<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/NCT01705379</url>
  </required_header>
  <id_info>
    <org_study_id>V59_45OB</org_study_id>
    <nct_id>NCT01705379</nct_id>
  </id_info>
  <brief_title>Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older</brief_title>
  <official_title>A Multicenter, Single Arm, Post Marketing Surveillance Study to Monitor the Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects 2 Years of Age and Older in the Philippines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Vaccines</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure&#xD;
      requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety&#xD;
      evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving&#xD;
      MenACWY-CRM vaccination according to routine clinical practice and prescribing information.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Anticipated">April 2016</completion_date>
  <primary_completion_date type="Anticipated">April 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>All adverse events</measure>
    <time_frame>Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>All serious adverse events</measure>
    <time_frame>Day 29</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Meningococcal Disease</condition>
  <arm_group>
    <arm_group_label>MenACWY-CRM</arm_group_label>
    <description>2 years of age and older</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Novartis Meningococcal ACWY Conjugate Vaccine</intervention_name>
    <description>Immunization</description>
    <arm_group_label>MenACWY-CRM</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy male and female subjects 2 years of age and older&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Individuals eligible for enrolment in this study are those:&#xD;
&#xD;
          1. who are of any gender, from the age of 2 and older, and to whom/whose parents or&#xD;
             legally acceptable representatives the nature of the study has been described and the&#xD;
             subject/subject's parent/legally acceptable representative has provided written&#xD;
             informed consent.&#xD;
&#xD;
          2. who the investigator believes that the subject and/or his or her parent/legal&#xD;
             representative can and will comply with the requirements of the protocol.&#xD;
&#xD;
          3. who are in good health as determined by clinical judgment of the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Individuals not eligible to be enrolled in the study are those:&#xD;
&#xD;
          1. who are unwilling or unable to give written informed consent or assent to participate&#xD;
             in the study.&#xD;
&#xD;
          2. who are perceived to be unreliable or unavailable for the duration of the study&#xD;
             period.&#xD;
&#xD;
          3. who have previously been immunized with a meningococcal vaccine or vaccine containing&#xD;
             meningococcal antigen(s) (licensed or investigational).&#xD;
&#xD;
          4. who have received any investigational or non-registered product (drug or vaccine)&#xD;
             within 30 days prior to enrolment or who expect to receive an investigational drug or&#xD;
             vaccine prior to the completion of the study.&#xD;
&#xD;
          5. who have received or who are planning to receive any vaccines (other than routine&#xD;
             childhood vaccines) within 30 days before and after administration of study vaccine.&#xD;
&#xD;
             (Exception: Influenza vaccine may be administered up to 15 days prior to study&#xD;
             vaccination and at least 15 days after study vaccination)&#xD;
&#xD;
          6. who have behavioral or cognitive impairment or psychiatric disease that, in the&#xD;
             opinion of the investigator, may interfere with the subject's ability to participate&#xD;
             in the study.&#xD;
&#xD;
          7. who are pregnant or breast feeding (female subjects of appropriate age) or who plan to&#xD;
             become pregnant during the course of the study.&#xD;
&#xD;
          8. who have any serious acute, chronic or progressive disease (e.g., any history of&#xD;
             neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or&#xD;
             AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe&#xD;
             malnutrition), who have epilepsy or any progressive neurological disease or history of&#xD;
             Guillain-Barre syndrome.&#xD;
&#xD;
          9. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any&#xD;
             vaccine components.&#xD;
&#xD;
         10. who are known to have a bleeding diathesis, or any condition that may be associated&#xD;
             with a prolonged bleeding time.&#xD;
&#xD;
         11. who are included in study personnel or close family members of personnel conducting&#xD;
             this study.&#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>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neisseria meningitidis, conjugate vaccine, phase IV clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningococcal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lactitol</mesh_term>
  </intervention_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/NCT01705379
org study id: V59_45OB
nct id: NCT01705379
lead sponsor: 
has dmc: No
A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure
      requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety
      evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving
      MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
measure: All adverse events
time frame: Day 29
measure: All serious adverse events
time frame: Day 29
arm group label: MenACWY-CRM
description: 2 years of age and older
intervention type: Biological
intervention name: Novartis Meningococcal ACWY Conjugate Vaccine
description: Immunization
arm group label: MenACWY-CRM
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Meningococcal Infections
mesh term: Lactitol