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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004503-12 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1, ASP3772 Low Dose | Experimental | Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a low-dose level. |
|
| Group 1, PCV13 Comparator | Active Comparator | Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1. |
|
| Group 2, ASP3772 Medium Dose | Experimental | Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a medium-dose level. |
|
| Group 2, PCV13 Comparator | Active Comparator | Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1. |
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| Group 3, ASP3772 High Dose | Experimental | Participants will receive a single intramuscular injection of ASP3772 administered on Day 1 at a high-dose level. |
|
| Group 3, PCV13 Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP3772 | Biological | Intramuscular (IM) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 days |
| Proportion of Participants Achieving a Serotype-specific Anticapsular PS IgG Concentration of ≥ 0.35 µg/mL for PCV13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Trial Associates | Bryant | Arkansas | 72022 | United States | ||
| The Childrens Clinic |
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."
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 6, 2023 | |
| Reset | Jan 11, 2024 | |
| Release | Dec 20, 2024 |
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| Active Comparator |
Participants will receive a single intramuscular injection of the approved dose of PCV13 on Day 1. |
|
| PCV13 | Biological | Intramuscular injection |
|
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PS IgG concentration measure will be used to characterize the immunological response 30 days following administration of PCV13. |
| 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. | 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. | 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. | 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. | Up to 30 days |
| 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 |
| Reset | Jan 31, 2025 |
| Release | Apr 14, 2026 |
| Reset | May 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 6, 2023 | Jan 11, 2024 | |||
| Dec 20, 2024 | Jan 31, 2025 | |||
| Apr 14, 2026 | May 1, 2026 |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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