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Astellas Study ID
3772-CL-1001

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

Astellas Study ID
3772-CL-1001
Clinicaltrials.gov ID
NCT03803202
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

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.

Additional Study Details

Phase
1/2
Product
N/A
Product
N/A
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment number
630
Show Additional Study Details

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Would you like more information about clinical trial sites that are recruiting participants for 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? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
  • A healthcare provider
  • A parent
  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

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    Locations

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    Completed
    PMG Research
    Knoxville, TN, United States, 37938
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    Completed
    Benchmark Research
    San Angelo, TX, United States, 76904
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    Completed
    PMG Research of Winston-Salem, LLC
    Winston-Salem, NC, United States, 27103
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    Completed
    Advanced Clinical Research-Rancho Paseo
    Banning, CA, United States, 92220
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    Completed
    Advanced Clinical Research Institute
    Cedar Park, TX, United States, 78613
    Contact Us
    Completed
    Artemis Institute
    San Marcos, CA, United States, 92078
    Contact Us
    Completed
    Sundance Clinical Research
    St. Louis, Mo, United States, 63141
    Contact Us
    Completed
    Martin Diagnostic Clinic
    Tomball, TX, United States, 77375
    Contact Us
    Completed
    Healthcare Associatiates of Texas
    McKinney, TX, United States, 75070
    Contact Us
    Completed
    Tekton Research - George Town
    Yukon, OK, United States, 73099
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    Suspended
    United Medical Associates
    Binghamton, NY, United States, 13901
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    Completed
    Meridian Clinical Research
    Norfolk, NE, United States, 68701
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    Completed
    PMG Research
    Knoxville, TN, United States, 37912
    Contact Us
    Completed
    PMG Research of Hickory, LLC
    Rocky Mount, NC, United States, 27804
    Contact Us
    Completed
    Meridian Clinical Research
    Savannah, GA, United States, 31406
    Contact Us
    Completed
    DM Clinical Research
    Pearland, TX, United States, 77584
    Contact Us
    Completed
    Wilmington Health
    Wilmington, NC, United States, 28401
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    Completed
    Artemis Institute
    San Diego, CA, United States, 92103
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    Withdrawn
    Clinical Research of Atlanta
    Griffin, GA, United States, 30224
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    Completed
    Benchmark Research
    Fort Worth, TX, United States, 76135
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    Completed
    Texas Center for Drug Development
    Houston, TX, United States, 77081
    Contact Us
    Completed
    PMG Research of Raleigh
    Raleigh, NC, United States, 27604
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    Completed
    CRA of Tidewater Inc
    Norfolk, VA, United States, 23507
    Contact Us
    Completed
    Piedmont HealthCare, PA
    Statesville, NC, United States, 28625
    Contact Us
    Completed
    Research Centers of America
    Hollywood, FL, United States, 33024
    Contact Us
    Completed
    Texas Healthcare, PLLC
    Fort Worth, TX, United States, 76104
    Contact Us
    Completed
    Clinical Trials of Texas
    San Antonio, TX, United States, 78229
    Contact Us
    Trial info
    Follow Trial
    Age
    18 - 85 years
    Diamond icon
    Condition
  • Healthy Volunteer
    • Show more
  • Bacterial Infections
    • Gender icon
    Sex
    Female & Male
    Calendar icon
    Trial Dates
    Jan 2019 - Sep 2020
    Additional Study Details
    Inclusion Criteria
    • Stage 1: Subject is healthy male or female between 18 and 64 year of age inclusive, at screening.
    • Stage 2: Subject is a male or female between 65 and 85 years of age, inclusive, at screening who is healthy or has chronic controlled, stable disease with no change in disease severity, medical therapy and no hospitalization records in last 12 weeks as determined by medical history, physical examination and laboratory data.
    • A female subject is eligible to participate if not pregnant and at least 1 of the following conditions applies:
      • Not a woman of childbearing potential (WOCBP)

      • OR

    • WOCBP who agrees to follow the contraceptive guidance at screening and for at least 28 days after the study vaccine administration.
    • Female subject must agree not to breastfeed starting at screening and for 28 days after the study vaccine administration.
    • Female subject must not donate ova starting at screening and for 28 days after the study vaccine administration.
    • A male subject with female partner(s) of childbearing potential must agree to use contraception at screening and for at least 28 days after the study vaccine administration.
    • Male subject must not donate sperm starting at screening and for 90 days after the study vaccine administration.
    • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding at screening and for 28 after the study vaccine administration.
    • Subject agrees not to participate in another interventional study while participating in the present study.
    MaximizeExclusion Criteria
    • Subject has a known or suspected hypersensitivity to ASP3772, its comparators or any components of the formulations used.
    • Subject has had previous exposure with ASP3772.
    • Subject has had known previous exposure with PPSV23.
    • Subject has received PCV13 or any other licensed or investigational pneumococcal vaccine at any time. (Note: This exclusion criterion is not applicable to Group 3; those subjects 65 to 85 years of age who previously received immunization with PCV13. Prior PCV13 immunization should have taken place no less than 10 months and no more than 2 years prior to study vaccine administration. These subjects are eligible to be enrolled in the nonrandomized arm of Stage 2, Group 3.
    • Subject has a history of microbiologically-proven invasive disease caused by S. pneumoniae.
    • Subject has an immune disorder(s) (including autoimmune disease) and/or clinical conditions requiring immunosuppressive drugs.
    • Subject has any evidence of any unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, e.g., uncontrolled hypertension, uncontrolled diabetes, heart failure, uncontrolled chronic obstructive pulmonary disease, end-stage renal disease.
    • Subject has history of illicit drug(s) or alcohol abuse that will interfere with the protocol requirements and/or a positive urine drug test (for Stage 1 subjects only) at screening.
    • Subject has any clinically significant history of allergic conditions including drug allergies, asthma or anaphylactic reactions, but excluding untreated asymptomatic seasonal allergies prior to study vaccine administration.
    • Subject has a coagulation disorder contraindicating intramuscular immunization.
    • Subject has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies (anti-HCV) confirmed by reflex testing (HCV-RNA) or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening.
    • Subject has/had febrile illness (> 100.4°F oral equivalent) or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day 1.
    • Subject has any clinically significant abnormality from the physical examination, ECG and clinical laboratory tests during screening.
    • Subject is unlikely to adhere to study procedures, keep appointments, is planning to relocate during the study or cannot be adequately followed for safety according to the protocol.
    • Subject has any other condition, which precludes the subject’s participation in the study.
    • Subject has received any vaccines within 30 days prior of receipt of the study vaccine

      • (exception: Influenza virus vaccine given according to recommended guidelines must be given at least 7 days prior to receiving study vaccine).

    • Subject has had significant blood loss, donated 1 unit (450 mL or more) or received transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to day 1.
    • Subject has received any systemically absorbed antibiotics during the 7-day period prior to day 1.

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