<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/NCT04450498</url>
  </required_header>
  <id_info>
    <org_study_id>MPV ACYW-004</org_study_id>
    <nct_id>NCT04450498</nct_id>
  </id_info>
  <brief_title>A Study to Demonstrate Non-inferior Immunogenicity of Yuxi Walvax MPV ACYW® Vaccine in Healthy Subjects Aged 2-10 Years</brief_title>
  <official_title>A Phase IV Randomized, Observer-blind, Controlled Study to Demonstrate Non-inferior Immunogenicity of Yuxi Walvax MPV ACYW® Vaccine as Compared to Sanofi Pasteur Menactra® Vaccine in Healthy Subjects Aged 2-10 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Walvax Biotechnology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Walvax Biotechnology Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase IV, single-center, observer-blind, randomized, controlled vaccine trial in 2&#xD;
      to 10 years old healthy subjects. Each participant will receive a single intramuscular&#xD;
      injection of one of the two vaccines either MPV ACYW® vaccine or Menactra ® vaccine according&#xD;
      to the vaccine group assignment and will be followed up for one month for immunogenicity&#xD;
      evaluation and for 6 months for safety evaluation.&#xD;
&#xD;
      Statistical Hypothesis:&#xD;
&#xD;
      H0: Seroconversion rate of test group is inferior to that of control group HA: Seroconversion&#xD;
      rate of test group is non-inferior to that of control group Sample size calculation: the&#xD;
      sample size was calculated based on non-inferiority test with alpha level of 0.025 and 80%&#xD;
      power, assuming seroconversion rate in control group was 95% with non-inferiority margin at&#xD;
      10%. The sample size required for the study is 124 per arm. After adjusting for 5% drop-out,&#xD;
      the final sample size required is 130 per arm.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 23, 2020</start_date>
  <completion_date type="Actual">July 30, 2021</completion_date>
  <primary_completion_date type="Actual">July 30, 2021</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>At Day 0, eligible subjects will be randomized in a 1:1 ratio into either Walvax MPV ACYW® vaccine group (130 subjects) or Sanofi Pasteur Menactra ® vaccine group (130 subjects). A randomization list containing subject numbers and vaccine group assignments will be provided to the investigator. Each participant will receive a single intramuscular injection of one of the two vaccines either MPV ACYW® vaccine or Menactra ® vaccine according to the vaccine group assignment and will be followed up for one month for immunogenicity evaluation and for 6 months for safety evaluation.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The study will be carried out in an observer blind fashion until database is locked with data collected until Day 30 (Visit 3) after vaccination. The clinical study material, i.e. vaccine packs, will be packaged and encoded according to the randomization list (see Appendix B for example of vaccine labels). At study site, the investigator will assign unblinded designated person(s) responsible for vaccine handling, administration (&quot;Vaccinator&quot;) and accountability to ensure that blinding is protected throughout the study procedures and that no other site personnel involved in the conduct of the study has access to the information. After assessment of eligibility of a new subject, the investigator will complete a form that the subject will take to the &quot;vaccinator&quot;. The &quot;vaccinator&quot; will administer the vaccine according to the randomization list to the subject without informing neither the subject nor the investigator of the randomization group, i.e. the nature of the vaccine.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Antibody response at Day 30 post-vaccination</measure>
    <time_frame>Day 30 post-vaccination</time_frame>
    <description>Percentage of subjects with rSBA (Serum Bactericidal Activity using baby rabbit complement) titer ≥1:128 to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups 30 days after immunization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentages of subjects with post-immunization local and systemic reactions within 7 days following vaccination in both vaccine groups</measure>
    <time_frame>Day 7 post-vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of subjects with reported Adverse Events within 30 days following vaccination in both vaccine groups</measure>
    <time_frame>Day 30 post-vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of subjects with reported SAEs within 6 months following vaccination in both vaccine groups</measure>
    <time_frame>Day 30 to Day 180 post-vaccination (end of study visit)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rSBA Geometric mean antibody titers to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups</measure>
    <time_frame>Day 30 post-vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with rSBA titer ≥1:8 to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups 30 days after immunization</measure>
    <time_frame>Day 30 post-vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rates as defined by proportion of subjects with ≥ 4-fold increase 30 days after immunization with respect to baseline of rSBA antibodies to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups 30 days after immunization</measure>
    <time_frame>Day 30 post-vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rates as defined by proportion of subjects with ≥ 2-fold increase 30 days after immunization with respect to baseline of rSBA antibodies to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups</measure>
    <time_frame>Day 30 post-vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Neisseria Meningitides Meningitis</condition>
  <arm_group>
    <arm_group_label>Walvax MPV ACYW® vaccine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sanofi Pasteur Menactra® vaccine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Yuxi Walvax MPV ACYW® vaccine</intervention_name>
    <description>Walvax MPV ACYW vaccine is a sterile formulation of polysaccharide A,C,Y,W-135. One dose of 0.5 mL contains 50 µg of each A,C,Y,W-135 purified polysaccharide. The vaccine is presented in two vials: one containing the lyophilized cake of A,C,Y,W purified polysaccharides and the other the sterile water for injection as diluent. After reconstitution the one dose of 0.5 mL is ready for subcutaneous injection. The antigen content is similar to other internationally marketed polysaccharide vaccines that have been in use for decades as Menomune® Sanofi and Mencevax® Pfizer , all containing 50 µg of each A,C,Y,W purified polysaccharide that as one dose schedule are recommended for use in subjects &gt; 2 years of age and have shown to be safe and immunogenic.</description>
    <arm_group_label>Walvax MPV ACYW® vaccine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Sanofi Pasteur Menactra® vaccine</intervention_name>
    <description>The vaccine presentation is a full liquid formulation in a single dose of 0.5 mL with the following composition: Meningococcal group A polysaccharide 4 µg; Meningococcal group C polysaccharide 4 µg; Meningococcal group Y polysaccharide 4 µg; Meningococcal group W polysaccharide 4 µg; Diphtheria toxoid protein total 48 µg; Sodium phosphate 0.7 mg; Sodium chloride 4.35 mg.</description>
    <arm_group_label>Sanofi Pasteur Menactra® vaccine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 2 to 10 years of age (both included)&#xD;
&#xD;
          -  Written informed consent obtained from the mother, father, or guardian of the child.&#xD;
&#xD;
          -  Free of obvious health problems and be fully vaccinated according local EPI schedule&#xD;
             as established by medical history including physical examination and clinical judgment&#xD;
             of the investigator.&#xD;
&#xD;
          -  Mother, father, or guardian capable and willing to bring their child or to receive&#xD;
             home visits for their child for all follow-up visits.&#xD;
&#xD;
          -  Residence in the study area during the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vaccination against group A,C,Y,W Neisseria meningitidis in the previous 3 months&#xD;
&#xD;
          -  History of allergic disease or known hypersensitivity to any component of the two&#xD;
             study vaccines.&#xD;
&#xD;
          -  History of serious adverse reactions following administration of vaccines included in&#xD;
             the local program of immunization.&#xD;
&#xD;
          -  Administration of any other vaccine within 30 days prior to administration of study&#xD;
             vaccines or planned vaccination during the first four weeks after the study&#xD;
             vaccination.&#xD;
&#xD;
          -  Use of any investigational or nonregistered product within 60 days prior to the&#xD;
             administration of study vaccines.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products or planned administration&#xD;
             during the study participation period.&#xD;
&#xD;
          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other&#xD;
             immune-modifying agents since birth (including systemic or inhaled corticosteroids,&#xD;
             this means prednisone, or equivalent, ≥0.5 mg/kg/day; topical steroids are allowed).&#xD;
&#xD;
          -  A family history of congenital or hereditary immunodeficiency.&#xD;
&#xD;
          -  History of meningitis or seizures, or any neurological disorder, convulsions, or&#xD;
             active tuberculosis.&#xD;
&#xD;
          -  Major congenital defects or serious chronic illness, including malnutrition (i.e.,&#xD;
             weight less than or equal to 3 standard deviations below the mean for 2-5 years old)&#xD;
             and immunodeficiency disorder (as per investigator's judgment)&#xD;
&#xD;
          -  Acute disease at the time of enrollment (acute disease being defined as the presence&#xD;
             of a moderate or severe illness with or without fever) resulting in a temporary&#xD;
             exclusion.&#xD;
&#xD;
          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal&#xD;
             functional abnormality, as determined by medical history, physical examination, or&#xD;
             laboratory tests, which in the opinion of the investigator might interfere with the&#xD;
             well-being of the subject study objectives.&#xD;
&#xD;
          -  Any condition or criterion that in the opinion of the investigator might compromise&#xD;
             the well-being of the subject or the compliance with study procedures or interfere&#xD;
             with the outcome of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samba O Sow, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director General</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre pour le Développement des Vaccins du Mali</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mali</country>
  </location_countries>
  <results_reference>
    <citation>Sow SO, Tapia MD, Haidara FC, Diallo F, Traore Y, Traore A, Kodio M, Borrow R, Townsend-Payne K, Yuan L, Yang S, Shi L, Chen J, Fang G, Lin J, Hu R, Viviani S, Huang Z. Safety and immunogenicity of quadrivalent meningococcal polysaccharide vaccine (MPV ACYW135) compared with quadrivalent meningococcal conjugate vaccine (Menactra(R)) in Malian children. Hum Vaccin Immunother. 2023 Aug 1;19(2):2230829. doi: 10.1080/21645515.2023.2230829. Epub 2023 Jul 4.</citation>
    <PMID>37401618</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neisseria Meningitidis</keyword>
  <keyword>Non-inferior immunogenicity</keyword>
  <keyword>Safety</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04450498
org study id: MPV ACYW-004
nct id: NCT04450498
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a phase IV, single-center, observer-blind, randomized, controlled vaccine trial in 2
      to 10 years old healthy subjects. Each participant will receive a single intramuscular
      injection of one of the two vaccines either MPV ACYW® vaccine or Menactra ® vaccine according
      to the vaccine group assignment and will be followed up for one month for immunogenicity
      evaluation and for 6 months for safety evaluation.

      Statistical Hypothesis:

      H0: Seroconversion rate of test group is inferior to that of control group HA: Seroconversion
      rate of test group is non-inferior to that of control group Sample size calculation: the
      sample size was calculated based on non-inferiority test with alpha level of 0.025 and 80%
      power, assuming seroconversion rate in control group was 95% with non-inferiority margin at
      10%. The sample size required for the study is 124 per arm. After adjusting for 5% drop-out,
      the final sample size required is 130 per arm.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: At Day 0, eligible subjects will be randomized in a 1:1 ratio into either Walvax MPV ACYW® vaccine group (130 subjects) or Sanofi Pasteur Menactra ® vaccine group (130 subjects). A randomization list containing subject numbers and vaccine group assignments will be provided to the investigator. Each participant will receive a single intramuscular injection of one of the two vaccines either MPV ACYW® vaccine or Menactra ® vaccine according to the vaccine group assignment and will be followed up for one month for immunogenicity evaluation and for 6 months for safety evaluation.
primary purpose: Prevention
masking: Single (Investigator)
masking description: The study will be carried out in an observer blind fashion until database is locked with data collected until Day 30 (Visit 3) after vaccination. The clinical study material, i.e. vaccine packs, will be packaged and encoded according to the randomization list (see Appendix B for example of vaccine labels). At study site, the investigator will assign unblinded designated person(s) responsible for vaccine handling, administration ("Vaccinator") and accountability to ensure that blinding is protected throughout the study procedures and that no other site personnel involved in the conduct of the study has access to the information. After assessment of eligibility of a new subject, the investigator will complete a form that the subject will take to the "vaccinator". The "vaccinator" will administer the vaccine according to the randomization list to the subject without informing neither the subject nor the investigator of the randomization group, i.e. the nature of the vaccine.
measure: Antibody response at Day 30 post-vaccination
time frame: Day 30 post-vaccination
description: Percentage of subjects with rSBA (Serum Bactericidal Activity using baby rabbit complement) titer ≥1:128 to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups 30 days after immunization
measure: Percentages of subjects with post-immunization local and systemic reactions within 7 days following vaccination in both vaccine groups
time frame: Day 7 post-vaccination
measure: Percentages of subjects with reported Adverse Events within 30 days following vaccination in both vaccine groups
time frame: Day 30 post-vaccination
measure: Percentages of subjects with reported SAEs within 6 months following vaccination in both vaccine groups
time frame: Day 30 to Day 180 post-vaccination (end of study visit)
measure: rSBA Geometric mean antibody titers to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups
time frame: Day 30 post-vaccination
measure: Percentage of subjects with rSBA titer ≥1:8 to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups 30 days after immunization
time frame: Day 30 post-vaccination
measure: Seroconversion rates as defined by proportion of subjects with ≥ 4-fold increase 30 days after immunization with respect to baseline of rSBA antibodies to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups 30 days after immunization
time frame: Day 30 post-vaccination
measure: Seroconversion rates as defined by proportion of subjects with ≥ 2-fold increase 30 days after immunization with respect to baseline of rSBA antibodies to A,C,Y,W meningococcal capsular polysaccharide in both vaccine groups
time frame: Day 30 post-vaccination
arm group label: Walvax MPV ACYW® vaccine group
arm group type: Experimental
arm group label: Sanofi Pasteur Menactra® vaccine group
arm group type: Active Comparator
intervention type: Biological
intervention name: Yuxi Walvax MPV ACYW® vaccine
description: Walvax MPV ACYW vaccine is a sterile formulation of polysaccharide A,C,Y,W-135. One dose of 0.5 mL contains 50 µg of each A,C,Y,W-135 purified polysaccharide. The vaccine is presented in two vials: one containing the lyophilized cake of A,C,Y,W purified polysaccharides and the other the sterile water for injection as diluent. After reconstitution the one dose of 0.5 mL is ready for subcutaneous injection. The antigen content is similar to other internationally marketed polysaccharide vaccines that have been in use for decades as Menomune® Sanofi and Mencevax® Pfizer , all containing 50 µg of each A,C,Y,W purified polysaccharide that as one dose schedule are recommended for use in subjects > 2 years of age and have shown to be safe and immunogenic.
arm group label: Walvax MPV ACYW® vaccine group
intervention type: Biological
intervention name: Sanofi Pasteur Menactra® vaccine
description: The vaccine presentation is a full liquid formulation in a single dose of 0.5 mL with the following composition: Meningococcal group A polysaccharide 4 µg; Meningococcal group C polysaccharide 4 µg; Meningococcal group Y polysaccharide 4 µg; Meningococcal group W polysaccharide 4 µg; Diphtheria toxoid protein total 48 µg; Sodium phosphate 0.7 mg; Sodium chloride 4.35 mg.
arm group label: Sanofi Pasteur Menactra® vaccine group
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Samba O Sow, MD, MSc
role: Principal Investigator
affiliation: Director General
facility: 
country: Mali
citation: Sow SO, Tapia MD, Haidara FC, Diallo F, Traore Y, Traore A, Kodio M, Borrow R, Townsend-Payne K, Yuan L, Yang S, Shi L, Chen J, Fang G, Lin J, Hu R, Viviani S, Huang Z. Safety and immunogenicity of quadrivalent meningococcal polysaccharide vaccine (MPV ACYW135) compared with quadrivalent meningococcal conjugate vaccine (Menactra(R)) in Malian children. Hum Vaccin Immunother. 2023 Aug 1;19(2):2230829. doi: 10.1080/21645515.2023.2230829. Epub 2023 Jul 4.
PMID: 37401618
responsible party type: Sponsor
mesh term: Meningitis, Meningococcal
mesh term: Meningitis
mesh term: Vaccines
sharing ipd: No