<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/NCT01661738</url>
  </required_header>
  <id_info>
    <org_study_id>Hualanbio-Meningococcal CT 002</org_study_id>
    <secondary_id>Hualanbio-phase II CT</secondary_id>
    <nct_id>NCT01661738</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 002</brief_title>
  <official_title>Phase II Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hualan Biological Engineering, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hualan Biological Engineering, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical trial was designed to evaluate the safety and immunogenicity against Group&#xD;
      ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of&#xD;
      age and older.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval&#xD;
      Letter No.: 2006L01017), Hualan conducted phase II clinical trial of Group ACYW135&#xD;
      Meningococcal Polysaccharide Vaccine to evaluate the safety and immunogenicity of the&#xD;
      experimental vaccine.&#xD;
&#xD;
      The safety end points were the presence of any systemic, local and adverse reaction.&#xD;
      Evaluation indicators of immunogenicity were bacteriocin levels of groups A, C, Y and W135&#xD;
      respectively in the serum after the whole vaccination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2006</start_date>
  <completion_date type="Actual">June 2006</completion_date>
  <primary_completion_date type="Actual">May 2006</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>Day 28 after vaccination</time_frame>
    <description>Systemic and local adverse reactions after the vaccination; adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>The 4th week after immunization</time_frame>
    <description>4-fold (seroconversion) and 8-fold increase of bactericidin; GMT and bactericidin increase after immunization</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Meningitis</condition>
  <arm_group>
    <arm_group_label>Group ACYW135 Meningococcal Polysaccharide Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 ml/ vial</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Group ACYW135 Meningococcal Polysaccharide Vaccine</intervention_name>
    <description>360 subjects were divided into three groups (120 subjects in each group), children (2~6 years of age), early youth (7~15 years of age) and adult (16~30 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime</description>
    <arm_group_label>Group ACYW135 Meningococcal Polysaccharide Vaccine</arm_group_label>
    <other_name>Hualan Bio</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy permanent residence 2 years of age and older, the subjects (or their&#xD;
             guardians) are able to understand and sign the informed consent;&#xD;
&#xD;
          -  Healthy male or female by oral history, physical examination and clinical judgment and&#xD;
             who complies with vaccination of this product;&#xD;
&#xD;
          -  Be able to comply with the requirements of clinical trial protocol and immunogenicity&#xD;
             examination;&#xD;
&#xD;
          -  Have no history of vaccination within the past 3 months and vaccination with other&#xD;
             products within the last 2 weeks;&#xD;
&#xD;
          -  Axillary temperature ≤37.0℃.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic&#xD;
             disease or diabetes with complication, chronic obstructive pulmonary disease need&#xD;
             oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive&#xD;
             heart-failure, etc.;&#xD;
&#xD;
          -  Allergic to vaccines or drugs (history of allergy to any vaccine in the past);&#xD;
&#xD;
          -  History of neurologic symptom or signs;&#xD;
&#xD;
          -  Known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive&#xD;
             immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product&#xD;
             or plasma extract (except the gastrointestinal tract) within the past 3 months, HIV&#xD;
             infection or related disease, etc.;&#xD;
&#xD;
          -  History of meningitis infection or vaccination of meningococcal vaccine within the&#xD;
             past 3 months;&#xD;
&#xD;
          -  History of receiving other vaccines or immunoglobulin injection or any research drugs;&#xD;
&#xD;
          -  Any acute disease needing application of antibiotics or anti-virus treatment in the&#xD;
             whole body within the past 1 week;&#xD;
&#xD;
          -  History of fever within the past 3 days (axillary temperature ≥38.0℃);&#xD;
&#xD;
          -  Participating in another clinical trial;&#xD;
&#xD;
          -  History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family&#xD;
             disease;&#xD;
&#xD;
          -  Thrombopenia or other coagulopathy that may cause contraindication to intramuscular&#xD;
             injection;&#xD;
&#xD;
          -  Acute chronic disease (such as Down syndrome, diabetes, sickle cell anemia or&#xD;
             neurologic disease, Guillain-Barre Syndrome);&#xD;
&#xD;
          -  Known or suspected diseases, including: respiratory system disease, acute infection or&#xD;
             active stage of chronic disease, SBAV infection of children or mothers, cardiovascular&#xD;
             disease, acute hypertension, cancer treatment, skin disease, etc.;&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any condition that, in the judgment of investigator, may affect trial assessment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fubao Ma, Bachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Immunization Program Institute of Jiangsu Provincial Center for Disease Control and Prevention</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 6, 2012</last_update_submitted>
  <last_update_submitted_qc>August 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Group ACYW135 Meninigococcal Polysaccharide Vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningitis</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/NCT01661738
org study id: Hualanbio-Meningococcal CT 002
secondary id: Hualanbio-phase II CT
nct id: NCT01661738
lead sponsor: 
has dmc: Yes
The clinical trial was designed to evaluate the safety and immunogenicity against Group
      ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of
      age and older.
Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval
      Letter No.: 2006L01017), Hualan conducted phase II clinical trial of Group ACYW135
      Meningococcal Polysaccharide Vaccine to evaluate the safety and immunogenicity of the
      experimental vaccine.

      The safety end points were the presence of any systemic, local and adverse reaction.
      Evaluation indicators of immunogenicity were bacteriocin levels of groups A, C, Y and W135
      respectively in the serum after the whole vaccination.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Safety
time frame: Day 28 after vaccination
description: Systemic and local adverse reactions after the vaccination; adverse events
measure: Immunogenicity
time frame: The 4th week after immunization
description: 4-fold (seroconversion) and 8-fold increase of bactericidin; GMT and bactericidin increase after immunization
arm group label: Group ACYW135 Meningococcal Polysaccharide Vaccine
arm group type: Experimental
description: 0.5 ml/ vial
intervention type: Biological
intervention name: Group ACYW135 Meningococcal Polysaccharide Vaccine
description: 360 subjects were divided into three groups (120 subjects in each group), children (2~6 years of age), early youth (7~15 years of age) and adult (16~30 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
arm group label: Group ACYW135 Meningococcal Polysaccharide Vaccine
other name: Hualan Bio
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fubao Ma, Bachelor
role: Principal Investigator
affiliation: Immunization Program Institute of Jiangsu Provincial Center for Disease Control and Prevention
responsible party type: Sponsor
mesh term: Meningitis