<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/NCT01661725</url>
  </required_header>
  <id_info>
    <org_study_id>Hualanbio-Meningococcal CT 001</org_study_id>
    <secondary_id>Hualanbio-phase I CT</secondary_id>
    <nct_id>NCT01661725</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001</brief_title>
  <official_title>Phase I 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 against Group ACYW135 Meningococcal&#xD;
      Polysaccharide Vaccine of Hualan administered on subjects 2 years of 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 I clinical trial of Group ACYW135&#xD;
      Meningococcal Polysaccharide Vaccine. The safety end points were the presence of any&#xD;
      systemic, local and adverse reaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2006</start_date>
  <completion_date type="Actual">May 2006</completion_date>
  <primary_completion_date type="Actual">April 2006</primary_completion_date>
  <phase>Phase 1</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>All systemic and local adverse reactions and related adverse events on day 28 after the vaccination</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</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>0.5ml/ vial</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Group ACYW135 Meningococcal Polysaccharide Vaccine</intervention_name>
    <description>60 subjects were divided into three groups (20 subjects each group), adult (16~30 years of age), early youth (7~15 years of age) and children (2~6 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 Meningococcal 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/NCT01661725
org study id: Hualanbio-Meningococcal CT 001
secondary id: Hualanbio-phase I CT
nct id: NCT01661725
lead sponsor: 
has dmc: Yes
The clinical trial was designed to evaluate the safety 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 I clinical trial of Group ACYW135
      Meningococcal Polysaccharide Vaccine. The safety end points were the presence of any
      systemic, local and adverse reaction.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Safety
time frame: Day 28 after vaccination
description: All systemic and local adverse reactions and related adverse events on day 28 after the vaccination
arm group label: Group ACYW135 Meningococcal Polysaccharide Vaccine
arm group type: Experimental
description: 0.5ml/ vial
intervention type: Biological
intervention name: Group ACYW135 Meningococcal Polysaccharide Vaccine
description: 60 subjects were divided into three groups (20 subjects each group), adult (16~30 years of age), early youth (7~15 years of age) and children (2~6 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