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.
After screening, participants will be randomized to ASP3772 or PCV13 on Day 1. A single dose of ASP3772 will be administered on Day 1 as an injection into the right or left thigh muscle at one of three dose levels. The participants randomized to PCV13 will receive a single intramuscular injection of the approved dose of PCV13 into the right or left thigh muscle. All participants will remain at the study site for approximately 30 to 60 minutes following vaccination in order for study site personnel to evaluate any immediate reactions, if needed. The participant's parent/legal guardian will observe for reactions, including daily body temperature measurements and tolerability assessments, from Day 2 through Day 7 and record observed events in the electronic diary device. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
75
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
...and 7 more locations
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Up to Day 7
Proportion of Participants Achieving a Serotype-specific Anticapsular Polysaccharide Immunoglobulin G (PS IgG) Concentration of ≥ 0.35 µg/mL for ASP3772
PS IgG concentration measure will be used to characterize the immunological response 30 days following administration of ASP3772.
Time frame: Up to 30 days
Proportion of Participants Achieving a Serotype-specific Anticapsular PS IgG Concentration of ≥ 0.35 µg/mL for PCV13
PS IgG concentration measure will be used to characterize the immunological response 30 days following administration of PCV13.
Time frame: Up to 30 days
Proportion of Participants Achieving a Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer ≥ 1:8 for ASP3772
OPA measure will be used to characterize the immunological response 30 days following administration of ASP3772.
Time frame: Up to 30 days
Proportion of Participants Achieving a Serotype-specific OPA Antibody Titer ≥ 1:8 for PCV13
OPA measure will be used to characterize the immunological response 30 days following administration of PCV13.
Time frame: Up to 30 days
Geometric Mean Titer (GMT) for Serotype-specific OPA for ASP3772
OPA measure will be used to characterize the immunological response 30 days following administration of ASP3772.
Time frame: Up to 30 days
Geometric Mean Titer (GMT) for Serotype-specific OPA for PCV13
OPA measure will be used to characterize the immunological response 30 days following administration of PCV13.
Time frame: Up to 30 days
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