<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/NCT04440176</url>
  </required_header>
  <id_info>
    <org_study_id>C3511004</org_study_id>
    <secondary_id>2019-004923-19</secondary_id>
    <nct_id>NCT04440176</nct_id>
  </id_info>
  <brief_title>A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules</brief_title>
  <official_title>A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO &lt;15 YEARS OF AGE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to describe the short-term immunogenicity and safety of 2 doses of&#xD;
      Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or&#xD;
      36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses&#xD;
      separated by a 12-month interval.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">March 17, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 17, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants achieving a serum bactericidal assay using human complement (hSBA) titer &gt;= lower limit of quantitation (LLOQ) for 4 primary MenB test strains</measure>
    <time_frame>1 month after second dose of MenABCWY in Group 1</time_frame>
    <description>Describe the immune response for MenB induced by 2 doses of MenABCWY administered on a 0- and 12-month schedule</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants achieving an hSBA titer &gt;= LLOQ for 4 primary MenB test strains</measure>
    <time_frame>1 month after second dose of MenABCWY in Group 2</time_frame>
    <description>Describe the immune response for MenB induced by 2 doses of MenABCWY administered on a 0- and 36-month schedule</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the first MenABCWY vaccination</measure>
    <time_frame>within 30 days after first MenABCWY vaccination</time_frame>
    <description>Describe frequency of AE, SAE, MAE, and NDCMC after first dose of MenABCWY</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the second MenABCWY vaccination</measure>
    <time_frame>within 30 days after second MenABCWY vaccination</time_frame>
    <description>Describe frequency of AE, SAE, MAE, and NDCMC after second dose of MenABCWY</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the placebo vaccination in Group 2</measure>
    <time_frame>within 30 days after placebo vaccination in Group 2</time_frame>
    <description>Describe frequency of AE, SAE, MAE, and NDCMC after placebo vaccination in Group 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after any MenABCWY vaccination</measure>
    <time_frame>within 30 days after any MenABCWY vaccination</time_frame>
    <description>Describe frequency of AE, SAE, MAE, and NDCMC after any dose of MenABCWY</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 vaccination phase</measure>
    <time_frame>from Vaccination 1 through 1 month after Vaccination 1</time_frame>
    <description>Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 1 vaccination phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 vaccination phase</measure>
    <time_frame>from Vaccination 2 through 1 month after Vaccination 2</time_frame>
    <description>Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 2 vaccination phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 3 vaccination phase in Group 2</measure>
    <time_frame>from Vaccination 3 through 1 month after Vaccination 3 in Group 2</time_frame>
    <description>Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 3 vaccination phase in Group 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 follow-up phase</measure>
    <time_frame>from 1 month after Vaccination 1 through 6 months after Vaccination 1</time_frame>
    <description>Describe frequency of SAE, MAE, and NDCMC during the Vaccination 1 follow-up phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 follow-up phase</measure>
    <time_frame>from 1 month after Vaccination 2 through 6 months after Vaccination 2</time_frame>
    <description>Describe frequency of SAE, MAE, and NDCMC during the Vaccination 2 follow-up phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 1</measure>
    <time_frame>from Vaccination 1 through 6 months after Vaccination 1</time_frame>
    <description>Describe frequency of SAE, MAE, and NDCMC within 6 months after Vaccination 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 2</measure>
    <time_frame>from Vaccination 2 through 6 months after Vaccination 2</time_frame>
    <description>Describe frequency of SAE, MAE, and NDCMC within 6 months after Vaccination 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 1</measure>
    <time_frame>within 30 minutes after Vaccination 1</time_frame>
    <description>Describe the frequency of immediate AE after Vaccination 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 2</measure>
    <time_frame>within 30 minutes after Vaccination 2</time_frame>
    <description>Describe the frequency of immediate AE after Vaccination 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 3 in Group 2</measure>
    <time_frame>within 30 minutes after Vaccination 3 in Group 2</time_frame>
    <description>Describe the frequency of immediate AE after Vaccination 3 in Group 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 1</measure>
    <time_frame>within 6 months after Vaccination 1</time_frame>
    <description>Describe frequency of missed days of school or work due to AEs within 6 months after Vaccination 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 2</measure>
    <time_frame>within 6 months after Vaccination 2</time_frame>
    <description>Describe frequency of missed days of school or work due to AEs within 6 months after Vaccination 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting missed days of school or work due to adverse events within 1 month after Vaccination 3 in Group 2</measure>
    <time_frame>within 1 month after Vaccination 3 in Group 2</time_frame>
    <description>Describe frequency of missed days of school or work due to AEs within 1 month after Vaccination 3 in Group 2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer &gt;= lower limit of quantitation (LLOQ) for each ACWY test strain</measure>
    <time_frame>1 month after the first dose of MenABCWY in Group 1</time_frame>
    <description>Describe the immune response for ACWY induced by 1 dose of MenABCWY administered on a 0-, 12-month schedule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer &gt;= lower limit of quantitation (LLOQ) for each ACWY test strain</measure>
    <time_frame>1 month after the first dose of MenABCWY in Group 2</time_frame>
    <description>Describe the immune response for ACWY induced by 1 dose of MenABCWY administered on a 0-, 36-month schedule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer &gt;= lower limit of quantitation (LLOQ) for each ACWY test strain</measure>
    <time_frame>1 month after the second dose of MenABCWY in Group 1</time_frame>
    <description>Describe the immune response for ACWY induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer &gt;= lower limit of quantitation (LLOQ) for each ACWY test strain</measure>
    <time_frame>1 month after the second dose of MenABCWY in Group 2</time_frame>
    <description>Describe the immune response for ACWY induced by 2 doses of MenABCWY administered on a 0-, 36-month schedule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer &gt;= lower limit of quantitation (LLOQ) for 4 primary MenB test strains</measure>
    <time_frame>12 months after the second dose of MenABCWY in Group 1</time_frame>
    <description>Describe the persistence of the MenB immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer &gt;= lower limit of quantitation (LLOQ) for 4 primary MenB test strains</measure>
    <time_frame>24 months after the second dose of MenABCWY in Group 1</time_frame>
    <description>Describe the persistence of the MenB immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer &gt;= lower limit of quantitation (LLOQ) for each ACWY test strain</measure>
    <time_frame>12 months after the second dose of MenABCWY in Group 1</time_frame>
    <description>Describe the persistence of the ACWY immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer &gt;= lower limit of quantitation (LLOQ) for each ACWY test strain</measure>
    <time_frame>24 months after the second dose of MenABCWY in Group 1</time_frame>
    <description>Describe the persistence of the ACWY immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Meningococcal Vaccine</condition>
  <arm_group>
    <arm_group_label>Group 1 (MenABCWY 0-, 12-months)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MenABCWY administered at Month 0 and Month 12</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (MenABCWY 0-, 36-months)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MenABCWY administered at Month 0 and Month 36</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MenABCWY</intervention_name>
    <description>Neisseria meningitidis group A, B, C, W, and Y vaccine</description>
    <arm_group_label>Group 1 (MenABCWY 0-, 12-months)</arm_group_label>
    <arm_group_label>Group 2 (MenABCWY 0-, 36-months)</arm_group_label>
    <other_name>pentavalent meningococcal vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Group 2 (MenABCWY 0-, 36-months)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female participants 11 through &lt;15 years of age at the time of randomization.&#xD;
&#xD;
          -  Participants who have never received a prior dose of any meningococcal vaccine.&#xD;
             Written confirmation of vaccination history must be obtained prior to randomization.&#xD;
&#xD;
          -  Available for the entire study period and can be reached by telephone.&#xD;
&#xD;
          -  Healthy participant as determined by medical history, physical examination, and&#xD;
             judgement of the investigator.&#xD;
&#xD;
          -  Negative urine pregnancy test for all female participants; pregnancy test is not&#xD;
             applicable to male participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A previous anaphylactic reaction to any vaccine or vaccine-related component.&#xD;
&#xD;
          -  Bleeding diathesis or condition associated with prolonged bleeding time that would&#xD;
             contraindicate intramuscular injection.&#xD;
&#xD;
          -  A known or suspected defect of the immune system that would prevent an immune response&#xD;
             to the vaccine, such as participants with congenital or acquired defects in B-cell&#xD;
             function, those receiving chronic systemic (oral, intravenous, or intramuscular)&#xD;
             corticosteroid therapy, or those receiving immunosuppressive therapy.&#xD;
&#xD;
          -  History of microbiologically proven disease caused by Neisseria meningitidis or&#xD;
             Neisseria gonorrhoeae.&#xD;
&#xD;
          -  Significant neurological disorder or history of seizure (excluding simple febrile&#xD;
             seizure).&#xD;
&#xD;
          -  Any neuroinflammatory or autoimmune condition, including, but no limited to,&#xD;
             transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.&#xD;
&#xD;
          -  Participants receiving any allergen immunotherapy with a nonlicensed product or&#xD;
             receiving allergen immunotherapy with a licensed product and are not on stable&#xD;
             maintenance doses.&#xD;
&#xD;
          -  Receipt of any blood products, including immunoglobulin, within 6 months before the&#xD;
             first study vaccination.&#xD;
&#xD;
          -  Current use of systemic antibiotics with no foreseeable date of discontinuation prior&#xD;
             to anticipated date of enrollment (first vaccination).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alliance for Multispecialty Research, LLC</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Research Foundation</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nona Pediatric Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32829</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229-3039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Pediatric Research Association Inc.</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Health Resources</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostics Research Group</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wee Care Pediatrics</name>
      <address>
        <city>Kaysville</city>
        <state>Utah</state>
        <zip>84037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wasatch Pediatrics, Cottonwood Office</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Valley Pediatrics - Timpanogos Office</name>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wee Care Pediatrics</name>
      <address>
        <city>Roy</city>
        <state>Utah</state>
        <zip>84067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research, Inc. / Foothill Family Clinic</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research, Inc. / Foothill Family Clinic South</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CopperView Medical Center</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wee Care Pediatrics</name>
      <address>
        <city>Syracuse</city>
        <state>Utah</state>
        <zip>84075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Research of Charlottesville, LLC</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=C3511004</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>September 22, 2022</last_update_submitted>
  <last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pentavalent meningococcal vaccine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <!-- 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/NCT04440176
org study id: C3511004
secondary id: 2019-004923-19
nct id: NCT04440176
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is designed to describe the short-term immunogenicity and safety of 2 doses of
      Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or
      36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses
      separated by a 12-month interval.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of participants achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains
time frame: 1 month after second dose of MenABCWY in Group 1
description: Describe the immune response for MenB induced by 2 doses of MenABCWY administered on a 0- and 12-month schedule
measure: Percentage of participants achieving an hSBA titer >= LLOQ for 4 primary MenB test strains
time frame: 1 month after second dose of MenABCWY in Group 2
description: Describe the immune response for MenB induced by 2 doses of MenABCWY administered on a 0- and 36-month schedule
measure: Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the first MenABCWY vaccination
time frame: within 30 days after first MenABCWY vaccination
description: Describe frequency of AE, SAE, MAE, and NDCMC after first dose of MenABCWY
measure: Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the second MenABCWY vaccination
time frame: within 30 days after second MenABCWY vaccination
description: Describe frequency of AE, SAE, MAE, and NDCMC after second dose of MenABCWY
measure: Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the placebo vaccination in Group 2
time frame: within 30 days after placebo vaccination in Group 2
description: Describe frequency of AE, SAE, MAE, and NDCMC after placebo vaccination in Group 2
measure: Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after any MenABCWY vaccination
time frame: within 30 days after any MenABCWY vaccination
description: Describe frequency of AE, SAE, MAE, and NDCMC after any dose of MenABCWY
measure: Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 vaccination phase
time frame: from Vaccination 1 through 1 month after Vaccination 1
description: Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 1 vaccination phase
measure: Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 vaccination phase
time frame: from Vaccination 2 through 1 month after Vaccination 2
description: Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 2 vaccination phase
measure: Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 3 vaccination phase in Group 2
time frame: from Vaccination 3 through 1 month after Vaccination 3 in Group 2
description: Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 3 vaccination phase in Group 2
measure: Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 follow-up phase
time frame: from 1 month after Vaccination 1 through 6 months after Vaccination 1
description: Describe frequency of SAE, MAE, and NDCMC during the Vaccination 1 follow-up phase
measure: Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 follow-up phase
time frame: from 1 month after Vaccination 2 through 6 months after Vaccination 2
description: Describe frequency of SAE, MAE, and NDCMC during the Vaccination 2 follow-up phase
measure: Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 1
time frame: from Vaccination 1 through 6 months after Vaccination 1
description: Describe frequency of SAE, MAE, and NDCMC within 6 months after Vaccination 1
measure: Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 2
time frame: from Vaccination 2 through 6 months after Vaccination 2
description: Describe frequency of SAE, MAE, and NDCMC within 6 months after Vaccination 2
measure: Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 1
time frame: within 30 minutes after Vaccination 1
description: Describe the frequency of immediate AE after Vaccination 1
measure: Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 2
time frame: within 30 minutes after Vaccination 2
description: Describe the frequency of immediate AE after Vaccination 2
measure: Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 3 in Group 2
time frame: within 30 minutes after Vaccination 3 in Group 2
description: Describe the frequency of immediate AE after Vaccination 3 in Group 2
measure: Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 1
time frame: within 6 months after Vaccination 1
description: Describe frequency of missed days of school or work due to AEs within 6 months after Vaccination 1
measure: Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 2
time frame: within 6 months after Vaccination 2
description: Describe frequency of missed days of school or work due to AEs within 6 months after Vaccination 2
measure: Percentage of participants reporting missed days of school or work due to adverse events within 1 month after Vaccination 3 in Group 2
time frame: within 1 month after Vaccination 3 in Group 2
description: Describe frequency of missed days of school or work due to AEs within 1 month after Vaccination 3 in Group 2
measure: Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain
time frame: 1 month after the first dose of MenABCWY in Group 1
description: Describe the immune response for ACWY induced by 1 dose of MenABCWY administered on a 0-, 12-month schedule
measure: Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain
time frame: 1 month after the first dose of MenABCWY in Group 2
description: Describe the immune response for ACWY induced by 1 dose of MenABCWY administered on a 0-, 36-month schedule
measure: Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain
time frame: 1 month after the second dose of MenABCWY in Group 1
description: Describe the immune response for ACWY induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule
measure: Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain
time frame: 1 month after the second dose of MenABCWY in Group 2
description: Describe the immune response for ACWY induced by 2 doses of MenABCWY administered on a 0-, 36-month schedule
measure: Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains
time frame: 12 months after the second dose of MenABCWY in Group 1
description: Describe the persistence of the MenB immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule
measure: Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains
time frame: 24 months after the second dose of MenABCWY in Group 1
description: Describe the persistence of the MenB immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule
measure: Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain
time frame: 12 months after the second dose of MenABCWY in Group 1
description: Describe the persistence of the ACWY immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule
measure: Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain
time frame: 24 months after the second dose of MenABCWY in Group 1
description: Describe the persistence of the ACWY immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule
arm group label: Group 1 (MenABCWY 0-, 12-months)
arm group type: Experimental
description: MenABCWY administered at Month 0 and Month 12
arm group label: Group 2 (MenABCWY 0-, 36-months)
arm group type: Experimental
description: MenABCWY administered at Month 0 and Month 36
intervention type: Biological
intervention name: MenABCWY
description: Neisseria meningitidis group A, B, C, W, and Y vaccine
arm group label: Group 1 (MenABCWY 0-, 12-months)
arm group label: Group 2 (MenABCWY 0-, 36-months)
other name: pentavalent meningococcal vaccine
intervention type: Biological
intervention name: Saline
description: Placebo
arm group label: Group 2 (MenABCWY 0-, 36-months)
criteria: 
gender: All
minimum age: 11 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=C3511004
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Vaccines
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests