<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/NCT02219061</url>
  </required_header>
  <id_info>
    <org_study_id>GZCDC001</org_study_id>
    <nct_id>NCT02219061</nct_id>
  </id_info>
  <brief_title>Early Waning of Maternal Measles and Meningitis C Antibodies</brief_title>
  <acronym>EWMM</acronym>
  <official_title>Observation Study on Early Waning of Maternal Measles and Meningitis C Antibodies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Center for Disease Control and Prevention</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Maternal antibodies (measles and meningitis C) may wane in the first six months after birth.&#xD;
&#xD;
        -  Geometric mean titers(GMTs) of measles and meningitis C.&#xD;
&#xD;
        -  Follow-up on 0 month, 3rd month,5th month and 7th month after birth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Measles and meningitis C are hot topics in China in recent years. Although China had set the&#xD;
      goal of measles elimination, many measles cases were found to be those aged &lt; 8 months and&#xD;
      meningitis C is becoming public health issue since meningitis group A has been controlled at&#xD;
      a very low level and little is known on C group. So the investigators designed the&#xD;
      observation study on the two antibodies.&#xD;
&#xD;
      Maternal antibodies are supposed to wane after birth. Serums of the placenta(0 month),&#xD;
      children of 3 months, 5 months and 7 months old will be collected and the geometric mean&#xD;
      titers (GMTs) of measles and meningitis C will be confirmed by using the ELISA test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Geometric Mean Titer</measure>
    <time_frame>Up to six months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Measles</condition>
  <arm_group>
    <arm_group_label>GMT</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Children's Serum will be collected for measles and meningitis C antibodies test by ELISA&#xD;
      method.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Infants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy infants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with poor score.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>7 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou CDC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chuanxi Fu, PhD</last_name>
    <phone>+86 20 36055887</phone>
    <email>fuchuanxi@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guangzhou Center for Disease Control and Prevention</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510440</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chuanxi</last_name>
      <phone>+86 20 36055887</phone>
    </contact>
    <contact_backup>
      <last_name>Ming</last_name>
      <email>48280698@qq.com</email>
    </contact_backup>
    <investigator>
      <last_name>Long Lu, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Measles</keyword>
  <keyword>Meningitis C</keyword>
  <keyword>waning</keyword>
  <keyword>Geometric Mean Titer</keyword>
  <keyword>China</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Measles</mesh_term>
    <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/NCT02219061
org study id: GZCDC001
nct id: NCT02219061
lead sponsor: 
has dmc: Yes
Maternal antibodies (measles and meningitis C) may wane in the first six months after birth.

        -  Geometric mean titers(GMTs) of measles and meningitis C.

        -  Follow-up on 0 month, 3rd month,5th month and 7th month after birth.
Measles and meningitis C are hot topics in China in recent years. Although China had set the
      goal of measles elimination, many measles cases were found to be those aged < 8 months and
      meningitis C is becoming public health issue since meningitis group A has been controlled at
      a very low level and little is known on C group. So the investigators designed the
      observation study on the two antibodies.

      Maternal antibodies are supposed to wane after birth. Serums of the placenta(0 month),
      children of 3 months, 5 months and 7 months old will be collected and the geometric mean
      titers (GMTs) of measles and meningitis C will be confirmed by using the ELISA test.
time perspective: Prospective
measure: Geometric Mean Titer
time frame: Up to six months
arm group label: GMT
Children's Serum will be collected for measles and meningitis C antibodies test by ELISA
      method.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 7 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Ming Wang
role: Principal Investigator
affiliation: Guangzhou CDC
last name: Chuanxi Fu, PhD
phone: +86 20 36055887
email: fuchuanxi@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Measles
mesh term: Meningitis