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| ID | Type | Description | Link |
|---|---|---|---|
| 3772-CL-1001 | Other Identifier | Affinivax Inc. Study ID |
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| Name | Class |
|---|---|
| Affinivax, Inc. | INDUSTRY |
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The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in adults 18 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator PCV13 in elderly 65 to 85 years of age. In addition, Stage 2 will evaluate the immunogenicity of 3 different dose levels of ASP3772 relative to the response seen following administration of Pneumovax® 23 (PPSV23) for the serotypes not included in PCV13.
The study population will consist of 3 different groups: Group 1 - Stage 1 PCV13 naïve participants randomized within 3 sequential cohorts to ASP3772 or PCV13; Group 2 - Stage 2 PCV13 naïve participants randomized within 3 sequential cohorts to ASP3772 or PCV13; and Group 3 - Stage 2 participants previously vaccinated with PCV13 that will receive PPSV23.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low dose | Experimental | Healthy adults aged 18 to 64 years received a low dose [1 microgram (μg)] of ASP3772 intramuscularly on Day 1. |
|
| Stage 1, Group 1 Adults, ASP3772 Medium dose | Experimental | Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. |
|
| Stage 1, Group 1 Adults, ASP3772 High dose | Experimental | Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
|
| Stage 1, Group 1, PCV13 Pooled Comparator | Active Comparator | Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 milliliter (mL) intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
|
| Stage 2, Group 2 Older Adults, ASP3772 Low dose | Experimental | Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP3772 | Biological | Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature. | From Day 1, Up to Day 180 |
| Number of Participants With TEAEs, [Stage 2, Group 2] | An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature. As specified in protocol, data was planned to be analyzed for PCV13 pooled comparator from each group given PCV13 to compare with each ASP3772 dose. | From Day 1, Up to Day 180 |
| Number of Participants With TEAEs, [Stage 2, Group 3] | An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | OPA titers were determined for serotypes: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. OPA titer was expressed as the reciprocal of the serum dilution that causes a 50% reduction in the colony-forming units. | At Day 1 and Day 30 |
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Inclusion Criteria:
Stage 1: Subject is healthy male or female between 18 and 64 year of age inclusive, at screening.
Stage 2: Subject is a male or female between 65 and 85 years of age, inclusive, at screening who is healthy or has chronic controlled, stable disease with no change in disease severity, medical therapy and no hospitalization records in last 12 weeks as determined by medical history, physical examination and laboratory data.
A female subject is eligible to participate if not pregnant and at least 1 of the following conditions applies:
Female subject must agree not to breastfeed starting at screening and for 28 days after the study vaccine administration.
Female subject must not donate ova starting at screening and for 28 days after the study vaccine administration.
A male subject with female partner(s) of childbearing potential must agree to use contraception at screening and for at least 28 days after the study vaccine administration.
Male subject must not donate sperm starting at screening and for 90 days after the study vaccine administration.
Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding at screening and for 28 after the study vaccine administration.
Subject agrees not to participate in another interventional study while participating in the present study.
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 |
|---|---|---|---|---|---|---|
| Advanced Clinical Research-Rancho Paseo | Banning | California | 92220 | United States | ||
| Artemis Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38360475 | Derived | Borys D, Rupp R, Smulders R, Chichili GR, Kovanda LL, Santos V, Malinoski F, Siber G, Malley R, Sebastian S. Safety, tolerability and immunogenicity of a novel 24-valent pneumococcal vaccine in toddlers: A phase 1 randomized controlled trial. Vaccine. 2024 Apr 11;42(10):2560-2571. doi: 10.1016/j.vaccine.2024.02.001. Epub 2024 Feb 14. | |
| 35690500 |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Analysis of this study results were reported for the PSV13 Pooled Comparator group to compare with the ASP3772 groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics, Outcome Measures and adverse events reporting were not analyzed for the individual PCV13 groups.
For Stage 1 out Of the 178 participants who provided informed consent only 127 participants were enrolled and randomized into the study.
For Stage 2 Group 2 and Stage 2 Group 3 - out of 757 participants, A total of 390 participants were enrolled and randomized to Group 2 and 113 participants were enrolled in Group 3.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1, Group 1 Adults, ASP3772 Low Dose | Healthy adults aged 18 to 64 years received a low dose [1 microgram (μg)] of ASP3772 intramuscularly on Day 1. |
| FG001 | Stage 1, Group 1 Adults, ASP3772 Medium Dose |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 4, 2019 | Sep 27, 2023 |
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|
| Stage 2, Group 2 Older Adults, ASP3772 Medium dose | Experimental | Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. |
|
| Stage 2, Group 2 Older Adults, ASP3772 High dose | Experimental | Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
|
| Stage 2, Group 2, PCV13 Pooled Comparator | Active Comparator | Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
|
| Stage 2, Group 3, PPSV23 Comparator | Active Comparator | Older adults aged 65 to 85 years who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1. |
|
| PCV13 | Biological | Participants received a single dose of PCV13 intramuscularly. |
|
|
| PPSV23 | Biological | Participants received a single dose of PPSV23 intramuscularly. |
|
|
| From Day 1, Up to Day 30 |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital signs parameters included blood pressure (hypotension and hypertension), pulse rate (tachycardia and bradycardia), body temperature and respiratory rate. Any change in vital sign abnormalities that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition. | During first hour post vaccination (vaccine administered at Day 1) |
| Number of Participants With Potentially Clinically Significant Laboratory Values | Clinical laboratory testing included hematology, clinical chemistry, or urinalysis. Any abnormal laboratory test result (e.g., in hematology, clinical chemistry, or urinalysis) that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Laboratory tests of clinical interest included total bilirubin ≥ 2x ULN and Alkaline phosphatase > 1.5 × upper limit of normal. Study Investigator's interest was to assess only potentially clinically significant values. | Up to Day 30 |
| Number of Participants With Potentially Clinically Significant Physical Examination Values | A physical examination consists of an examination of general appearance, eyes, nose throat, neck (including thyroid), lymph nodes, chest, lungs, cardiovascular, abdomen, skin, extremities, musculoskeletal and neurological system including mental status. Any abnormal test result that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Study Investigator's interest was to assess only potentially clinically significant values. | Up to Day 30 |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management. Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE. Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition. | Day - 28 to Day -1 (28 days prior to study vaccination) |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management. Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE. Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition. | At Day 7 |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 2, Group 3] | The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management. Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE. Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition. | Day - 28 to Day -1 (28 days prior to study vaccination) |
| Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Local reactions include pain, tenderness, redness/erythema, swelling and induration. | Up to 7 Day post Vaccination (vaccine administered at Day 1) |
| Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Assessed solicited local reactions were pain, tenderness, redness/erythema, swelling, induration, itching at injection site and pruritus at injection site. | Up to 7 Day post Vaccination (vaccine administered at Day 1) |
| Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia. | Up to 7 Day post Vaccination (vaccine administered at Day 1) |
| Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia. | Up to 7 Day post Vaccination (vaccine administered at Day 1) |
| Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Immunological responses were assessed in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. | At Day 1 and Day 30 |
| Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Immunological responses were assessed in terms of IgG GMFRs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F. | At Day 30 |
| Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Immunological responses were assessed in terms of percentage of participants with serotype-specific IgG concentration >=4-fold increase. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. | At Day 30 |
| GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. | At Day 30 |
| GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Immunological responses were assessed in terms of OPA GMTs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. | At Day 1 and Day 30 |
| GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Immunological responses were assessed in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. | At Day 1 and Day 30 |
| GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Immunological responses were assessed in terms of IgG GMFRs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F. | At Day 30 |
| Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Immunological responses were assessed in terms of percentage of participants with unique serotypes IgG concentration >=4-fold increase. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. | At Day 30 |
| Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | An analysis of covariance (ANCOVA) model was conducted with age categories (65 to 74 years and 75 to 85 years) serving as covariates, and treatment groups (ASP3772 1 µg, 2 µg, and 5 µg) as the factor of interest. The natural logarithm (log) of pneumococcal OPA titers for each serotype were examined to assess the dose-response relationship. The assessed serotypes were: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,20B, 22F, 23F, and 33F. he assessed serotypes were: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,20B, 22F, 23F, and 33F. | At Day 30 |
| Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | An analysis of covariance (ANCOVA) model was conducted with age categories (65 to 74 years and 75 to 85 years) serving as covariates, and treatment groups (ASP3772 1 µg, 2 µg, and 5 µg) as the factor of interest. The natural logarithm (log) of IgG concentrations for each serotype were examined to assess the dose-response relationship. | At Day 30 |
| GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. | At Day 30 |
| GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Immunogenicity was measured in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. | At Day 30 |
| San Diego |
| California |
| 92103 |
| United States |
| Artemis Institute | San Marcos | California | 92078 | United States |
| Research Centers of America | Hollywood | Florida | 33024 | United States |
| Meridian Clinical Research | Savannah | Georgia | 31406 | United States |
| Sundance Clinical Research | St Louis | Missouri | 63141 | United States |
| Meridian Clinical Research | Norfolk | Nebraska | 68701 | United States |
| United Medical Associates | Binghamton | New York | 13901 | United States |
| PMG Research of Raleigh | Raleigh | North Carolina | 27604 | United States |
| PMG Research of Hickory, LLC | Rocky Mount | North Carolina | 27804 | United States |
| Piedmont HealthCare, PA | Statesville | North Carolina | 28625 | United States |
| Wilmington Health | Wilmington | North Carolina | 28401 | United States |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Tekton Research - George Town | Yukon | Oklahoma | 73099 | United States |
| PMG Research | Knoxville | Tennessee | 37912 | United States |
| PMG Research | Knoxville | Tennessee | 37938 | United States |
| Advanced Clinical Research Institute | Cedar Park | Texas | 78613 | United States |
| Texas Healthcare, PLLC | Fort Worth | Texas | 76104 | United States |
| Benchmark Research | Fort Worth | Texas | 76135 | United States |
| Texas Center for Drug Development | Houston | Texas | 77081 | United States |
| Healthcare Associatiates of Texas | McKinney | Texas | 75070 | United States |
| DM Clinical Research | Pearland | Texas | 77584 | United States |
| Benchmark Research | San Angelo | Texas | 76904 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| CRA of Tidewater Inc | Norfolk | Virginia | 23507 | United States |
| Chichili GR, Smulders R, Santos V, Cywin B, Kovanda L, Van Sant C, Malinoski F, Sebastian S, Siber G, Malley R. Phase 1/2 study of a novel 24-valent pneumococcal vaccine in healthy adults aged 18 to 64 years and in older adults aged 65 to 85 years. Vaccine. 2022 Jul 29;40(31):4190-4198. doi: 10.1016/j.vaccine.2022.05.079. Epub 2022 Jun 9. |
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
| FG002 | Stage 1, Group 1 Adults, ASP3772 High Dose | Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| FG003 | Stage 1, Group 1, PCV13 Pooled Comparator | Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 milliliter (mL) intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| FG004 | Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. |
| FG005 | Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. |
| FG006 | Stage 2, Group 2 Older Adults, ASP3772 High Dose | Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| FG007 | Stage 2, Group 2, PCV13 Pooled Comparator | Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| FG008 | Stage 2, Group 3, PPSV23 Comparator | Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1. |
|
| Vaccinated | Vaccinated = number of participants who completed the vaccination |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1, Group 1 Adults, ASP3772 Low Dose | Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. |
| BG001 | Stage 1, Group 1 Adults, ASP3772 Medium Dose | Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. |
| BG002 | Stage 1, Group 1 Adults, ASP3772 High Dose | Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| BG003 | Stage 1, Group 1, PCV13 Pooled Comparator | Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| BG004 | Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. |
| BG005 | Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. |
| BG006 | Stage 2, Group 2 Older Adults, ASP3772 High Dose | Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| BG007 | Stage 2, Group 2, PCV13 Pooled Comparator | Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| BG008 | Stage 2, Group 3, PPSV23 Comparator | Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature. | The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13. | Posted | Count of Participants | Participants | From Day 1, Up to Day 180 |
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| Primary | Number of Participants With TEAEs, [Stage 2, Group 2] | An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature. As specified in protocol, data was planned to be analyzed for PCV13 pooled comparator from each group given PCV13 to compare with each ASP3772 dose. | The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13. | Posted | Count of Participants | Participants | From Day 1, Up to Day 180 |
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| Primary | Number of Participants With TEAEs, [Stage 2, Group 3] | An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature. | The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with PPSV23. | Posted | Count of Participants | Participants | From Day 1, Up to Day 30 |
|
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| Primary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital signs parameters included blood pressure (hypotension and hypertension), pulse rate (tachycardia and bradycardia), body temperature and respiratory rate. Any change in vital sign abnormalities that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition. | The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13, or PPSV23. | Posted | Count of Participants | Participants | During first hour post vaccination (vaccine administered at Day 1) |
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| Primary | Number of Participants With Potentially Clinically Significant Laboratory Values | Clinical laboratory testing included hematology, clinical chemistry, or urinalysis. Any abnormal laboratory test result (e.g., in hematology, clinical chemistry, or urinalysis) that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Laboratory tests of clinical interest included total bilirubin ≥ 2x ULN and Alkaline phosphatase > 1.5 × upper limit of normal. Study Investigator's interest was to assess only potentially clinically significant values. | The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13, or PPSV23. | Posted | Count of Participants | Participants | Up to Day 30 |
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| Primary | Number of Participants With Potentially Clinically Significant Physical Examination Values | A physical examination consists of an examination of general appearance, eyes, nose throat, neck (including thyroid), lymph nodes, chest, lungs, cardiovascular, abdomen, skin, extremities, musculoskeletal and neurological system including mental status. Any abnormal test result that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Study Investigator's interest was to assess only potentially clinically significant values. | The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13, or PPSV23. | Posted | Count of Participants | Participants | Up to Day 30 |
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| Primary | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management. Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE. Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition. | The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13 and for whom ECG data was available at Day -28 to Day -1. | Posted | Count of Participants | Participants | Day - 28 to Day -1 (28 days prior to study vaccination) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management. Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE. Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition. | The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13 and for whom ECG data was available at Day 7. | Posted | Count of Participants | Participants | At Day 7 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 2, Group 3] | The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management. Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE. Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition. | The analysis was performed on the Safety Analysis Set which consisted of all enrolled participants in Stage 2, Group 3 who received a vaccination in this study with PPSV23 and for whom ECG data was available at Day -28 to Day -1. | Posted | Count of Participants | Participants | Day - 28 to Day -1 (28 days prior to study vaccination) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Local reactions include pain, tenderness, redness/erythema, swelling and induration. | The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13. | Posted | Count of Participants | Participants | Up to 7 Day post Vaccination (vaccine administered at Day 1) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Assessed solicited local reactions were pain, tenderness, redness/erythema, swelling, induration, itching at injection site and pruritus at injection site. | The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PPSV23. | Posted | Count of Participants | Participants | Up to 7 Day post Vaccination (vaccine administered at Day 1) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia. | The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13. | Posted | Count of Participants | Participants | Up to 7 Day post Vaccination (vaccine administered at Day 1) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia. | The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13, or PPSV23. | Posted | Count of Participants | Participants | Up to 7 Day post Vaccination (vaccine administered at Day 1) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | OPA titers were determined for serotypes: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. OPA titer was expressed as the reciprocal of the serum dilution that causes a 50% reduction in the colony-forming units. | The analysis was performed on the Full Analysis Set which consisted of all randomized Participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 and Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Immunological responses were assessed in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. | The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 and Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Immunological responses were assessed in terms of IgG GMFRs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F. | The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 postvaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | At Day 30 |
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| Secondary | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Immunological responses were assessed in terms of percentage of participants with serotype-specific IgG concentration >=4-fold increase. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. | The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. | The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Immunological responses were assessed in terms of OPA GMTs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. | The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 and Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Immunological responses were assessed in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. | The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 and Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Immunological responses were assessed in terms of IgG GMFRs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F. | The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | At Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Immunological responses were assessed in terms of percentage of participants with unique serotypes IgG concentration >=4-fold increase. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. | The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PCV13, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 30 |
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| Secondary | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | An analysis of covariance (ANCOVA) model was conducted with age categories (65 to 74 years and 75 to 85 years) serving as covariates, and treatment groups (ASP3772 1 µg, 2 µg, and 5 µg) as the factor of interest. The natural logarithm (log) of pneumococcal OPA titers for each serotype were examined to assess the dose-response relationship. The assessed serotypes were: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,20B, 22F, 23F, and 33F. he assessed serotypes were: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,20B, 22F, 23F, and 33F. | The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with ASP3772, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Least Squares Mean | 95% Confidence Interval | ln(titers) | At Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | An analysis of covariance (ANCOVA) model was conducted with age categories (65 to 74 years and 75 to 85 years) serving as covariates, and treatment groups (ASP3772 1 µg, 2 µg, and 5 µg) as the factor of interest. The natural logarithm (log) of IgG concentrations for each serotype were examined to assess the dose-response relationship. | The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with ASP3772, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Least Squares Mean | 95% Confidence Interval | ln(titers) | At Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. | The analysis was performed on the Full Analysis Set which consisted of all randomized participants who received a vaccination in this study with either ASP3772 or PPSV23, had at least 1 post vaccination measurement and for whom immunogenicity data was collected for specific serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 30 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Immunogenicity was measured in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. | The analysis was performed on the FAS which consisted of all enrolled participants in Stage 2, Group 3 who received a vaccination in this study with PPSV23 and had at least 1 post vaccination measurement. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 30 |
|
SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23.
Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage 1, Group 1 Adults, ASP3772 Low Dose | Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. | 0 | 30 | 0 | 30 | 22 | 30 |
| EG001 | Stage 1, Group 1 Adults, ASP3772 Medium Dose | Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. | 0 | 31 | 0 | 31 | 24 | 31 |
| EG002 | Stage 1, Group 1 Adults, ASP3772 High Dose | Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. | 0 | 32 | 0 | 32 | 28 | 32 |
| EG003 | Stage 1, Group 1, PCV13 Pooled Comparator | Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). | 0 | 33 | 0 | 33 | 29 | 33 |
| EG004 | Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. | 0 | 100 | 4 | 100 | 56 | 100 |
| EG005 | Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. | 1 | 107 | 5 | 107 | 68 | 107 |
| EG006 | Stage 2, Group 2 Older Adults, ASP3772 High Dose | Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. | 0 | 86 | 1 | 86 | 65 | 86 |
| EG007 | Stage 2, Group 2, PCV13 Pooled Comparator | Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). | 0 | 97 | 0 | 97 | 56 | 97 |
| EG008 | Stage 2, Group 3, PPSV23 Comparator | Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1. | 0 | 113 | 0 | 113 | 4 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Small intestine adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Spinal claudication | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2020 | Sep 27, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018410 | Pneumonia, Bacterial |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
Not provided
Not provided
Not provided
| >=65 to <75 years |
|
| >=75 to <=85 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Vaccine-Related TEAEs |
|
| Medically Attended TEAE |
|
| Potentially Immune Mediated TEAEs |
|
| NOCDs |
|
| Serious TEAEs |
|
| Serious Vaccine-Related TEAE |
|
| Death |
|
Healthy older adults aged 65 to 85 years, received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
| OG002 | Stage 2, Group 2 Older Adults, ASP3772 High Dose | Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| OG003 | Stage 2, Group 2, PCV13 Pooled Comparator | Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
|
|
|
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| OG003 | Stage 1, Group 1, PCV13 Pooled Comparator | Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| OG004 | Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. |
| OG005 | Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1 |
| OG006 | Stage 2, Group 2 Older Adults, ASP3772 High Dose | Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| OG007 | Stage 2, Group 2, PCV13 Pooled Comparator | Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| OG008 | Stage 2, Group 3, PPSV23 Comparator | Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1. |
|
|
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| OG003 | Stage 1, Group 1, PCV13 Pooled Comparator | Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| OG004 | Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. |
| OG005 | Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. |
| OG006 | Stage 2, Group 2 Older Adults, ASP3772 High Dose | Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| OG007 | Stage 2, Group 2, PCV13 Pooled Comparator | Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| OG008 | Stage 2, Group 3, PPSV23 Comparato | Older adults aged 65 to 85 years, who had previously been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1. 113 |
|
|
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| OG003 | Stage 1, Group 1, PCV13 Pooled Comparator | Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| OG004 | Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Healthy older adults aged 65 to 85 years, received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. |
| OG005 | Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. |
| OG006 | Stage 2, Group 2 Older Adults, ASP3772 High Dose | Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| OG007 | Stage 2, Group 2, PCV13 Pooled Comparator | Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| OG008 | Stage 2, Group 3, PPSV23 Comparato | Older adults aged 65 to 85 years, who had previously been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1. 113 |
|
|
| Stage 1, Group 1 Adults, ASP3772 High Dose |
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| OG003 | Stage 1, Group 1, PCV13 Pooled Comparator | Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| OG004 | Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. |
| OG005 | Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. |
| OG006 | Stage 2, Group 2 Older Adults, ASP3772 High Dose | Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| OG007 | Stage 2, Group 2, PCV13 Pooled Comparator | Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
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Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| OG003 | Stage 1, Group 1, PCV13 Pooled Comparator | Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| OG004 | Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. |
| OG005 | Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. |
| OG006 | Stage 2, Group 2 Older Adults, ASP3772 High Dose | Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| OG007 | Stage 2, Group 2, PCV13 Pooled Comparator | Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
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|
Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
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| Stage 2, Group 2, PCV13 Pooled Comparator |
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| OG004 | Stage 2, Group 3, PPSV23 Comparator | Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1. |
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|
Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
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|
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
| OG004 | Stage 2, Group 3, PPSV23 Comparator | Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1. |
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| OG003 | Stage 1, Group 1, PCV13 Pooled Comparator | Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
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| OG003 |
| Stage 1, Group 1, PCV13 Pooled Comparator |
Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
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|
| Stage 1, Group 1, PCV13 Pooled Comparator |
Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
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|
| OG003 | Stage 1, Group 1, PCV13 Pooled Comparator | Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
|
|
Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
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|
| OG003 |
| Stage 2, Group 2, PCV13 Pooled Comparator |
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
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|
| Stage 2, Group 2, PCV13 Pooled Comparator |
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
|
|
|
| Stage 2, Group 2, PCV13 Pooled Comparator |
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
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|
| OG003 | Stage 2, Group 2, PCV13 Pooled Comparator | Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose). |
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| OG002 |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose |
Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
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| Stage 2, Group 3, PPSV23 Comparator |
Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1. |
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Older adults aged 65 to 85 years, who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1. |
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