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
A Phase 1, Randomized, Single Dose, Blinded, Dose-Escalation Study to Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator
2 other identifiers
interventional
75
1 country
17
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of three dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in toddlers who have previously been administered the routine three-dose series of PCV13. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Sep 2020
Longer than P75 for phase_1 healthy-volunteers
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedStudy Start
First participant enrolled
September 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2022
CompletedJune 6, 2022
June 1, 2022
1.5 years
August 21, 2020
June 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE is defined as an adverse event (AE) observed after study vaccination and up to 30 days post-vaccination. A vaccine-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator.
Up to Day 30
Number of Participants With Body Temperature Abnormalities and/or Adverse Events
Number of participants with potentially clinically significant body temperature abnormalities.
Up to Day 30
Reactogenicity Assessed by Number of Solicited Local Reactions
Local reactions are tenderness, movement restriction, redness/erythema and swelling and induration. Local reactogenicity will be evaluated at approximately 30 to 60 minutes post-dose by study site personnel and recorded in an electronic diary device by the participant's parent/legal guardian while at the study site on day 1. The participant's parent/legal guardian will observe reactogenicity and tolerability from day 2 through day 7, and record observed events daily in the electronic diary device. Grades range from 1 (mild) to 4 (potentially life-threatening).
Up to Day 7
Reactogenicity assessed by Number of Solicited Systemic Reactions
Systemic reactions are vomiting, diarrhea, fever, irritability, decrease of appetite and increase or decrease in sleep. Body temperature will be assessed pre-dose and approximately 30 to 60 minutes post-dose. The participant's parent/legal guardian will be asked to observe the systemic reactogenicity symptoms from day 2 through day 7 and record observed events daily in the electronic diary device. Grades range from 1 (mild) to 4 (potentially life-threatening).
Up to Day 7
Secondary Outcomes (6)
Proportion of Participants Achieving a Serotype-specific Anticapsular Polysaccharide Immunoglobulin G (PS IgG) Concentration of ≥ 0.35 µg/mL for ASP3772
Up to 30 days
Proportion of Participants Achieving a Serotype-specific Anticapsular PS IgG Concentration of ≥ 0.35 µg/mL for PCV13
Up to 30 days
Proportion of Participants Achieving a Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer ≥ 1:8 for ASP3772
Up to 30 days
Proportion of Participants Achieving a Serotype-specific OPA Antibody Titer ≥ 1:8 for PCV13
Up to 30 days
Geometric Mean Titer (GMT) for Serotype-specific OPA for ASP3772
Up to 30 days
- +1 more secondary outcomes
Study Arms (6)
Group 1, ASP3772 Low Dose
EXPERIMENTALParticipants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a low-dose level.
Group 1, PCV13 Comparator
ACTIVE COMPARATORParticipants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.
Group 2, ASP3772 Medium Dose
EXPERIMENTALParticipants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a medium-dose level.
Group 2, PCV13 Comparator
ACTIVE COMPARATORParticipants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.
Group 3, ASP3772 High Dose
EXPERIMENTALParticipants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a high-dose level.
Group 3, PCV13 Comparator
ACTIVE COMPARATORParticipants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- Subject is a healthy toddler who has previously completed a 3-dose infant series of PCV13 with the last vaccination greater than 2 months prior to study vaccination.
- 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.
You may not qualify if:
- Subject has a known hypersensitivity to any vaccine.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Affinivax, Inc.lead
Study Sites (17)
Dermatology Trial Associates
Bryant, Arkansas, 72022, United States
The Childrens Clinic
Jonesboro, Arkansas, 72401, United States
Emmaus Research Center, Inc
Anaheim, California, 92804, United States
Madera Family Medical Group
Madera, California, 93637, United States
Ctr Clin Trials San Gabriel
West Covina, California, 91790, United States
Gentle Medicine Associates
Boynton Beach, Florida, 33435, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
Meridian Clinical Research
Baton Rouge, Louisiana, 70806, United States
PMG Research
Statesville, North Carolina, 28625, United States
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, 74127, United States
Pediatrics Medical Associates
East Norriton, Pennsylvania, 19401, United States
Coastal Pediatric Associates
Charleston, South Carolina, 29414, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Houston Clinical Research Associates
Houston, Texas, 77090, United States
Tanner Clinic
Layton, Utah, 84041, United States
Pediatric Care
Provo, Utah, 84604, United States
MultiCare Institute
Spokane, Washington, 99202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
August 25, 2020
Study Start
September 22, 2020
Primary Completion
April 6, 2022
Study Completion
April 6, 2022
Last Updated
June 6, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."