A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator
NCT ID: NCT04525599
Last Updated: 2022-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
75 participants
INTERVENTIONAL
2020-09-22
2022-04-06
Brief Summary
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This study will also evaluate the immunogenicity (production of an immune response) of three different dose levels of ASP3772 in comparison to the active comparator PCV13 in toddlers who have previously been administered the routine three-dose series of PCV13.
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Detailed Description
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All participants will have study visits on Day 7 (+ 1 day) and Day 30 (± 5 days) post-vaccination. The Day 7 visit may be conducted on site or by telephone call.The end-of-study visit will occur on Day 180 (± 14 days), which will be a safety follow-up by telephone call.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
DOUBLE
Study Groups
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Group 1, ASP3772 Low Dose
Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a low-dose level.
ASP3772
Intramuscular (IM) injection
Group 1, PCV13 Comparator
Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.
PCV13
Intramuscular injection
Group 2, ASP3772 Medium Dose
Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a medium-dose level.
ASP3772
Intramuscular (IM) injection
Group 2, PCV13 Comparator
Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.
PCV13
Intramuscular injection
Group 3, ASP3772 High Dose
Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a high-dose level.
ASP3772
Intramuscular (IM) injection
Group 3, PCV13 Comparator
Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.
PCV13
Intramuscular injection
Interventions
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ASP3772
Intramuscular (IM) injection
PCV13
Intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is afebrile within the last 48 hours (temperature measured orally is \< 100 °F \[37.8°C\]; measured rectally or tympanic is \< 101 °F \[38.3°C\]; measured in an axillary position or temporal is \< 98.4 °F \[36.9°C\]).
* Subject's parent/legal guardian is able to read, understand and complete study questionnaires (i.e., the electronic subject diary device).
* Subject's parent/legal guardian along with the subject is able and is willing to attend all scheduled visits and to comply with the study procedures.
* Subject's parent/legal guardian has access to a telephone.
* Subject's parent/legal guardian agrees not to enroll subject in another interventional study while participating in the present study.
Exclusion Criteria
* Subject has an immune disorder(s) (including autoimmune disease) and/or clinical conditions requiring immunosuppressive drugs, known or suspected impairment of immunological function or a history of congenital or acquired immunodeficiency.
* Subject has or his/her mother has known human immunodeficiency virus infection or known to be hepatitis B surface antigen-positive.
* Subject has functional or anatomic asplenia.
* Subject has known neurological or cognitive behavioral disorders including clinically significant developmental disorder and related disorders.
* 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.
* Subject has any active malignancy or history of malignancy.
* Subject has been in receipt of intramuscular, oral, intravenous, inhaled or intranasal corticosteroid treatment within 2 weeks prior to study vaccination or is planned to receive these medications within 4 weeks after study vaccination. Note: Use of topical corticosteroids is permitted.
* Subject has received any live-attenuated vaccines within 4 weeks prior to receipt of the study vaccine or inactivated vaccines within 2 weeks prior to receipt of study vaccine.
* Subject has previously received an approved (other than PCV13) or investigational pneumococcal vaccine.
* Subject has had any prior receipt of a blood transfusion or blood products, including immunoglobulins.
* Subject has received investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening.
* Subject has received a systemically absorbed antibacterial agent within 7 days prior to study vaccination.
* Subject has a history of microbiologically-proven invasive disease caused by S. pneumoniae.
* Subject has received acetaminophen or nonsteroidal anti-inflammatorydrugs (NSAIDs) within 24 hours prior to receipt of study vaccine.
* Subject has a coagulation disorder.
* Subject's parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study and the subject cannot be adequately followed for safety according to the protocol.
* Subject who has a condition which makes the subject unsuitable for study participation.
* Subject's parent(s)/legal guardian is an employee of Astellas Pharma Global Development Inc., the study-related contract research organizations (CROs), or the study site.
12 Months
15 Months
ALL
Yes
Sponsors
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Affinivax, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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Dermatology Trial Associates
Bryant, Arkansas, United States
The Childrens Clinic
Jonesboro, Arkansas, United States
Emmaus Research Center, Inc
Anaheim, California, United States
Madera Family Medical Group
Madera, California, United States
Ctr Clin Trials San Gabriel
West Covina, California, United States
Gentle Medicine Associates
Boynton Beach, Florida, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Meridian Clinical Research
Baton Rouge, Louisiana, United States
PMG Research
Statesville, North Carolina, United States
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, United States
Pediatrics Medical Associates
East Norriton, Pennsylvania, United States
Coastal Pediatric Associates
Charleston, South Carolina, United States
University of Texas Medical Branch
Galveston, Texas, United States
Houston Clinical Research Associates
Houston, Texas, United States
Tanner Clinic
Layton, Utah, United States
Pediatric Care
Provo, Utah, United States
MultiCare Institute
Spokane, Washington, United States
Countries
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Other Identifiers
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2019-004503-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3772-CL-2001
Identifier Type: -
Identifier Source: org_study_id
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