xml: <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/NCT06011200</url>
    </required_header>
    <id_info>
      <org_study_id>CTP-MCVF-002</org_study_id>
      <nct_id>NCT06011200</nct_id>
    </id_info>
    <brief_title>A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a 4 to 6 Year-old Population</brief_title>
    <official_title>A Randomized, Blinded, Comparable Vaccine-controlled Phase IIIb Clinical Trial to Evaluate the Safety and Immunogenicity of Meningococcal Polysaccharide Conjugate Vaccine, Group ACYW135 (CRM197 Vector), in a 4 to 6 Year-old Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CanSino Biologics Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CanSino Biologics Inc.</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The scientific name of meningococcus is Neisseria meningitidis (Nm), the causative agent of&#xD;
        epidemic meningococcal meningitis (rheumatoid encephalitis), which colonizes the mucous&#xD;
        membranes of the human nasopharynx or causes local infection and can cross the mucosal&#xD;
        barrier to cause invasive bacteremia or epidemic meningococcal meningitis, meningococcus can&#xD;
        often cause serious disease epidemics worldwide, the main clinical features of its infection&#xD;
        are fever, rash and meningitis, the most common clinical manifestation is acute bacterial&#xD;
        meningitis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The preventive measures for influenza are based on strengthening personal protection,&#xD;
        vaccination, strengthening surveillance, early detection of patients, and active isolation&#xD;
        and treatment. The immune response to meningococcal polysaccharide vaccine is weak in infants&#xD;
        under 2 years of age, and only a transient immune response is produced. Numerous experiments&#xD;
        have shown that the immunogenicity of polysaccharides is enhanced by binding to protein&#xD;
        carriers, and a significant booster effect is produced. Meningococcal polysaccharide&#xD;
        conjugate vaccine induces a good immune response in infants and children under 2 years of age&#xD;
        and produces immune memory, which enhances the immune effect of the vaccine and can eliminate&#xD;
        the carrier state of infected patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Geometric mean titers (GMT) of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization</measure>
      <time_frame>30 days after immunization</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Positive conversion rates of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization</measure>
      <time_frame>30 days after immunization</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of adverse reactions within 30 minutes after immunization in all subjects</measure>
      <time_frame>Within 30 minutes after immunization</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of adverse reactions/events within 7 days of immunization for all subjects</measure>
      <time_frame>Within 7 days after immunization</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of adverse reactions/events within 30 days of exemption for all subjects</measure>
      <time_frame>Within 30 days of exemption</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Meningococcal positivity for groups A, C, Y, and W135 for all subjects 30 days after immunization</measure>
      <time_frame>30 days after immunization</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric mean growth multiplier (GMI) for all subjects 30 days after immunization</measure>
      <time_frame>30 days after immunization</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antibody titers ≥1:128 ratio for all subjects 30 days after immunization</measure>
      <time_frame>30 days after immunization</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Meningococcal antibody positivity for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects</measure>
      <time_frame>90 and 180 days of exemption</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GMT for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects</measure>
      <time_frame>90 and 180 days of exemption</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GMI for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects</measure>
      <time_frame>90 and 180 days of exemption</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antibody titers ≥1:128 ratio for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects</measure>
      <time_frame>90 and 180 days of exemption</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of serious adverse events (SAEs) within 180 days of exemption in all subjects</measure>
      <time_frame>Within 180 days of exemption</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All subjects were stratified into susceptible (&lt;1:8) and non-susceptible (≥1:8) populations according to the 1:8 pre-immune antibody titer threshold</measure>
      <time_frame>30 days after immunization</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Epidemic Meningitis</condition>
    <arm_group>
      <arm_group_label>ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intramuscular injection, 0.5ml</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ACYW135 Group Meningococcal Polysaccharide Vaccine (MSPV4)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subcutaneous injection, 0.5ml</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>MCV4</intervention_name>
      <description>1 dose of MCV4 on Day 0</description>
      <arm_group_label>ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>MSPV4</intervention_name>
      <description>1 dose of MSPV4 on Day 0</description>
      <arm_group_label>ACYW135 Group Meningococcal Polysaccharide Vaccine (MSPV4)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children aged 4~6 years old&#xD;
  &#xD;
            -  Complete at least two doses of basic immunization with polysaccharide influenza&#xD;
               vaccine according to the immunization program&#xD;
  &#xD;
            -  The legal guardian or delegate has given informed consent, voluntarily signed the&#xD;
               informed consent form, and is able to comply with the requirements of the clinical&#xD;
               study protocol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Fever before inoculation, axillary temperature &gt;37.0℃&#xD;
  &#xD;
            -  Previous history of immunization with meningococcal polysaccharide conjugate vaccine&#xD;
  &#xD;
            -  Congenital malformations or developmental disorders, genetic defects, severe&#xD;
               malnutrition, etc.&#xD;
  &#xD;
            -  History of epilepsy, convulsions or seizures or a history of psychiatric illness or&#xD;
               family history&#xD;
  &#xD;
            -  Volunteers with current meningitis or a history of meningitis&#xD;
  &#xD;
            -  Volunteers treated with immunosuppressive therapy, cytotoxic therapy, glucocorticoids&#xD;
               (excluding topical treatment, surface treatment for acute uncomplicated dermatitis,&#xD;
               spray treatment for allergic rhinitis) within the past 6 months (&lt;6 months)&#xD;
  &#xD;
            -  Received blood/plasma products or immunoglobulins within 60 days (&lt;60 days) prior to&#xD;
               study vaccination or planned to receive blood/plasma products or immunoglobulins&#xD;
               throughout the study period&#xD;
  &#xD;
            -  Suffering from serious chronic diseases or conditions that are in a progressive stage&#xD;
               and cannot be controlled smoothly, such as thyroid disease&#xD;
  &#xD;
            -  Volunteers with known or suspected diseases that are judged by the investigator to&#xD;
               affect vaccination such as severe respiratory disease, acute infection or active&#xD;
               chronic disease, severe cardiovascular disease, severe liver or kidney disease,&#xD;
               malignancy, severe infectious or allergic skin disease&#xD;
  &#xD;
            -  History of serious adverse reactions associated with the vaccine and/or history of&#xD;
               severe allergic reactions (e.g., systemic allergic reactions) to any component of the&#xD;
               investigational vaccine&#xD;
  &#xD;
            -  Immunocompromised individuals with known or suspected immunodeficiency as determined&#xD;
               by medical history and/or physical examination (e.g., malignancy, HIV, etc.)&#xD;
  &#xD;
            -  Bleeding constitution or condition associated with prolonged bleeding, investigators&#xD;
               consider intramuscular injection to be contraindicated&#xD;
  &#xD;
            -  Live attenuated vaccine given within 14 days, other vaccines given within 7 days&#xD;
  &#xD;
            -  Participation in other studies involving interventions within 28 days (&lt;28 days) prior&#xD;
               to study entry and/or during study participation&#xD;
  &#xD;
            -  Other conditions judged by the investigator to be inappropriate for participation in&#xD;
               this clinical trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Shupeng Zhang</last_name>
      <phone>022-58213600-6051</phone>
      <email>shupeng.zhang@cansinotech.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Weijun Hu</last_name>
      <phone>029-82221350</phone>
      <email>huwj0828@163.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ACYW135</keyword>
    <keyword>CRM197</keyword>
    <keyword>Immunogenicity</keyword>
    <keyword>Safety</keyword>
    <keyword>4~6 yearsof age</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Meningitis, Meningococcal</mesh_term>
      <mesh_term>Meningitis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011200
  org study id: CTP-MCVF-002
  nct id: NCT06011200
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The scientific name of meningococcus is Neisseria meningitidis (Nm), the causative agent of
        epidemic meningococcal meningitis (rheumatoid encephalitis), which colonizes the mucous
        membranes of the human nasopharynx or causes local infection and can cross the mucosal
        barrier to cause invasive bacteremia or epidemic meningococcal meningitis, meningococcus can
        often cause serious disease epidemics worldwide, the main clinical features of its infection
        are fever, rash and meningitis, the most common clinical manifestation is acute bacterial
        meningitis.
  The preventive measures for influenza are based on strengthening personal protection,
        vaccination, strengthening surveillance, early detection of patients, and active isolation
        and treatment. The immune response to meningococcal polysaccharide vaccine is weak in infants
        under 2 years of age, and only a transient immune response is produced. Numerous experiments
        have shown that the immunogenicity of polysaccharides is enhanced by binding to protein
        carriers, and a significant booster effect is produced. Meningococcal polysaccharide
        conjugate vaccine induces a good immune response in infants and children under 2 years of age
        and produces immune memory, which enhances the immune effect of the vaccine and can eliminate
        the carrier state of infected patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Geometric mean titers (GMT) of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization
  time frame: 30 days after immunization
  measure: Positive conversion rates of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization
  time frame: 30 days after immunization
  measure: Incidence of adverse reactions within 30 minutes after immunization in all subjects
  time frame: Within 30 minutes after immunization
  measure: Incidence of adverse reactions/events within 7 days of immunization for all subjects
  time frame: Within 7 days after immunization
  measure: Incidence of adverse reactions/events within 30 days of exemption for all subjects
  time frame: Within 30 days of exemption
  measure: Meningococcal positivity for groups A, C, Y, and W135 for all subjects 30 days after immunization
  time frame: 30 days after immunization
  measure: Geometric mean growth multiplier (GMI) for all subjects 30 days after immunization
  time frame: 30 days after immunization
  measure: Antibody titers ≥1:128 ratio for all subjects 30 days after immunization
  time frame: 30 days after immunization
  measure: Meningococcal antibody positivity for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
  time frame: 90 and 180 days of exemption
  measure: GMT for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
  time frame: 90 and 180 days of exemption
  measure: GMI for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
  time frame: 90 and 180 days of exemption
  measure: Antibody titers ≥1:128 ratio for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects
  time frame: 90 and 180 days of exemption
  measure: Incidence of serious adverse events (SAEs) within 180 days of exemption in all subjects
  time frame: Within 180 days of exemption
  measure: All subjects were stratified into susceptible (<1:8) and non-susceptible (≥1:8) populations according to the 1:8 pre-immune antibody titer threshold
  time frame: 30 days after immunization
  arm group label: ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)
  arm group type: Experimental
  description: Intramuscular injection, 0.5ml
  arm group label: ACYW135 Group Meningococcal Polysaccharide Vaccine (MSPV4)
  arm group type: Active Comparator
  description: Subcutaneous injection, 0.5ml
  intervention type: Biological
  intervention name: MCV4
  description: 1 dose of MCV4 on Day 0
  arm group label: ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)
  intervention type: Biological
  intervention name: MSPV4
  description: 1 dose of MSPV4 on Day 0
  arm group label: ACYW135 Group Meningococcal Polysaccharide Vaccine (MSPV4)
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 6 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shupeng Zhang
  phone: 022-58213600-6051
  email: shupeng.zhang@cansinotech.com
  last name: Weijun Hu
  phone: 029-82221350
  email: huwj0828@163.com
  responsible party type: Sponsor
  mesh term: Meningitis, Meningococcal
  mesh term: Meningitis