Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP3772 (subcutaneous) in Adults | Experimental | Participants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels. |
|
| ASP3772 ((intramuscular) in Adults | Experimental | Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels. |
|
| ASP3772 (subcutaneous) in Elderly | Experimental | Participants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels. |
|
| ASP3772 (intramuscular) in Elderly | Experimental | Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels |
|
| PPSV23 (subcutaneous) in Elderly | Active Comparator | Participants will receive a single subcutaneous injection of the standard dose of PPSV23 on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP3772 (subcutaneous) | Biological | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | On Day 30 |
| GMT for OPA for each serotype contained in PPSV23 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JP81001 | Fukuoka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39612802 | Derived | Borys D, Smulders R, Haranaka M, Nakano T, Chichili GR, Ebara M, Hashimoto A, Iwahana M, Oizumi Y, Nanra J, Malley R, Sebastian S. Safety, reactogenicity, and immunogenicity of a novel 24-valent pneumococcal vaccine candidate in healthy, pneumococcal vaccine-naive Japanese adults: A phase 1 randomized dose-escalation trial. Vaccine. 2025 Jan 12;44:126545. doi: 10.1016/j.vaccine.2024.126545. Epub 2024 Nov 29. |
Not provided
Not provided
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."
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PPSV23 (intramuscular) in Elderly | Active Comparator | Participants will receive a single intramuscular injection of the standard dose of PPSV23 on Day 1. |
|
| ASP3772 (intramuscular) | Biological | Intramuscular injection |
|
| PPSV23 (subcutaneous) | Biological | Subcutaneous injection |
|
|
| PPSV23 (intramuscular) | Biological | Intramuscular injection |
|
|
| 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. | 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. | Up to Day 30 |
OPA measure will be used to characterize the immunological response on Day 30 after administration of PPSV23 |
| 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 | 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. | 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 | 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. | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | On Day 30 |
| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| D007273 | Injections, Intramuscular |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided