The purpose of this study is to evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly to Japanese healthy adults 20 to 49 years of age. This study will also evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly, in comparison to the active comparator 23-valent pneumococcal polysaccharide vaccine (PPSV23) in Japanese elderly subjects 65 to 85 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
126
Subcutaneous injection
Intramuscular injection
Subcutaneous injection
Intramuscular injection
JP81001
Fukuoka, Japan
Percentage of participants with 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)
An adverse event (AE) is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. TEAE is defined as an AE occurring after study immunization to the last visit (up to 30 days post-vaccination if the study is discontinued for an individual subject). An IP-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator or subinvestigator.
Time frame: Up to Day 30
Percentage of participants with vital sign abnormalities and/or adverse events (AEs)
Percentage of participants with potentially clinically significant vital sign values.
Time frame: Up to Day 30
Percentage of participants reporting solicited local adverse reactions
Local reactions include pain, tenderness, erythema/redness, swelling, and induration. The reaction will be graded with 4-range grade: 1 (mild) to 4 (potentially life-threatening).
Time frame: Up to Day 7
Percentage of participants reporting solicited systemic adverse reactions
Systemic reactions include nausea, vomiting, diarrhea, headache, fever, fatigue and myalgia and arthralgia. Vital signs up to 7 days postvaccination are collected as systemic reactions. The reaction will be graded with 4-range grade: 1 (mild) to 4 (potentially life-threatening).
Time frame: Up to Day 7
Percentage of participants with laboratory value abnormalities and/or adverse events (AEs)
Percentage of participants with potentially clinically significant laboratory values.
Time frame: Up to Day 30
Percentage of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Percentage of participants with potentially clinically significant ECG values.
Time frame: Up to Day 30
Percentage of participants with physical exam abnormalities and/or adverse events (AEs)
Percentage of participants with potentially clinically significant physical exam values.
Time frame: Up to Day 30
Geometric mean titer (GMT) for opsonophagocytic activity (OPA) for each serotype contained in ASP3772
OPA measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Time frame: On Day 30
GMT for OPA for each serotype contained in PPSV23
OPA measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Time frame: On Day 30
Ratio of the OPA GMT (each ASP3772 dose level/PPSV23)
OPA measure will be used to characterize the immunological response on Day 30 after administration of ASP3772 and PPSV23
Time frame: On Day 30
Geometric mean concentration (GMC) for pneumococcal serotype-specific anticapsular polysaccharide immunoglobulin G (PS IgG) for each serotype contained in ASP3772
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Time frame: On Day 30
GMC for pneumococcal serotype-specific anticapsular PS IgG for each serotype contained in PPSV23
PS IgG measure measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Time frame: On Day 30
Ratio of GMC for pneumococcal serotype-specific anticapsular PS IgG (each ASP3772 dose level/PPSV23)
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772 and PPSV23.
Time frame: On Day 30
Geometric mean fold rise (GMFR) in anticapsular PS IgG concentration on day 30 relative to pre-immunization contained in ASP3772
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: On Day 30
GMFR in anticapsular PS IgG concentration on day 30 relative to pre-immunization contained in PPSV23
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Time frame: On Day 30
GMFR in OPA titer on day 30 relative to pre-immunization contained in ASP3772
OPA titer will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Time frame: On Day 30
GMFR in OPA titer on day 30 relative to pre-immunization contained in PPSV23
OPA titer will be used to characterize the immunological response on Day 30 after administration of PPSV23
Time frame: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in pneumococcal serotype-specific anticapsular PS IgG concentration for each serotype contained in ASP3772
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Time frame: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in pneumococcal serotype-specific anticapsular PS IgG concentration for each serotype contained in PPSV23
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Time frame: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in OPA titer for each serotype contained in ASP3772
OPA titer will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Time frame: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in OPA titer for each serotype contained in PPSV23
OPA titer will be used to characterize the immunological response on Day 30 after administration of PPSV23
Time frame: On Day 30