<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/NCT03803202</url>
  </required_header>
  <id_info>
    <org_study_id>3772-CL-1001</org_study_id>
    <nct_id>NCT03803202</nct_id>
  </id_info>
  <brief_title>A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine</brief_title>
  <official_title>A Phase 1/2, Randomized, Single Ascending Dose Study in Adults (Stage 1) and Randomized, Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, a Pneumococcal Vaccine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affinivax, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Affinivax, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of 3&#xD;
      different dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13)&#xD;
      in adults 18 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability,&#xD;
      and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active&#xD;
      comparator PCV13 in elderly 65 to 85 years of age. In addition, Stage 2 will evaluate the&#xD;
      immunogenicity of 3 different dose levels of ASP3772 relative to the response seen following&#xD;
      administration of Pneumovax® 23 (PPSV23) for the serotypes not included in PCV13.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study population will consist of 3 different groups: Group 1 - Stage 1 PCV13 naïve&#xD;
      participants randomized within 3 sequential cohorts to ASP3772 or PCV13; Group 2 - Stage 2&#xD;
      PCV13 naïve participants randomized within 3 sequential cohorts to ASP3772 or PCV13; and&#xD;
      Group 3 - Stage 2 participants previously vaccinated with PCV13 that will receive PPSV23.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Actual">September 28, 2020</completion_date>
  <primary_completion_date type="Actual">September 28, 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants reporting treatment emergent adverse events (TEAEs) including serious AEs (SAEs), medically attended adverse events (MAAEs), potentially immune mediated medical conditions (PIMMCs) and new onset chronic diseases (NOCDs)</measure>
    <time_frame>Up to Day 180</time_frame>
    <description>Percentage of participants with adverse events (AEs), SAEs, MAAEs including NOCDs, and PIMMCs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants experiencing abnormal vital signs</measure>
    <time_frame>Up to Day 30</time_frame>
    <description>Percentage of participants with potentially clinically significant vital sign values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting solicited systemic adverse reactions for up to 7 days after vaccination</measure>
    <time_frame>Up to Day 7</time_frame>
    <description>Systemic reactions include nausea/vomiting, diarrhea, headache, fever, fatigue, joint pain/arthralgia and muscle discomfort or pain/myalgia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants reporting solicited local adverse reactions for up to 7 days after vaccination</measure>
    <time_frame>Up to Day 7</time_frame>
    <description>Local reactions include pain, tenderness, redness/erythema, and swelling/induration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with laboratory value abnormalities and/or adverse events (AEs)</measure>
    <time_frame>Up to Day 30</time_frame>
    <description>Percentage of participants with potentially clinically significant laboratory values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with physical examination abnormalities and/or adverse events (AEs)</measure>
    <time_frame>Up to Day 30</time_frame>
    <description>Percentage of participants with potentially clinically significant physical examination values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety assessed by 12-lead electrocardiogram (ECG)</measure>
    <time_frame>Up to Day 30</time_frame>
    <description>A 12-lead, resting is to be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunological response of PCV13 at Day 30</measure>
    <time_frame>Day 30</time_frame>
    <description>Immunological response of PCV13 will be determined at Day 30 (Stage 1, Group 1 and Stage 2, Group 2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunological response of ASP3772 at Day 30</measure>
    <time_frame>Day 30</time_frame>
    <description>Immunological response of ASP3772 will be determined at Day 30 (Stage 1, Group 1 and Stage 2, Group 2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunological response of PPSV23 at Day 30</measure>
    <time_frame>Day 30</time_frame>
    <description>Immunological response of PPSV23 will be determined at Day 30 (Stage 2, Group 3).</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">630</enrollment>
  <condition>Healthy Volunteers</condition>
  <condition>Pneumococcal Disease</condition>
  <arm_group>
    <arm_group_label>Stage 1, Group 1 ASP3772 in Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1, Group 1 PCV13 in Adults</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive a single intramuscular injection of the standard dose of PCV13 on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2, Group 2 ASP3772 in Elderly</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2, Group 2 PCV13 in Elderly</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive a single intramuscular injection of the standard dose of PCV13 on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2, Group 3 PPSV23 in Elderly</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive a single intramuscular injection of the standard dose of PPSV23 on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ASP3772</intervention_name>
    <description>Intramuscular Injection</description>
    <arm_group_label>Stage 1, Group 1 ASP3772 in Adults</arm_group_label>
    <arm_group_label>Stage 2, Group 2 ASP3772 in Elderly</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PCV13</intervention_name>
    <description>Intramuscular Injection</description>
    <arm_group_label>Stage 1, Group 1 PCV13 in Adults</arm_group_label>
    <arm_group_label>Stage 2, Group 2 PCV13 in Elderly</arm_group_label>
    <other_name>Prevnar 13</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PPSV23</intervention_name>
    <description>Intramuscular Injection</description>
    <arm_group_label>Stage 2, Group 3 PPSV23 in Elderly</arm_group_label>
    <other_name>Pneumovax 23</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage 1: Subject is healthy male or female between 18 and 64 year of age inclusive, at&#xD;
             screening.&#xD;
&#xD;
          -  Stage 2: Subject is a male or female between 65 and 85 years of age, inclusive, at&#xD;
             screening who is healthy or has chronic controlled, stable disease with no change in&#xD;
             disease severity, medical therapy and no hospitalization records in last 12 weeks as&#xD;
             determined by medical history, physical examination and laboratory data.&#xD;
&#xD;
          -  A female subject is eligible to participate if not pregnant and at least 1 of the&#xD;
             following conditions applies:&#xD;
&#xD;
               -  Not a woman of childbearing potential (WOCBP) OR&#xD;
&#xD;
               -  WOCBP who agrees to follow the contraceptive guidance at screening and for at&#xD;
                  least 28 days after the study vaccine administration.&#xD;
&#xD;
          -  Female subject must agree not to breastfeed starting at screening and for 28 days&#xD;
             after the study vaccine administration.&#xD;
&#xD;
          -  Female subject must not donate ova starting at screening and for 28 days after the&#xD;
             study vaccine administration.&#xD;
&#xD;
          -  A male subject with female partner(s) of childbearing potential must agree to use&#xD;
             contraception at screening and for at least 28 days after the study vaccine&#xD;
             administration.&#xD;
&#xD;
          -  Male subject must not donate sperm starting at screening and for 90 days after the&#xD;
             study vaccine administration.&#xD;
&#xD;
          -  Male subject with a pregnant or breastfeeding partner(s) must agree to remain&#xD;
             abstinent or use a condom for the duration of the pregnancy or time partner is&#xD;
             breastfeeding at screening and for 28 after the study vaccine administration.&#xD;
&#xD;
          -  Subject agrees not to participate in another interventional study while participating&#xD;
             in the present study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a known or suspected hypersensitivity to ASP3772, its comparators or any&#xD;
             components of the formulations used.&#xD;
&#xD;
          -  Subject has had previous exposure with ASP3772.&#xD;
&#xD;
          -  Subject has had known previous exposure with PPSV23.&#xD;
&#xD;
          -  Subject has received PCV13 or any other licensed or investigational pneumococcal&#xD;
             vaccine at any time. (Note: This exclusion criterion is not applicable to Group 3;&#xD;
             those subjects 65 to 85 years of age who previously received immunization with PCV13.&#xD;
             Prior PCV13 immunization should have taken place no less than 10 months and no more&#xD;
             than 2 years prior to study vaccine administration. These subjects are eligible to be&#xD;
             enrolled in the nonrandomized arm of Stage 2, Group 3.&#xD;
&#xD;
          -  Subject has a history of microbiologically-proven invasive disease caused by S.&#xD;
             pneumoniae.&#xD;
&#xD;
          -  Subject has an immune disorder(s) (including autoimmune disease) and/or clinical&#xD;
             conditions requiring immunosuppressive drugs.&#xD;
&#xD;
          -  Subject has any evidence of any unstable or active clinically significant&#xD;
             cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic,&#xD;
             metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or&#xD;
             other major disease or malignancy, e.g., uncontrolled hypertension, uncontrolled&#xD;
             diabetes, heart failure, uncontrolled chronic obstructive pulmonary disease, end-stage&#xD;
             renal disease.&#xD;
&#xD;
          -  Subject has history of illicit drug(s) or alcohol abuse that will interfere with the&#xD;
             protocol requirements and/or a positive urine drug test (for Stage 1 subjects only) at&#xD;
             screening.&#xD;
&#xD;
          -  Subject has any clinically significant history of allergic conditions including drug&#xD;
             allergies, asthma or anaphylactic reactions, but excluding untreated asymptomatic&#xD;
             seasonal allergies prior to study vaccine administration.&#xD;
&#xD;
          -  Subject has a coagulation disorder contraindicating intramuscular immunization.&#xD;
&#xD;
          -  Subject has a positive serology test for hepatitis B surface antigen (HBsAg),&#xD;
             hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies&#xD;
             (anti-HCV) confirmed by reflex testing (HCV-RNA) or antibodies to human&#xD;
             immunodeficiency virus (HIV) type 1 and/or type 2 at screening.&#xD;
&#xD;
          -  Subject has/had febrile illness (&gt; 100.4°F oral equivalent) or symptomatic, viral,&#xD;
             bacterial (including upper respiratory infection) or fungal (noncutaneous) infection&#xD;
             within 1 week prior to day 1.&#xD;
&#xD;
          -  Subject has any clinically significant abnormality from the physical examination, ECG&#xD;
             and clinical laboratory tests during screening.&#xD;
&#xD;
          -  Subject is unlikely to adhere to study procedures, keep appointments, is planning to&#xD;
             relocate during the study or cannot be adequately followed for safety according to the&#xD;
             protocol.&#xD;
&#xD;
          -  Subject has any other condition, which precludes the subject's participation in the&#xD;
             study.&#xD;
&#xD;
          -  Subject has received any vaccines within 30 days prior of receipt of the study vaccine&#xD;
             (exception: Influenza virus vaccine given according to recommended guidelines must be&#xD;
             given at least 7 days prior to receiving study vaccine).&#xD;
&#xD;
          -  Subject has had significant blood loss, donated 1 unit (450 mL or more) or received&#xD;
             transfusion of any blood or blood products within 60 days or donated plasma within 7&#xD;
             days prior to day 1.&#xD;
&#xD;
          -  Subject has received any systemically absorbed antibiotics during the 7-day period&#xD;
             prior to day 1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advanced Clinical Research-Rancho Paseo</name>
      <address>
        <city>Banning</city>
        <state>California</state>
        <zip>92220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Artemis Institute</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Artemis Institute</name>
      <address>
        <city>San Marcos</city>
        <state>California</state>
        <zip>92078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centers of America</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sundance Clinical Research</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Medical Associates</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Raleigh</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Hickory, LLC</name>
      <address>
        <city>Rocky Mount</city>
        <state>North Carolina</state>
        <zip>27804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont HealthCare, PA</name>
      <address>
        <city>Statesville</city>
        <state>North Carolina</state>
        <zip>28625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmington Health</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Winston-Salem, LLC</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research - George Town</name>
      <address>
        <city>Yukon</city>
        <state>Oklahoma</state>
        <zip>73099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37938</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research Institute</name>
      <address>
        <city>Cedar Park</city>
        <state>Texas</state>
        <zip>78613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Healthcare, PLLC</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</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 Center for Drug Development</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare Associatiates of Texas</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DM Clinical Research</name>
      <address>
        <city>Pearland</city>
        <state>Texas</state>
        <zip>77584</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research</name>
      <address>
        <city>San Angelo</city>
        <state>Texas</state>
        <zip>76904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martin Diagnostic Clinic</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRA of Tidewater Inc</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <disposition_first_submitted>September 27, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>September 27, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 29, 2021</disposition_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pneumococcal vaccine</keyword>
  <keyword>Vaccine</keyword>
  <keyword>Pneumococccal Disease</keyword>
  <keyword>ASP3772</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumococcal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.</ipd_time_frame>
    <ipd_access_criteria>Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.</ipd_access_criteria>
    <ipd_url>https://www.clinicalstudydatarequest.com/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03803202
org study id: 3772-CL-1001
nct id: NCT03803202
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of 3
      different dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13)
      in adults 18 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability,
      and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active
      comparator PCV13 in elderly 65 to 85 years of age. In addition, Stage 2 will evaluate the
      immunogenicity of 3 different dose levels of ASP3772 relative to the response seen following
      administration of Pneumovax® 23 (PPSV23) for the serotypes not included in PCV13.
The study population will consist of 3 different groups: Group 1 - Stage 1 PCV13 naïve
      participants randomized within 3 sequential cohorts to ASP3772 or PCV13; Group 2 - Stage 2
      PCV13 naïve participants randomized within 3 sequential cohorts to ASP3772 or PCV13; and
      Group 3 - Stage 2 participants previously vaccinated with PCV13 that will receive PPSV23.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Percentage of participants reporting treatment emergent adverse events (TEAEs) including serious AEs (SAEs), medically attended adverse events (MAAEs), potentially immune mediated medical conditions (PIMMCs) and new onset chronic diseases (NOCDs)
time frame: Up to Day 180
description: Percentage of participants with adverse events (AEs), SAEs, MAAEs including NOCDs, and PIMMCs.
measure: Percentage of participants experiencing abnormal vital signs
time frame: Up to Day 30
description: Percentage of participants with potentially clinically significant vital sign values.
measure: Percentage of participants reporting solicited systemic adverse reactions for up to 7 days after vaccination
time frame: Up to Day 7
description: Systemic reactions include nausea/vomiting, diarrhea, headache, fever, fatigue, joint pain/arthralgia and muscle discomfort or pain/myalgia.
measure: Percentage of participants reporting solicited local adverse reactions for up to 7 days after vaccination
time frame: Up to Day 7
description: Local reactions include pain, tenderness, redness/erythema, and swelling/induration.
measure: Percentage of participants with laboratory value abnormalities and/or adverse events (AEs)
time frame: Up to Day 30
description: Percentage of participants with potentially clinically significant laboratory values.
measure: Percentage of participants with physical examination abnormalities and/or adverse events (AEs)
time frame: Up to Day 30
description: Percentage of participants with potentially clinically significant physical examination values.
measure: Safety assessed by 12-lead electrocardiogram (ECG)
time frame: Up to Day 30
description: A 12-lead, resting is to be recorded.
measure: Immunological response of PCV13 at Day 30
time frame: Day 30
description: Immunological response of PCV13 will be determined at Day 30 (Stage 1, Group 1 and Stage 2, Group 2).
measure: Immunological response of ASP3772 at Day 30
time frame: Day 30
description: Immunological response of ASP3772 will be determined at Day 30 (Stage 1, Group 1 and Stage 2, Group 2).
measure: Immunological response of PPSV23 at Day 30
time frame: Day 30
description: Immunological response of PPSV23 will be determined at Day 30 (Stage 2, Group 3).
arm group label: Stage 1, Group 1 ASP3772 in Adults
arm group type: Experimental
description: Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels.
arm group label: Stage 1, Group 1 PCV13 in Adults
arm group type: Active Comparator
description: Participants will receive a single intramuscular injection of the standard dose of PCV13 on Day 1.
arm group label: Stage 2, Group 2 ASP3772 in Elderly
arm group type: Experimental
description: Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels
arm group label: Stage 2, Group 2 PCV13 in Elderly
arm group type: Active Comparator
description: Participants will receive a single intramuscular injection of the standard dose of PCV13 on Day 1.
arm group label: Stage 2, Group 3 PPSV23 in Elderly
arm group type: Active Comparator
description: Participants will receive a single intramuscular injection of the standard dose of PPSV23 on Day 1.
intervention type: Biological
intervention name: ASP3772
description: Intramuscular Injection
arm group label: Stage 1, Group 1 ASP3772 in Adults
arm group label: Stage 2, Group 2 ASP3772 in Elderly
intervention type: Biological
intervention name: PCV13
description: Intramuscular Injection
arm group label: Stage 1, Group 1 PCV13 in Adults
arm group label: Stage 2, Group 2 PCV13 in Elderly
other name: Prevnar 13
intervention type: Biological
intervention name: PPSV23
description: Intramuscular Injection
arm group label: Stage 2, Group 3 PPSV23 in Elderly
other name: Pneumovax 23
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Pneumococcal Infections
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: Yes
ipd description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
ipd access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
ipd url: https://www.clinicalstudydatarequest.com/