<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/NCT03780179</url>
  </required_header>
  <id_info>
    <org_study_id>LGS.MMR.01.2016.2022</org_study_id>
    <nct_id>NCT03780179</nct_id>
  </id_info>
  <brief_title>MMR at 6 Months Trial</brief_title>
  <official_title>Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomised, double-blind clinical trial to test humoral and cellular immunogenicity, and&#xD;
      potential in-direct beneficial effect of the MMRvaxpro-vaccine administered at 6 months of&#xD;
      age&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">January 7, 2022</completion_date>
  <primary_completion_date type="Actual">January 7, 2022</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Humoral immunogenicity</measure>
    <time_frame>1 months after intervention</time_frame>
    <description>The plaque reduction neutralisation test (PRNT), which measures the serum dilution capable of preventing 50% of plaque formation induced by measles virus in cell cultures, has been considered the most reliable criterion for the serologic evaluation of measles immunity. For PNRT, the protective cutoff titer is defined to be &gt;120. A frequency of 95% seroconversion rate, i.e. children mounting a protective level of humoral immunity according to the abovementioned cutoff value after MMR-vaccination at 6 M of age will be considered sufficient to suggest implementation of MMR at 6 M in the Danish vaccination programme.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospitalisation for infection</measure>
    <time_frame>6-12 months of age</time_frame>
    <description>Significant decrease in hospitalisation for infection measured as repeated events from 6 to 12 months of age in children randomised to MMR at 6 M compared to children randomised to placebo. Information about hospitalisation for infection will be obtained from the national Danish Patient Register, where all Danish inhabitants are followed-up during all hospital contacts.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6540</enrollment>
  <condition>Meales-mumps-rubella Vaccine</condition>
  <arm_group>
    <arm_group_label>MMRvaxpro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MMRvaxpro</intervention_name>
    <description>MMRvaxpro vaccine</description>
    <arm_group_label>MMRvaxpro</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age of 32+ weeks.&#xD;
&#xD;
          -  Birth weight of 1000+ grams.&#xD;
&#xD;
          -  Signed informed consent from the parents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immune-deficiency (primary or acquired) or -suppression.&#xD;
&#xD;
          -  Intake of immune modulating medicine (including high doses of corticosteroids)&#xD;
             (M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or&#xD;
             low-dose parenteral corticosteroids, e.g. for asthma prophylaxis or replacement&#xD;
             therapy).&#xD;
&#xD;
          -  Signs of severe illness or major malformation.&#xD;
&#xD;
          -  No Danish-speaking parent.&#xD;
&#xD;
          -  Children with a history of anaphylactic, anaphylactoid, or other immediate reactions&#xD;
             (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or&#xD;
             shock) subsequent to egg ingestion are excluded.&#xD;
&#xD;
          -  Children with known fructose intolerance, thrombocytopenia or any coagulation disorder&#xD;
             will be excluded.&#xD;
&#xD;
          -  Children who received blood or plasma transfusions, or administration of human immune&#xD;
             serum globulin within the last 3 months will be excluded.&#xD;
&#xD;
          -  Further, children are excluded from the trial if any contraindication is suspected:&#xD;
             history of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of&#xD;
             the excipients, including neomycin.&#xD;
&#xD;
          -  Children with active untreated tuberculosis, blood dyscrasias, leukaemia, lymphomas of&#xD;
             any type, or other malignant neoplasms affecting the haematopoietic and lymphatic&#xD;
             systems will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Months</minimum_age>
    <maximum_age>7 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <state>Copenhagen Ø</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 12, 2022</last_update_submitted>
  <last_update_submitted_qc>January 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Lone Graff Stensballe</investigator_full_name>
    <investigator_title>Pediatrician, associate professor, PhD</investigator_title>
  </responsible_party>
  <keyword>measles-mumps-rubella vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rubella</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03780179
org study id: LGS.MMR.01.2016.2022
nct id: NCT03780179
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Randomised, double-blind clinical trial to test humoral and cellular immunogenicity, and
      potential in-direct beneficial effect of the MMRvaxpro-vaccine administered at 6 months of
      age
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Humoral immunogenicity
time frame: 1 months after intervention
description: The plaque reduction neutralisation test (PRNT), which measures the serum dilution capable of preventing 50% of plaque formation induced by measles virus in cell cultures, has been considered the most reliable criterion for the serologic evaluation of measles immunity. For PNRT, the protective cutoff titer is defined to be >120. A frequency of 95% seroconversion rate, i.e. children mounting a protective level of humoral immunity according to the abovementioned cutoff value after MMR-vaccination at 6 M of age will be considered sufficient to suggest implementation of MMR at 6 M in the Danish vaccination programme.
measure: Hospitalisation for infection
time frame: 6-12 months of age
description: Significant decrease in hospitalisation for infection measured as repeated events from 6 to 12 months of age in children randomised to MMR at 6 M compared to children randomised to placebo. Information about hospitalisation for infection will be obtained from the national Danish Patient Register, where all Danish inhabitants are followed-up during all hospital contacts.
arm group label: MMRvaxpro
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Biological
intervention name: MMRvaxpro
description: MMRvaxpro vaccine
arm group label: MMRvaxpro
intervention type: Biological
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 5 Months
maximum age: 7 Months
healthy volunteers: No
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Lone Graff Stensballe
investigator title: Pediatrician, associate professor, PhD
mesh term: Rubella