<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/NCT01689155</url>
  </required_header>
  <id_info>
    <org_study_id>MTA57</org_study_id>
    <secondary_id>U 1111-1120-1574</secondary_id>
    <nct_id>NCT01689155</nct_id>
  </id_info>
  <brief_title>Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children</brief_title>
  <official_title>Post-licensure Safety Surveillance Study of Menactra® Vaccine When Administered As a 2-dose Schedule to Children 9 Months Through 23 Months of Age.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a passive-surveillance study that will accrue subjects for surveillance. For each&#xD;
      accrued subject, surveillance for outcomes will continue for six months following the first&#xD;
      dose. If a second dose is given within that time, then surveillance will be continued for six&#xD;
      months following the second dose.&#xD;
&#xD;
      Observational Objective:&#xD;
&#xD;
        -  To describe and characterize adverse events occurring after vaccination with Menactra&#xD;
           vaccine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be carried out in collaboration with the Kaiser Permanente Medical Care&#xD;
      Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC).&#xD;
      KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter&#xD;
      databases that capture all medical care received by enrollees.&#xD;
&#xD;
      Vaccination will be according to routine clinical practice. Vaccination databases will be&#xD;
      reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.</measure>
    <time_frame>Day 0 up to Day 75 post-vaccination</time_frame>
    <description>Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database.</measure>
    <time_frame>Day 0 up to Day 75 post-vaccination</time_frame>
    <description>Incidence rates for identified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Note: No events were identified in the hospital database.</description>
  </other_outcome>
  <other_outcome>
    <measure>Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database.</measure>
    <time_frame>Day 0 up to Day 75 post-vaccination</time_frame>
    <description>Incidence rates for pre-specified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">116</enrollment>
  <condition>Meningitis</condition>
  <condition>Meningococcal Infection</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>Participants must have received Menactra Vaccine according to routine clinical practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate</intervention_name>
    <description>0.5 mL, Intramuscular</description>
    <arm_group_label>Study Group</arm_group_label>
    <other_name>Menactra®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants at age 9 to 23 months at the time of receipt of the first dose of Menactra&#xD;
        vaccine according to routine clinical practice during the study period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during&#xD;
             the study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>23 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.sanofipasteur.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>August 1, 2016</results_first_submitted>
  <results_first_submitted_qc>September 25, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 11, 2016</results_first_posted>
  <last_update_submitted>September 25, 2016</last_update_submitted>
  <last_update_submitted_qc>September 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Meningitis</keyword>
  <keyword>Meningococcal Infection</keyword>
  <keyword>Menactra®</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningococcal Infections</mesh_term>
    <mesh_term>Meningitis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study participant accrual occurred from 16 June 2011 through 20 June 2014.</recruitment_details>
      <pre_assignment_details>Databases of Kaiser Permanente in Northern California (KPNC) were reviewed to describe and characterize adverse events occurring after use of Menactra vaccine in routine clinical practice. Rates of events occurring in a risk window for participants were compared with rates of events occurring in a control window for the same participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Menactra Vaccine Recipients</title>
          <description>Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants age 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.</population>
      <group_list>
        <group group_id="B1">
          <title>Menactra Vaccine Recipients</title>
          <description>Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="116"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.9" spread="5.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Seasonality</title>
          <description>Data represent participants receiving vaccine during time period shown. Four participants received 2 doses of Menactra; each dose is accounted for in the appropriate time period.</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>December - February</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>March - May</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>June - August</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>September - November</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.</title>
        <description>Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.</description>
        <time_frame>Day 0 up to Day 75 post-vaccination</time_frame>
        <population>Eligible participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Menactra Vaccine Recipients</title>
            <description>Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.</title>
          <description>Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.</description>
          <population>Eligible participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.</population>
          <units>Events per 1,000 person-months</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Asthma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009"/>
                    <measurement group_id="O2" value="0.006"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cough</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009"/>
                    <measurement group_id="O2" value="0.006"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Febrile Seizure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009"/>
                    <measurement group_id="O2" value="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Otitis Media</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009"/>
                    <measurement group_id="O2" value="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trauma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.019"/>
                    <measurement group_id="O2" value="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper Respiratory Infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009"/>
                    <measurement group_id="O2" value="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Viral Syndrome</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009"/>
                    <measurement group_id="O2" value="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting (ER)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009"/>
                    <measurement group_id="O2" value="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database.</title>
        <description>Incidence rates for identified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Note: No events were identified in the hospital database.</description>
        <time_frame>Day 0 up to Day 75 post-vaccination</time_frame>
        <population>All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Menactra Vaccine Recipients</title>
            <description>Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database.</title>
          <description>Incidence rates for identified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Note: No events were identified in the hospital database.</description>
          <population>All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.</population>
          <units>Events per 1,000 person-months</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database.</title>
        <description>Incidence rates for pre-specified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database.</description>
        <time_frame>Day 0 up to Day 75 post-vaccination</time_frame>
        <population>All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Menactra Vaccine Recipients</title>
            <description>Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database.</title>
          <description>Incidence rates for pre-specified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database.</description>
          <population>All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.</population>
          <units>Events per 1,000 person-months</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Surveillance period for adverse events was from the day of vaccination to 6 months post-final vaccination, an average of 6 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Menactra Vaccine Recipients</title>
          <description>Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5.0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Drector</name_or_title>
      <organization>Sanofi Pasteur Inc</organization>
      <email>RegistryContactus@sanofipasteur.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01689155
org study id: MTA57
secondary id: U 1111-1120-1574
nct id: NCT01689155
lead sponsor: 
has dmc: No
This is a passive-surveillance study that will accrue subjects for surveillance. For each
      accrued subject, surveillance for outcomes will continue for six months following the first
      dose. If a second dose is given within that time, then surveillance will be continued for six
      months following the second dose.

      Observational Objective:

        -  To describe and characterize adverse events occurring after vaccination with Menactra
           vaccine.
The study will be carried out in collaboration with the Kaiser Permanente Medical Care
      Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC).
      KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter
      databases that capture all medical care received by enrollees.

      Vaccination will be according to routine clinical practice. Vaccination databases will be
      reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.
observational model: Cohort
time perspective: Prospective
measure: Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.
time frame: Day 0 up to Day 75 post-vaccination
description: Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.
measure: Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database.
time frame: Day 0 up to Day 75 post-vaccination
description: Incidence rates for identified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Note: No events were identified in the hospital database.
measure: Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database.
time frame: Day 0 up to Day 75 post-vaccination
description: Incidence rates for pre-specified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database.
arm group label: Study Group
description: Participants must have received Menactra Vaccine according to routine clinical practice.
intervention type: Biological
intervention name: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
description: 0.5 mL, Intramuscular
arm group label: Study Group
other name: Menactra®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 9 Months
maximum age: 23 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur Inc.
facility: 
country: United States
url: http://www.sanofipasteur.com
description: Related Info
responsible party type: Sponsor
mesh term: Meningococcal Infections
mesh term: Meningitis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 