measurement group_id="B3" value="476"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="54"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL</title>
        <description>The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers &lt;1.25 gpELISA units/mL) at baseline.</description>
        <time_frame>6 weeks (43 days) after vaccination 1</time_frame>
        <population>The analysis population included the number of participants with seronegative antibody titer (&lt;1.25 gpELISA units/mL) at baseline and postvaccination serology.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL</title>
          <description>The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers &lt;1.25 gpELISA units/mL) at baseline.</description>
          <population>The analysis population included the number of participants with seronegative antibody titer (&lt;1.25 gpELISA units/mL) at baseline and postvaccination serology.</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="245"/>
                <count group_id="O2" value="239"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.4" lower_limit="95.9" upper_limit="99.6"/>
                    <measurement group_id="O2" value="98.3" lower_limit="95.8" upper_limit="99.5"/>
                  </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>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.7</ci_lower_limit>
            <ci_upper_limit>2.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being &gt;76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Acceptability</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Exact CI method/binomial proportion</method>
            <param_type>Antibody Response Rate</param_type>
            <param_value>98.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>95.9</ci_lower_limit>
            <ci_upper_limit>99.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titer of VZV Antibodies</title>
        <description>The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.</description>
        <time_frame>6 weeks (43 days) after vaccination 1</time_frame>
        <population>The analysis population included the number of participants with seronegative antibody titer (&lt;1.25 gpELISA units/mL) at baseline and postvaccination serology.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of VZV Antibodies</title>
          <description>The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.</description>
          <population>The analysis population included the number of participants with seronegative antibody titer (&lt;1.25 gpELISA units/mL) at baseline and postvaccination serology.</population>
          <units>gpELISA units/mL</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="245"/>
                <count group_id="O2" value="239"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.5" lower_limit="17.1" upper_limit="20.1"/>
                    <measurement group_id="O2" value="19.0" lower_limit="17.6" upper_limit="20.5"/>
                  </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>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The statistical criterion for noninferiority of the GMT corresponds to the lower bound of the 2-sided 95% CI on the GMT ratio [VARIVAX® PE34 process/VARIVAX® 2016 commercial product] being &gt;0.67.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>1.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)</title>
        <description>The percentage of participants with fever ≥102.2 °F oral equivalent for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
        <time_frame>Up to 42 days after vaccination 1; Up to 42 days after vaccination 2</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with temperature data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)</title>
          <description>The percentage of participants with fever ≥102.2 °F oral equivalent for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with temperature data at the time of assessment.</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="299"/>
                <count group_id="O2" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Up to 42 days after Vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="299"/>
                    <count group_id="O2" value="300"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                    <measurement group_id="O2" value="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Up to 42 days after Vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="282"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9"/>
                    <measurement group_id="O2" value="6.1"/>
                  </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>
            <groups_desc>Up to 42 days after Vaccination 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.436</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.1</ci_lower_limit>
            <ci_upper_limit>7.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Up to 42 days after Vaccination 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.204</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>7.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence &gt; 0%)</title>
        <description>The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
        <time_frame>Up to 42 days after vaccination 1</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence &gt; 0%)</title>
          <description>The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="299"/>
                <count group_id="O2" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Measles-like rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rubella-like rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Varicella-like rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                    <measurement group_id="O2" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Zoster-like rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.3"/>
                  </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>
            <groups_desc>Measles-like rash</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.102</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>-1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.5</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Rubella-like rash</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.317</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>1.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Varicella-like rash</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.241</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>4.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Zoster-like rash</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.318</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence &gt; 0%)</title>
        <description>The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
        <time_frame>Up to 42 days after vaccination 2</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence &gt; 0%)</title>
          <description>The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="276"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Measles-like rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Varicella-like rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Zoster-like rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="0.0"/>
                  </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>
            <groups_desc>Measles-like rash</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.170</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>3.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Varicella-like rash</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.576</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.2</ci_lower_limit>
            <ci_upper_limit>1.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Zoster-like rash</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.312</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1</title>
        <description>The percentage of participants with solicited (on a Vaccine Report Card) injection-site erythema, injection-site swelling, or injection-site pain/tenderness was assessed.</description>
        <time_frame>Up to 5 days after vaccination 1</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1</title>
          <description>The percentage of participants with solicited (on a Vaccine Report Card) injection-site erythema, injection-site swelling, or injection-site pain/tenderness was assessed.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="299"/>
                <count group_id="O2" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection site erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7"/>
                    <measurement group_id="O2" value="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4"/>
                    <measurement group_id="O2" value="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0"/>
                    <measurement group_id="O2" value="5.7"/>
                  </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>
            <groups_desc>Injection site erythema</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.696</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference of Percentage</param_type>
            <param_value>-1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.9</ci_lower_limit>
            <ci_upper_limit>4.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Injection site pain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.796</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.7</ci_lower_limit>
            <ci_upper_limit>6.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Injection site swelling</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.111</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>-2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-6.2</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2</title>
        <description>The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness was assessed.</description>
        <time_frame>Up to 5 days after vaccination 2</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2</title>
          <description>The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness was assessed.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="276"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection site erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.6"/>
                    <measurement group_id="O2" value="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7"/>
                    <measurement group_id="O2" value="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1"/>
                    <measurement group_id="O2" value="8.2"/>
                  </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>
            <groups_desc>Injection site erythema</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.931</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.9</ci_lower_limit>
            <ci_upper_limit>6.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Injection site pain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.523</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>-1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.6</ci_lower_limit>
            <ci_upper_limit>3.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Injection site swelling</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.415</p_value>
            <method>Miettinen &amp; Nurminen</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.9</ci_lower_limit>
            <ci_upper_limit>6.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With One or More Adverse Events</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
        <time_frame>Up to 42 days after vaccination 1 and up to 42 days after vaccination 2</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With One or More Adverse Events</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="299"/>
                <count group_id="O2" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0"/>
                    <measurement group_id="O2" value="88.3"/>
                  </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>Difference in Percentage</param_type>
            <param_value>1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.4</ci_lower_limit>
            <ci_upper_limit>6.7</ci_upper_limit>
            <estimate_desc>Miettinen &amp; Nurminen</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With One or More Serious Adverse Events</title>
        <description>A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAEs ~180 days after vaccination 2 was reported.</description>
        <time_frame>Up to ~180 days after vaccination 2 (Up to ~285 days)</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With One or More Serious Adverse Events</title>
          <description>A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAEs ~180 days after vaccination 2 was reported.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="299"/>
                <count group_id="O2" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                    <measurement group_id="O2" value="2.0"/>
                  </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>Difference in Percentage</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.5</ci_lower_limit>
            <ci_upper_limit>2.6</ci_upper_limit>
            <estimate_desc>Miettinen &amp; Nurminen</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With One or More Vaccine-Related Adverse Events</title>
        <description>The percentage of participants with one or more vaccine-related adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
        <time_frame>Up to 42 days after vaccination 1 and up to 42 days after vaccination 2</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With One or More Vaccine-Related Adverse Events</title>
          <description>The percentage of participants with one or more vaccine-related adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="299"/>
                <count group_id="O2" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.2"/>
                    <measurement group_id="O2" value="54.3"/>
                  </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>Difference in Percentage</param_type>
            <param_value>1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.1</ci_lower_limit>
            <ci_upper_limit>9.8</ci_upper_limit>
            <estimate_desc>Miettinen &amp; Nurminen</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4)</title>
        <description>All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 1. The percentage of participants with one or more systemic adverse events (incidence ≥4 participants in one or more of the vaccination groups) was reported.</description>
        <time_frame>Up to 42 days after vaccination 1</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4)</title>
          <description>All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 1. The percentage of participants with one or more systemic adverse events (incidence ≥4 participants in one or more of the vaccination groups) was reported.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="299"/>
                <count group_id="O2" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.6"/>
                    <measurement group_id="O2" value="74.3"/>
                  </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>Difference in Percentage</param_type>
            <param_value>2.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.7</ci_lower_limit>
            <ci_upper_limit>9.2</ci_upper_limit>
            <estimate_desc>Miettinen &amp; Nurminen</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence &gt; 0)</title>
        <description>All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 2. The percentage of participants with one or more systemic adverse events was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
        <time_frame>Up to 42 days after vaccination 2</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence &gt; 0)</title>
          <description>All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 2. The percentage of participants with one or more systemic adverse events was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="276"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.9"/>
                    <measurement group_id="O2" value="59.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL)</title>
        <description>The percentage of participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and postvaccination serology contributing to the per-protocol analysis was assessed. Confidence interval is calculated if there are at least 5 subjects who are seropositive. Antibody titers were assessed using gpELISA.</description>
        <time_frame>6 weeks (~43 days) after vaccination 1</time_frame>
        <population>The analysis population consisted of all participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and with available postvaccination serology data.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL)</title>
          <description>The percentage of participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and postvaccination serology contributing to the per-protocol analysis was assessed. Confidence interval is calculated if there are at least 5 subjects who are seropositive. Antibody titers were assessed using gpELISA.</description>
          <population>The analysis population consisted of all participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and with available postvaccination serology data.</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="31"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="97.5" lower_limit="86.8" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody</title>
        <description>Blood samples were taken at pre-vaccination (baseline) and approximately 43 days after vaccination 1 to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The geometric mean fold rise (GMFR) was calculated as GMT post vaccination 1/GMT pre-vaccination (baseline). Confidence interval is calculated if there are at least 5 subjects who are seropositive.</description>
        <time_frame>Baseline and 6 weeks (~43 days) after vaccination 1</time_frame>
        <population>The analysis population consisted of all participants with with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and with available postvaccination serology data.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody</title>
          <description>Blood samples were taken at pre-vaccination (baseline) and approximately 43 days after vaccination 1 to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The geometric mean fold rise (GMFR) was calculated as GMT post vaccination 1/GMT pre-vaccination (baseline). Confidence interval is calculated if there are at least 5 subjects who are seropositive.</description>
          <population>The analysis population consisted of all participants with with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and with available postvaccination serology data.</population>
          <units>Ratio</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="31"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="5.0" upper_limit="8.5"/>
                    <measurement group_id="O2" value="7.2" lower_limit="5.9" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody</title>
        <description>The percentage of participants with a geometric mean ≥4-fold rise from baseline of ≥1.25gpELISA units/mL in VZV antibody titer at approximately 43 days after vaccination 1 was assessed.</description>
        <time_frame>Baseline and 6 weeks (~43 days) after vaccination 1</time_frame>
        <population>The analysis population consisted of all participants with seropositive antibody titer (≥1.25gpELISA units/mL) and available postvaccination serology data.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody</title>
          <description>The percentage of participants with a geometric mean ≥4-fold rise from baseline of ≥1.25gpELISA units/mL in VZV antibody titer at approximately 43 days after vaccination 1 was assessed.</description>
          <population>The analysis population consisted of all participants with seropositive antibody titer (≥1.25gpELISA units/mL) and available postvaccination serology data.</population>
          <units>Percentage of Participants</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="31"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.6" lower_limit="62.5" upper_limit="92.5"/>
                    <measurement group_id="O2" value="82.5" lower_limit="67.2" upper_limit="92.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With One or More Vaccine-Related Serious Adverse Events</title>
        <description>The percentage of participants with one or more vaccine-related serious adverse events up to ~180 days after vaccination 2 was reported. The study investigator determines whether the serious adverse event is related to the vaccine.</description>
        <time_frame>Up to ~180 days after vaccination 2</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With One or More Vaccine-Related Serious Adverse Events</title>
          <description>The percentage of participants with one or more vaccine-related serious adverse events up to ~180 days after vaccination 2 was reported. The study investigator determines whether the serious adverse event is related to the vaccine.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="299"/>
                <count group_id="O2" value="300"/>
              </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_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>Difference in Percentage</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>1.3</ci_upper_limit>
            <estimate_desc>Miettinen &amp; Nurminen</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event</title>
        <description>The percentage of participants discontinued from the study due to an adverse event for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
        <time_frame>Up to 42 days after vaccination 1 and up to 42 days after vaccination 2</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event</title>
          <description>The percentage of participants discontinued from the study due to an adverse event for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="299"/>
                <count group_id="O2" value="300"/>
              </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_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>Difference in Percentage</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>1.3</ci_upper_limit>
            <estimate_desc>Miettinen &amp; Nurminen</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence &gt; 0%)</title>
        <description>The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
        <time_frame>Up to 42 days after vaccination 1</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence &gt; 0%)</title>
          <description>The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="299"/>
                <count group_id="O2" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0"/>
                    <measurement group_id="O2" value="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence &gt; 0%)</title>
        <description>The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
        <time_frame>Up to 42 days after vaccination 2</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence &gt; 0%)</title>
          <description>The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was &gt;0% in one or more vaccination groups after rounding.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</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="276"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%)</title>
        <description>The percentage of participants with medically-attended AEs up to ~180 days after vaccination 2 that did not meet the definition of serious adverse event (incidence ≥5% in one or more vaccination groups) was reported.</description>
        <time_frame>Up to ~180 days after vaccination 2 (Up to ~285 days)</time_frame>
        <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>VARIVAX PE34 + M-M-R II</title>
            <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
          <group group_id="O2">
            <title>VARIVAX (2016 CP) + M-M-R II</title>
            <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%)</title>
          <description>The percentage of participants with medically-attended AEs up to ~180 days after vaccination 2 that did not meet the definition of serious adverse event (incidence ≥5% in one or more vaccination groups) was reported.</description>
          <population>The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.</population>
          <units>Percentge of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5"/>
                    <measurement group_id="O2" value="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.6</ci_lower_limit>
            <ci_upper_limit>10.3</ci_upper_limit>
            <estimate_desc>Miettinen and Nurminen</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.</time_frame>
      <desc>The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>VARIVAX PE34 + M-M-R II</title>
          <description>VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
        </group>
        <group group_id="E2">
          <title>VARIVAX (2016 CP) + M-M-R II</title>
          <description>2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="299"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Adenovirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="299"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Enterovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pharyngeal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</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="255" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="240" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="40" subjects_affected="35" subjects_at_risk="299"/>
                <counts group_id="E2" events="78" subjects_affected="65" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Teething</sub_title>
                <counts group_id="E1" events="34" subjects_affected="27" subjects_at_risk="299"/>
                <counts group_id="E2" events="63" subjects_affected="50" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="40" subjects_affected="36" subjects_at_risk="299"/>
                <counts group_id="E2" events="47" subjects_affected="42" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="299"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="158" subjects_affected="85" subjects_at_risk="299"/>
                <counts group_id="E2" events="157" subjects_affected="87" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="129" subjects_affected="55" subjects_at_risk="299"/>
                <counts group_id="E2" events="125" subjects_affected="59" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="66" subjects_affected="47" subjects_at_risk="299"/>
                <counts group_id="E2" events="64" subjects_affected="43" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="134" subjects_affected="97" subjects_at_risk="299"/>
                <counts group_id="E2" events="111" subjects_affected="75" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" events="18" subjects_affected="17" subjects_at_risk="299"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="38" subjects_affected="33" subjects_at_risk="299"/>
                <counts group_id="E2" events="49" subjects_affected="44" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="41" subjects_affected="35" subjects_at_risk="299"/>
                <counts group_id="E2" events="29" subjects_affected="26" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="299"/>
                <counts group_id="E2" events="29" subjects_affected="27" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="41" subjects_affected="37" subjects_at_risk="299"/>
                <counts group_id="E2" events="58" subjects_affected="49" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="74" subjects_affected="50" subjects_at_risk="299"/>
                <counts group_id="E2" events="70" subjects_affected="51" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="66" subjects_affected="53" subjects_at_risk="299"/>
                <counts group_id="E2" events="68" subjects_affected="56" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="33" subjects_affected="26" subjects_at_risk="299"/>
                <counts group_id="E2" events="30" subjects_affected="20" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="76" subjects_affected="48" subjects_at_risk="299"/>
                <counts group_id="E2" events="50" subjects_affected="44" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="46" subjects_affected="39" subjects_at_risk="299"/>
                <counts group_id="E2" events="44" subjects_affected="33" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="38" subjects_affected="25" subjects_at_risk="299"/>
                <counts group_id="E2" events="37" subjects_affected="27" subjects_at_risk="300"/>
              </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. Sponsor review can be expedited to meet publication timelines.</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/NCT03239873
org study id: V210-A03
secondary id: V210-A03
secondary id: 2017-001910-27
nct id: NCT03239873
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella
      Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with
      the VARIVAX® 2016 commercial process. The primary hypotheses being tested are that antibody
      response rate and mean antibody titer induced at 6 weeks after a single vaccination by
      VARIVAX® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process,
      and that antibody response rate induced by VARIVAX® PE34 Process is acceptable.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
time frame: 6 weeks (43 days) after vaccination 1
description: The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers <1.25 gpELISA units/mL) at baseline.
measure: Geometric Mean Titer of VZV Antibodies
time frame: 6 weeks (43 days) after vaccination 1
description: The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.
measure: Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)
time frame: Up to 42 days after vaccination 1; Up to 42 days after vaccination 2
description: The percentage of participants with fever ≥102.2 °F oral equivalent for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
measure: Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)
time frame: Up to 42 days after vaccination 1
description: The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
measure: Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%)
time frame: Up to 42 days after vaccination 2
description: The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
measure: Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1
time frame: Up to 5 days after vaccination 1
description: The percentage of participants with solicited (on a Vaccine Report Card) injection-site erythema, injection-site swelling, or injection-site pain/tenderness was assessed.
measure: Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
time frame: Up to 5 days after vaccination 2
description: The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness was assessed.
measure: Percentage of Participants With One or More Adverse Events
time frame: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
description: An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
measure: Percentage of Participants With One or More Serious Adverse Events
time frame: Up to ~180 days after vaccination 2 (Up to ~285 days)
description: A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAEs ~180 days after vaccination 2 was reported.
measure: Percentage of Participants With One or More Vaccine-Related Adverse Events
time frame: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
description: The percentage of participants with one or more vaccine-related adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
measure: Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4)
time frame: Up to 42 days after vaccination 1
description: All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 1. The percentage of participants with one or more systemic adverse events (incidence ≥4 participants in one or more of the vaccination groups) was reported.
measure: Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence > 0)
time frame: Up to 42 days after vaccination 2
description: All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 2. The percentage of participants with one or more systemic adverse events was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
measure: Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL)
time frame: 6 weeks (~43 days) after vaccination 1
description: The percentage of participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and postvaccination serology contributing to the per-protocol analysis was assessed. Confidence interval is calculated if there are at least 5 subjects who are seropositive. Antibody titers were assessed using gpELISA.
measure: Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody
time frame: Baseline and 6 weeks (~43 days) after vaccination 1
description: Blood samples were taken at pre-vaccination (baseline) and approximately 43 days after vaccination 1 to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The geometric mean fold rise (GMFR) was calculated as GMT post vaccination 1/GMT pre-vaccination (baseline). Confidence interval is calculated if there are at least 5 subjects who are seropositive.
measure: Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody
time frame: Baseline and 6 weeks (~43 days) after vaccination 1
description: The percentage of participants with a geometric mean ≥4-fold rise from baseline of ≥1.25gpELISA units/mL in VZV antibody titer at approximately 43 days after vaccination 1 was assessed.
measure: Percentage of Participants With One or More Vaccine-Related Serious Adverse Events
time frame: Up to ~180 days after vaccination 2
description: The percentage of participants with one or more vaccine-related serious adverse events up to ~180 days after vaccination 2 was reported. The study investigator determines whether the serious adverse event is related to the vaccine.
measure: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
time frame: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2
description: The percentage of participants discontinued from the study due to an adverse event for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
measure: Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence > 0%)
time frame: Up to 42 days after vaccination 1
description: The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
measure: Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence > 0%)
time frame: Up to 42 days after vaccination 2
description: The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.
measure: Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%)
time frame: Up to ~180 days after vaccination 2 (Up to ~285 days)
description: The percentage of participants with medically-attended AEs up to ~180 days after vaccination 2 that did not meet the definition of serious adverse event (incidence ≥5% in one or more vaccination groups) was reported.
arm group label: VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®
arm group type: Experimental
description: VARIVAX® Passage Extension (PE34) Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91
arm group label: VARIVAX® 2016 Commercial Process + M-M-R II®
arm group type: Active Comparator
description: VARIVAX® 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91
intervention type: Biological
intervention name: VARIVAX® PE34 Process
description: Varicella virus vaccine live manufactured with a new passage extension process (PE34)
arm group label: VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®
intervention type: Biological
intervention name: VARIVAX® 2016 Commercial Process
description: Varicella virus vaccine live manufactured with the 2016 commercial process
arm group label: VARIVAX® 2016 Commercial Process + M-M-R II®
intervention type: Biological
intervention name: M-M-R II®
description: Measles, Mumps, and Rubella virus vaccine live
arm group label: VARIVAX® 2016 Commercial Process + M-M-R II®
arm group label: VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®
criteria: 
gender: All
minimum age: 12 Months
maximum age: 23 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
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country: United States
citation: Silas PE, Zissman EN, Gardner J, Helian S, Lee AW, Platt HL. A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R II). Hum Vaccin Immunother. 2020 Nov 1;16(11):2634-2640. doi: 10.1080/21645515.2020.1743122. Epub 2020 May 19.
PMID: 32429738
responsible party type: Sponsor
mesh term: Chickenpox
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: 