Pneumonia, Bacterial, Healthy Volunteers, Pneumococcal Disease
Conditions
Keywords
Pneumococcal vaccine, Vaccine, Pneumococccal Disease, ASP3772
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Affinivax, Inc.
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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: * Not a woman of childbearing potential (WOCBP) OR * WOCBP who agrees to follow the contraceptive guidance at screening and for at least 28 days after the study vaccine administration. * 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
* Subject has a known or suspected hypersensitivity to ASP3772, its comparators or any components of the formulations used. * Subject has had previous exposure with ASP3772. * Subject has had known previous exposure with PPSV23. * Subject has received PCV13 or any other licensed or investigational pneumococcal vaccine at any time. (Note: This exclusion criterion is not applicable to Group 3; those subjects 65 to 85 years of age who previously received immunization with PCV13. Prior PCV13 immunization should have taken place no less than 10 months and no more than 2 years prior to study vaccine administration. These subjects are eligible to be enrolled in the nonrandomized arm of Stage 2, Group 3. * Subject has a history of microbiologically-proven invasive disease caused by S. pneumoniae. * Subject has an immune disorder(s) (including autoimmune disease) and/or clinical conditions requiring immunosuppressive drugs. * Subject has any evidence of any unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, e.g., uncontrolled hypertension, uncontrolled diabetes, heart failure, uncontrolled chronic obstructive pulmonary disease, end-stage renal disease. * Subject has history of illicit drug(s) or alcohol abuse that will interfere with the protocol requirements and/or a positive urine drug test (for Stage 1 subjects only) at screening. * Subject has any clinically significant history of allergic conditions including drug allergies, asthma or anaphylactic reactions, but excluding untreated asymptomatic seasonal allergies prior to study vaccine administration. * Subject has a coagulation disorder contraindicating intramuscular immunization. * Subject has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies (anti-HCV) confirmed by reflex testing (HCV-RNA) or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening. * Subject has/had febrile illness (\> 100.4°F oral equivalent) or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day 1. * Subject has any clinically significant abnormality from the physical examination, ECG and clinical laboratory tests during screening. * Subject is unlikely to adhere to study procedures, keep appointments, is planning to relocate during the study or cannot be adequately followed for safety according to the protocol. * Subject has any other condition, which precludes the subject's participation in the study. * Subject has received any vaccines within 30 days prior of receipt of the study vaccine (exception: Influenza virus vaccine given according to recommended guidelines must be given at least 7 days prior to receiving study vaccine). * Subject has had significant blood loss, donated 1 unit (450 mL or more) or received transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to day 1. * Subject has received any systemically absorbed antibiotics during the 7-day period prior to day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | From Day 1, Up to Day 180 | 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. |
| Number of Participants With TEAEs, [Stage 2, Group 2] | From Day 1, Up to Day 180 | 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. |
| Number of Participants With TEAEs, [Stage 2, Group 3] | From Day 1, Up to Day 30 | 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. |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | During first hour post vaccination (vaccine administered at Day 1) | 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. |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 2, Group 3] | Day - 28 to Day -1 (28 days prior to study vaccination) | 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. |
| Number of Participants With Potentially Clinically Significant Laboratory Values | Up to Day 30 | 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. |
| Number of Participants With Potentially Clinically Significant Physical Examination Values | Up to Day 30 | 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. |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | Day - 28 to Day -1 (28 days prior to study vaccination) | 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. |
| Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Up to 7 Day post Vaccination (vaccine administered at Day 1) | Local reactions include pain, tenderness, redness/erythema, swelling and induration. |
| Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Up to 7 Day post Vaccination (vaccine administered at Day 1) | Assessed solicited local reactions were pain, tenderness, redness/erythema, swelling, induration, itching at injection site and pruritus at injection site. |
| Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Up to 7 Day post Vaccination (vaccine administered at Day 1) | Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia. |
| Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Up to 7 Day post Vaccination (vaccine administered at Day 1) | Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | At Day 1 and Day 30 | 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. |
| GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | At Day 30 | 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. |
| Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | At Day 1 and Day 30 | 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. |
| Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | At Day 30 | 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. |
| Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | At Day 30 | 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. |
| GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | At Day 30 | Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. |
| GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | At Day 1 and Day 30 | 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. |
| GMCs for Serotype-specific IgG, [Stage 2, Group 2] | At Day 1 and Day 30 | 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. |
| GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | At Day 30 | 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. |
| Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | At Day 30 | 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. |
| Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | At Day 30 | 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. |
| Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | At Day 30 | 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. |
| GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | At Day 30 | Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 32 |
| 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. | 32 |
| 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). | 33 |
| 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. | 100 |
| 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. | 107 |
| 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. | 86 |
| 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). | 97 |
| 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. | 113 |
| Total | 630 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Other | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Stage 1, Group 1 Adults, ASP3772 Medium Dose | Stage 1, Group 1 Adults, ASP3772 High Dose | Stage 1, Group 1, PCV13 Pooled Comparator | Stage 1, Group 1 Adults, ASP3772 Low Dose | Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Stage 2, Group 2 Older Adults, ASP3772 High Dose | Stage 2, Group 2, PCV13 Pooled Comparator | Stage 2, Group 3, PPSV23 Comparator | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized >=18 to <65 years | 32 Participants | 32 Participants | 33 Participants | 30 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 127 Participants |
| Age, Customized >=65 to <75 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 90 Participants | 89 Participants | 78 Participants | 84 Participants | 108 Participants | 449 Participants |
| Age, Customized >=75 to <=85 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants | 18 Participants | 8 Participants | 13 Participants | 5 Participants | 54 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 2 Participants | 5 Participants | 4 Participants | 10 Participants | 15 Participants | 7 Participants | 16 Participants | 7 Participants | 71 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 26 Participants | 29 Participants | 28 Participants | 25 Participants | 89 Participants | 92 Participants | 79 Participants | 78 Participants | 104 Participants | 550 Participants |
| Sex: Female, Male Female | 21 Participants | 21 Participants | 23 Participants | 19 Participants | 64 Participants | 55 Participants | 44 Participants | 52 Participants | 70 Participants | 369 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 10 Participants | 11 Participants | 36 Participants | 52 Participants | 42 Participants | 45 Participants | 43 Participants | 261 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 31 | 0 / 32 | 0 / 33 | 0 / 100 | 1 / 107 | 0 / 86 | 0 / 97 | 0 / 113 |
| other Total, other adverse events | 22 / 30 | 24 / 31 | 28 / 32 | 29 / 33 | 56 / 100 | 68 / 107 | 65 / 86 | 56 / 97 | 4 / 113 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 | 0 / 32 | 0 / 33 | 4 / 100 | 5 / 107 | 1 / 86 | 0 / 97 | 0 / 113 |
Outcome results
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.
Time frame: Day - 28 to Day -1 (28 days prior to study vaccination)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
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.
Time frame: At Day 7
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 1 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 1 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2] | 0 Participants |
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.
Time frame: Day - 28 to Day -1 (28 days prior to study vaccination)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 2, Group 3] | 0 Participants |
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.
Time frame: During first hour post vaccination (vaccine administered at Day 1)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (diastolic) | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Respiratory Rate | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Tachycardia | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Temperature Increase | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (systolic) | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Bradycardia | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypotension (systolic) | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (systolic) | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Temperature Increase | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Respiratory Rate | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Tachycardia | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypotension (systolic) | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Bradycardia | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (diastolic) | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Respiratory Rate | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypotension (systolic) | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (systolic) | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (diastolic) | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Tachycardia | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Bradycardia | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Temperature Increase | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Bradycardia | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Respiratory Rate | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (systolic) | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypotension (systolic) | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Temperature Increase | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (diastolic) | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Tachycardia | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (systolic) | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Temperature Increase | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Tachycardia | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Bradycardia | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (diastolic) | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypotension (systolic) | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Respiratory Rate | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Tachycardia | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypotension (systolic) | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Bradycardia | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (diastolic) | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Respiratory Rate | 1 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Temperature Increase | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (systolic) | 1 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Tachycardia | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (diastolic) | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypotension (systolic) | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Bradycardia | 1 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Temperature Increase | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (systolic) | 1 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Respiratory Rate | 2 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Respiratory Rate | 3 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Bradycardia | 0 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Tachycardia | 0 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (systolic) | 2 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypotension (systolic) | 0 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Temperature Increase | 0 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (diastolic) | 1 Participants |
| Stage 2, Group 3, PPSV23 Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypotension (systolic) | 0 Participants |
| Stage 2, Group 3, PPSV23 Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Tachycardia | 0 Participants |
| Stage 2, Group 3, PPSV23 Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Respiratory Rate | 0 Participants |
| Stage 2, Group 3, PPSV23 Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (diastolic) | 0 Participants |
| Stage 2, Group 3, PPSV23 Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Bradycardia | 0 Participants |
| Stage 2, Group 3, PPSV23 Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Temperature Increase | 0 Participants |
| Stage 2, Group 3, PPSV23 Comparator | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Hypertension (systolic) | 0 Participants |
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.
Time frame: Up to Day 30
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Total Bilirubin | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Total Bilirubin | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Total Bilirubin | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Potentially Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Potentially Clinically Significant Laboratory Values | Total Bilirubin | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Total Bilirubin | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Total Bilirubin | 1 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Potentially Clinically Significant Laboratory Values | Total Bilirubin | 0 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Potentially Clinically Significant Laboratory Values | Total Bilirubin | 0 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Potentially Clinically Significant Laboratory Values | Alkaline phosphatase | 1 Participants |
| Stage 2, Group 3, PPSV23 Comparator | Number of Participants With Potentially Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| Stage 2, Group 3, PPSV23 Comparator | Number of Participants With Potentially Clinically Significant Laboratory Values | Total Bilirubin | 0 Participants |
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.
Time frame: Up to Day 30
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Potentially Clinically Significant Physical Examination Values | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Potentially Clinically Significant Physical Examination Values | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Potentially Clinically Significant Physical Examination Values | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Potentially Clinically Significant Physical Examination Values | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Number of Participants With Potentially Clinically Significant Physical Examination Values | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Medium Dose | Number of Participants With Potentially Clinically Significant Physical Examination Values | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 High Dose | Number of Participants With Potentially Clinically Significant Physical Examination Values | 0 Participants |
| Stage 2, Group 2, PCV13 Pooled Comparator | Number of Participants With Potentially Clinically Significant Physical Examination Values | 0 Participants |
| Stage 2, Group 3, PPSV23 Comparator | Number of Participants With Potentially Clinically Significant Physical Examination Values | 0 Participants |
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.
Time frame: From Day 1, Up to Day 180
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Serious TEAEs | 4 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Medically Attended TEAE | 7 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Death | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | TEAE | 25 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | New Onset Chronic TEAEs | 2 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Serious Vaccine-Related TEAE | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Vaccine-Related TEAEs | 5 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Potentially Immune Mediated TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Vaccine-Related TEAEs | 5 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Serious Vaccine-Related TEAE | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Death | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | TEAE | 26 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Medically Attended TEAE | 9 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | New Onset Chronic TEAEs | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Potentially Immune Mediated TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Serious TEAEs | 5 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Medically Attended TEAE | 7 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Serious TEAEs | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Potentially Immune Mediated TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Death | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Vaccine-Related TEAEs | 8 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | TEAE | 28 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | Serious Vaccine-Related TEAE | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With TEAEs, [Stage 2, Group 2] | New Onset Chronic TEAEs | 1 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With TEAEs, [Stage 2, Group 2] | Death | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With TEAEs, [Stage 2, Group 2] | TEAE | 14 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With TEAEs, [Stage 2, Group 2] | Vaccine-Related TEAEs | 3 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With TEAEs, [Stage 2, Group 2] | Medically Attended TEAE | 3 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With TEAEs, [Stage 2, Group 2] | New Onset Chronic TEAEs | 1 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With TEAEs, [Stage 2, Group 2] | Potentially Immune Mediated TEAEs | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With TEAEs, [Stage 2, Group 2] | Serious TEAEs | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With TEAEs, [Stage 2, Group 2] | Serious Vaccine-Related TEAE | 0 Participants |
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.
Time frame: From Day 1, Up to Day 30
Population: The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with PPSV23.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 3] | Medically Attended TEAE | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 3] | TEAE | 12 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 3] | Vaccine-Related TEAEs | 2 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 3] | New Onset Chronic TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 3] | Potentially Immune Mediated TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 3] | Serious TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 3] | Serious Vaccine-Related TEAE | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With TEAEs, [Stage 2, Group 3] | Death | 0 Participants |
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.
Time frame: From Day 1, Up to Day 180
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | TEAE | 11 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | NOCDs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Vaccine-Related TEAEs | 2 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Serious TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Medically Attended TEAE | 3 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Death | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Potentially Immune Mediated TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Serious Vaccine-Related TEAE | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | TEAE | 5 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Potentially Immune Mediated TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | NOCDs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Death | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Medically Attended TEAE | 3 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Serious Vaccine-Related TEAE | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Serious TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Vaccine-Related TEAEs | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Serious TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Serious Vaccine-Related TEAE | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Vaccine-Related TEAEs | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Death | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Medically Attended TEAE | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | TEAE | 5 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Potentially Immune Mediated TEAEs | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | NOCDs | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Death | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | TEAE | 5 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Vaccine-Related TEAEs | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Medically Attended TEAE | 1 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Potentially Immune Mediated TEAEs | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | NOCDs | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Serious TEAEs | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] | Serious Vaccine-Related TEAE | 0 Participants |
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.
Time frame: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Erythema/Redness | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Pain | 16 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Swelling | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Induration | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Tenderness | 15 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Induration | 2 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Erythema/Redness | 2 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Swelling | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Pain | 19 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Tenderness | 22 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Induration | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Tenderness | 20 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Pain | 20 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Erythema/Redness | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Swelling | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Erythema/Redness | 3 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Pain | 24 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Tenderness | 25 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Induration | 4 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1] | Swelling | 3 Participants |
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.
Time frame: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Tenderness | 38 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Other Illness/Clinical Event-Pruritus At Injection Site | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Other Illness/Clinical Event-Itching At Injection Site | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Induration | 2 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Pain | 26 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Erythema/Redness | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Swelling | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Swelling | 6 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Erythema/Redness | 4 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Pain | 37 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Tenderness | 51 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Other Illness/Clinical Event-Itching At Injection Site | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Induration | 6 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Other Illness/Clinical Event-Pruritus At Injection Site | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Erythema/Redness | 5 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Tenderness | 48 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Pain | 38 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Induration | 4 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Swelling | 3 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Other Illness/Clinical Event-Itching At Injection Site | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Other Illness/Clinical Event-Pruritus At Injection Site | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Induration | 2 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Swelling | 4 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Pain | 33 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Other Illness/Clinical Event-Pruritus At Injection Site | 1 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Other Illness/Clinical Event-Itching At Injection Site | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Tenderness | 42 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Erythema/Redness | 4 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Induration | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Other Illness/Clinical Event-Pruritus At Injection Site | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Other Illness/Clinical Event-Itching At Injection Site | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Swelling | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Pain | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Tenderness | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3] | Erythema/Redness | 0 Participants |
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.
Time frame: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Headache | 5 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Nausea | 3 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Fever | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Diarrhea | 4 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Fatigue | 7 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Vomiting | 0 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Myalgia | 7 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Myalgia | 7 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Headache | 6 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Fever | 3 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Nausea | 5 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Diarrhea | 2 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Vomiting | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Fatigue | 8 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Fever | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Vomiting | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Myalgia | 11 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Fatigue | 10 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Headache | 7 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Diarrhea | 4 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Nausea | 2 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Headache | 13 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Fatigue | 13 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Fever | 0 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Nausea | 3 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Myalgia | 13 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Vomiting | 1 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1] | Diarrhea | 6 Participants |
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.
Time frame: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Vomiting | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Arthralgia | 5 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Diarrhea | 3 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Nausea | 4 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Headache | 13 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Fatigue | 18 Participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Myalgia | 11 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Nausea | 9 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Myalgia | 26 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Fatigue | 18 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Diarrhea | 15 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Arthralgia | 10 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Vomiting | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Headache | 12 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Fatigue | 22 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Vomiting | 1 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Headache | 10 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Myalgia | 27 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Arthralgia | 13 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Nausea | 2 Participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Diarrhea | 13 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Nausea | 6 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Arthralgia | 8 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Vomiting | 2 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Diarrhea | 6 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Headache | 10 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Fatigue | 21 Participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Myalgia | 17 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Vomiting | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Myalgia | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Diarrhea | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Arthralgia | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Nausea | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Headache | 0 Participants |
| Stage 2, Group 2 Older Adults, ASP3772 Low Dose | Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3] | Fatigue | 0 Participants |
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.
Time frame: At Day 30
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 9V, Day 30 | 7.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 33F, Day 30 | 8.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 19A, Day 30 | 7.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 10A, Day 30 | 7.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 1, Day 30 | 5.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 14, Day 30 | 7.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 11A, Day 30 | 5.8 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 5, Day 30 | 6.1 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 7F, Day 30 | 7.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 12F, Day 30 | 7.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 3, Day 30 | 5.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 6A, Day 30 | 7.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 20B, Day 30 | 9.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 15B, Day 30 | 8.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 2, Day 30 | 7.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 19F, Day 30 | 7.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 6B, Day 30 | 7.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 18C, Day 30 | 6.9 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 23F, Day 30 | 6.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 17F, Day 30 | 8.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 8, Day 30 | 7.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 9N, Day 30 | 7.8 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 4, Day 30 | 6.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 22F, Day 30 | 7.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 20B, Day 30 | 9.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 1, Day 30 | 5.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 2, Day 30 | 6.9 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 3, Day 30 | 6.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 4, Day 30 | 6.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 5, Day 30 | 6.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 6A, Day 30 | 7.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 7F, Day 30 | 7.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 9N, Day 30 | 8.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 9V, Day 30 | 7.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 10A, Day 30 | 7.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 11A, Day 30 | 6.1 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 12F, Day 30 | 6.8 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 14, Day 30 | 7.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 15B, Day 30 | 8.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 6B, Day 30 | 7.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 8, Day 30 | 7.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 17F, Day 30 | 7.9 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 18C, Day 30 | 7.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 19A, Day 30 | 7.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 19F, Day 30 | 7.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 22F, Day 30 | 7.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 23F, Day 30 | 6.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 33F, Day 30 | 8.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 17F, Day 30 | 8.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 9V, Day 30 | 7.8 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 9N, Day 30 | 8.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 7F, Day 30 | 7.9 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 22F, Day 30 | 7.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 6B, Day 30 | 7.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 3, Day 30 | 6.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 18C, Day 30 | 7.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 33F, Day 30 | 8.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 19A, Day 30 | 7.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 6A, Day 30 | 7.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 23F, Day 30 | 6.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 19F, Day 30 | 7.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 5, Day 30 | 6.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 14, Day 30 | 7.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 4, Day 30 | 6.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 15B, Day 30 | 8.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 2, Day 30 | 7.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 12F, Day 30 | 7.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 20B, Day 30 | 9.8 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 11A, Day 30 | 6.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 1, Day 30 | 5.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 8, Day 30 | 7.8 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2) | Serotype 10A, Day 30 | 7.8 ln(titers) |
Comparison: Serotype 1, Day 30p-value: 0.80595% CI: [-0.4, 0.5]ANCOVA
Comparison: Serotype 1, Day 30p-value: 0.10295% CI: [-0.1, 0.9]ANCOVA
Comparison: Serotype 1, Day 30p-value: 0.15895% CI: [-0.1, 0.9]ANCOVA
Comparison: Serotype 2, Day 30p-value: 0.59695% CI: [-0.4, 0.2]ANCOVA
Comparison: Serotype 2, Day 30p-value: 0.02595% CI: [0, 0.7]ANCOVA
Comparison: Serotype 2, Day 30p-value: 0.00595% CI: [0.1, 0.7]ANCOVA
Comparison: Serotype 3, Day 30p-value: 0.03795% CI: [0, 0.7]ANCOVA
Comparison: Serotype 3, Day 30p-value: 0.00295% CI: [0.2, 0.9]ANCOVA
Comparison: Serotype 3, Day 30p-value: 0.2395% CI: [-0.1, 0.6]ANCOVA
Comparison: Serotype 4, Day 30p-value: 0.98495% CI: [-0.4, 0.4]ANCOVA
Comparison: Serotype 4, Day 30p-value: 0.26295% CI: [-0.2, 0.6]ANCOVA
Comparison: Serotype 4, Day 30p-value: 0.26495% CI: [-0.2, 0.6]ANCOVA
Comparison: Serotype 5, Day 30p-value: 0.63895% CI: [-0.4, 0.6]ANCOVA
Comparison: Serotype 5, Day 30p-value: 0.03695% CI: [0, 1]ANCOVA
Comparison: Serotype 5, Day 30p-value: 0.09495% CI: [-0.1, 0.9]ANCOVA
Comparison: Serotype 6A, Day 30p-value: 0.26695% CI: [-0.2, 0.8]ANCOVA
Comparison: Serotype 6A, Day 30p-value: 0.2595% CI: [-0.2, 0.8]ANCOVA
Comparison: Serotype 6A, Day 30p-value: 0.92795% CI: [-0.5, 0.5]ANCOVA
Comparison: Serotype 6B, Day 30p-value: 0.67995% CI: [-0.5, 0.3]ANCOVA
Comparison: Serotype 6B, Day 30p-value: 0.58995% CI: [-0.6, 0.3]ANCOVA
Comparison: Serotype 6B, Day 30p-value: 0.8895% CI: [-0.5, 0.4]ANCOVA
Comparison: Serotype 7F, Day 30p-value: 0.62395% CI: [-0.2, 0.4]ANCOVA
Comparison: Serotype 7F, Day 30p-value: 0.23295% CI: [-0.1, 0.6]ANCOVA
Comparison: Serotype 7F, Day 30p-value: 0.45195% CI: [-0.2, 0.5]ANCOVA
Comparison: Serotype 8, Day 30p-value: 0.78595% CI: [-0.3, 0.4]ANCOVA
Comparison: Serotype 8, Day 30p-value: <0.00195% CI: [0.4, 1.1]ANCOVA
Comparison: Serotype 8, Day 30p-value: <0.00195% CI: [0.4, 1.1]ANCOVA
Comparison: Serotype 9N, Day 30p-value: 0.14695% CI: [-0.1, 0.5]ANCOVA
Comparison: Serotype 9N, Day 30p-value: 0.00395% CI: [0.2, 0.8]ANCOVA
Comparison: Serotype 9N, Day 30p-value: 0.11395% CI: [-0.1, 0.6]ANCOVA
Comparison: Serotype 9V, Day 30p-value: 0.45395% CI: [-0.6, 0.3]ANCOVA
Comparison: Serotype 9V, Day 30p-value: 0.11195% CI: [-0.1, 0.8]ANCOVA
Comparison: Serotype 9V, Day 30p-value: 0.0295% CI: [0.1, 1]ANCOVA
Comparison: Serotype 10A, Day 30p-value: 0.21895% CI: [-0.2, 0.8]ANCOVA
Comparison: Serotype 10A, Day 30p-value: 0.12595% CI: [-0.1, 0.9]ANCOVA
Comparison: Serotype 10A, Day 30p-value: 0.70695% CI: [-0.4, 0.6]ANCOVA
Comparison: Serotype 11A, Day 30p-value: 0.24695% CI: [-0.1, 0.6]ANCOVA
Comparison: Serotype 11A, Day 30p-value: <0.00195% CI: [0.3, 1.1]ANCOVA
Comparison: Serotype 11A, Day 30p-value: 0.0195% CI: [0.1, 0.9]ANCOVA
Comparison: Serotype 12F, Day 30p-value: 0.2695% CI: [-0.7, 0.2]ANCOVA
Comparison: Serotype 12F, Day 30p-value: 0.36695% CI: [-0.3, 0.7]ANCOVA
Comparison: Serotype 12F, Day 30p-value: 0.04695% CI: [0, 1]ANCOVA
Comparison: Serotype 14, Day 30p-value: 0.10195% CI: [-0.8, 0.1]ANCOVA
Comparison: Serotype 14, Day 30p-value: 0.52295% CI: [-0.3, 0.6]ANCOVA
Comparison: Serotype 14, Day 30p-value: 0.02695% CI: [0.1, 1]ANCOVA
Comparison: Serotype 15B, Day 30p-value: 0.23695% CI: [-0.6, 0.2]ANCOVA
Comparison: Serotype 15B, Day 30p-value: 0.52895% CI: [-0.3, 0.5]ANCOVA
Comparison: Serotype 15B, Day 30p-value: 0.08195% CI: [0, 0.8]ANCOVA
Comparison: Serotype 17F, Day 30p-value: 0.38895% CI: [-0.5, 0.2]ANCOVA
Comparison: Serotype 17F, Day 30p-value: 0.15195% CI: [-0.1, 0.6]ANCOVA
Comparison: Serotype 17F, Day 30p-value: 0.02495% CI: [0.1, 0.7]ANCOVA
Comparison: Serotype 18C, Day 30p-value: 0.47695% CI: [-0.3, 0.5]ANCOVA
Comparison: Serotype 18C, Day 30p-value: 0.07795% CI: [0, 0.8]ANCOVA
Comparison: Serotype 18C, Day 30p-value: 0.26295% CI: [-0.2, 0.6]ANCOVA
Comparison: Serotype 19A, Day 30p-value: 0.76795% CI: [-0.3, 0.4]ANCOVA
Comparison: Serotype 19A, Day 30p-value: 0.36495% CI: [-0.2, 0.5]ANCOVA
Comparison: Serotype 19A, Day 30p-value: 0.52295% CI: [-0.2, 0.5]ANCOVA
Comparison: Serotype 19F, Day 30p-value: 0.96295% CI: [-0.4, 0.4]ANCOVA
Comparison: Serotype 19F, Day 30p-value: 0.09195% CI: [-0.1, 0.7]ANCOVA
Comparison: Serotype 19F, Day 30p-value: 0.09395% CI: [-0.1, 0.7]ANCOVA
Comparison: Serotype 20B, Day 30p-value: 0.45595% CI: [-0.6, 0.3]ANCOVA
Comparison: Serotype 20B, Day 30p-value: 0.09395% CI: [-0.1, 0.9]ANCOVA
Comparison: Serotype 20B, Day 30p-value: 0.01795% CI: [0.1, 1.1]ANCOVA
Comparison: Serotype 22F, Day 30p-value: 0.56195% CI: [-0.5, 0.3]ANCOVA
Comparison: Serotype 22F, Day 30p-value: 0.34395% CI: [-0.2, 0.6]ANCOVA
Comparison: Serotype 22F, Day 30p-value: 0.13295% CI: [-0.1, 0.7]ANCOVA
Comparison: Serotype 23F, Day 30p-value: 0.89895% CI: [-0.5, 0.6]ANCOVA
Comparison: Serotype 23F, Day 30p-value: 0.31395% CI: [-0.3, 0.9]ANCOVA
Comparison: Serotype 23F, Day 30p-value: 0.36695% CI: [-0.3, 0.8]ANCOVA
Comparison: Serotype 33F, Day 30p-value: 0.96195% CI: [-0.4, 0.4]ANCOVA
Comparison: Serotype 33F, Day 30p-value: 0.26995% CI: [-0.2, 0.6]ANCOVA
Comparison: Serotype 33F, Day 30p-value: 0.24595% CI: [-0.2, 0.6]ANCOVA
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.
Time frame: At Day 30
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 22F, Day 30 | 8.1 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 14, Day 30 | 8.8 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 6B, Day 30 | 8.1 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 20B, Day 30 | 6.9 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 12F, Day 30 | 6.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 7F, Day 30 | 8.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 2, Day 30 | 9.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 11A, Day 30 | 8.1 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 8, Day 30 | 9.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 19F, Day 30 | 8.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 10A, Day 30 | 9.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 9N, Day 30 | 8.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 19A, Day 30 | 8.8 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 9V, Day 30 | 7.9 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 3, Day 30 | 6.8 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 23F, Day 30 | 7.8 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 18C, Day 30 | 8.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 4, Day 30 | 7.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 33F, Day 30 | 9.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 17F, Day 30 | 9.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 5, Day 30 | 8.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 1, Day 30 | 8.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 15B, Day 30 | 9.1 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 6A, Day 30 | 8.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 20B, Day 30 | 7.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 18C, Day 30 | 8.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 19F, Day 30 | 8.9 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 33F, Day 30 | 9.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 1, Day 30 | 8.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 2, Day 30 | 9.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 3, Day 30 | 7.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 4, Day 30 | 7.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 5, Day 30 | 8.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 6A, Day 30 | 8.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 6B, Day 30 | 8.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 7F, Day 30 | 8.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 8, Day 30 | 9.1 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 9N, Day 30 | 8.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 9V, Day 30 | 8.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 10A, Day 30 | 9.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 12F, Day 30 | 6.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 14, Day 30 | 9.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 15B, Day 30 | 9.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 17F, Day 30 | 9.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 19A, Day 30 | 9.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 11A, Day 30 | 8.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 22F, Day 30 | 8.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 23F, Day 30 | 7.8 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 6A, Day 30 | 8.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 12F, Day 30 | 6.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 5, Day 30 | 8.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 22F, Day 30 | 8.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 15B, Day 30 | 10.0 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 4, Day 30 | 7.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 14, Day 30 | 9.3 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 17F, Day 30 | 9.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 3, Day 30 | 7.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 2, Day 30 | 9.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 33F, Day 30 | 9.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 19A, Day 30 | 9.1 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 19F, Day 30 | 9.1 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 1, Day 30 | 8.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 10A, Day 30 | 9.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 9N, Day 30 | 9.2 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 23F, Day 30 | 8.1 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 9V, Day 30 | 8.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 8, Day 30 | 9.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 20B, Day 30 | 7.4 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 7F, Day 30 | 8.5 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 11A, Day 30 | 8.6 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 6B, Day 30 | 8.7 ln(titers) |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2] | Serotype 18C, Day 30 | 8.5 ln(titers) |
Comparison: Serotype 1, Day 30p-value: 0.21395% CI: [-0.1, 0.7]ANCOVA
Comparison: Serotype 1, Day 30p-value: 0.09795% CI: [-0.1, 0.8]ANCOVA
Comparison: Serotype 1, Day 30p-value: 0.63195% CI: [-0.3, 0.5]ANCOVA
Comparison: Serotype 2, Day 30p-value: 0.69995% CI: [-0.3, 0.4]ANCOVA
Comparison: Serotype 2, Day 30p-value: 0.04295% CI: [0, 0.7]ANCOVA
Comparison: Serotype 2, Day 30p-value: 0.09295% CI: [-0.1, 0.7]ANCOVA
Comparison: Serotype 3, Day 30p-value: 0.00795% CI: [0.1, 0.8]ANCOVA
Comparison: Serotype 3, Day 30p-value: <0.00195% CI: [0.3, 1]ANCOVA
Comparison: Serotype 3, Day 30p-value: 0.23795% CI: [-0.1, 0.6]ANCOVA
Comparison: Serotype 4, Day 30p-value: 0.24895% CI: [-0.2, 0.6]ANCOVA
Comparison: Serotype 4, Day 30p-value: 0.19395% CI: [-0.1, 0.7]ANCOVA
Comparison: Serotype 4, Day 30p-value: 0.83895% CI: [-0.4, 0.5]ANCOVA
Comparison: Serotype 5, Day 30p-value: 0.89895% CI: [-0.5, 0.4]ANCOVA
Comparison: Serotype 5, Day 30p-value: 0.14395% CI: [-0.1, 0.9]ANCOVA
Comparison: Serotype 5, Day 30p-value: 0.10895% CI: [-0.1, 0.9]ANCOVA
Comparison: Serotype 6A, Day 30p-value: 0.39695% CI: [-0.3, 0.7]ANCOVA
Comparison: Serotype 6A, Day 30p-value: 0.18295% CI: [-0.2, 0.9]ANCOVA
Comparison: Serotype 6A, Day 30p-value: 0.59395% CI: [-0.4, 0.6]ANCOVA
Comparison: Serotype 6B, Day 30p-value: 0.18695% CI: [-0.2, 0.9]ANCOVA
Comparison: Serotype 6B, Day 30p-value: 0.03895% CI: [0, 1.1]ANCOVA
Comparison: Serotype 6B, Day 30p-value: 0.40895% CI: [-0.3, 0.8]ANCOVA
Comparison: Serotype 7F, Day 30p-value: 0.80595% CI: [-0.3, 0.4]ANCOVA
Comparison: Serotype 7F, Day 30p-value: 0.71195% CI: [-0.3, 0.5]ANCOVA
Comparison: Serotype 7F, Day 30p-value: 0.89195% CI: [-0.4, 0.4]ANCOVA
Comparison: Serotype 8, Day 30p-value: 0.64995% CI: [-0.3, 0.4]ANCOVA
Comparison: Serotype 8, Day 30p-value: <0.00195% CI: [0.3, 1]ANCOVA
Comparison: Serotype 8, Day 30p-value: <0.00195% CI: [0.3, 0.9]ANCOVA
Comparison: Serotype 9N, Day 30p-value: 0.45495% CI: [-0.2, 0.5]ANCOVA
Comparison: Serotype 9N, Day 30p-value: 0.00395% CI: [0.2, 1]ANCOVA
Comparison: Serotype 9N, Day 30p-value: 0.02195% CI: [0.1, 0.9]ANCOVA
Comparison: Serotype 9V, Day 30p-value: 0.20595% CI: [-0.1, 0.6]ANCOVA
Comparison: Serotype 9V, Day 30p-value: 0.01595% CI: [0.1, 0.9]ANCOVA
Comparison: Serotype 9V, Day 30p-value: 0.20995% CI: [-0.1, 0.7]ANCOVA
Comparison: Serotype 10A, Day 30p-value: 0.50295% CI: [-0.3, 0.6]ANCOVA
Comparison: Serotype 10A, Day 30p-value: 0.05495% CI: [0, 1]ANCOVA
Comparison: Serotype 10A, Day 30p-value: 0.1995% CI: [-0.2, 0.8]ANCOVA
Comparison: Serotype 11A, Day 30p-value: 0.61695% CI: [-0.3, 0.4]ANCOVA
Comparison: Serotype 11A, Day 30p-value: 0.01895% CI: [0.1, 0.8]ANCOVA
Comparison: Serotype 11A, Day 30p-value: 0.05695% CI: [0, 0.7]ANCOVA
Comparison: Serotype 12F, Day 30p-value: 0.52795% CI: [-0.4, 0.7]ANCOVA
Comparison: Serotype 12F, Day 30p-value: 0.44495% CI: [-0.4, 0.8]ANCOVA
Comparison: Serotype 12F, Day 30p-value: 0.86995% CI: [-0.5, 0.6]ANCOVA
Comparison: Serotype 14, Day 30p-value: 0.30595% CI: [-0.2, 0.7]ANCOVA
Comparison: Serotype 14, Day 30p-value: 0.04695% CI: [0, 1]ANCOVA
Comparison: Serotype 14, Day 30p-value: 0.29995% CI: [-0.2, 0.8]ANCOVA
Comparison: Serotype 15B, Day 30p-value: 0.1495% CI: [-0.1, 0.7]ANCOVA
Comparison: Serotype 15B, Day 30p-value: <0.00195% CI: [0.4, 1.3]ANCOVA
Comparison: Serotype 15B, Day 30p-value: 0.01295% CI: [0.1, 1]ANCOVA
Comparison: Serotype 17F, Day 30p-value: 0.295% CI: [-0.1, 0.6]ANCOVA
Comparison: Serotype 17F, Day 30p-value: 0.03795% CI: [0, 0.8]ANCOVA
Comparison: Serotype 17F, Day 30p-value: 0.3895% CI: [-0.2, 0.6]ANCOVA
Comparison: Serotype 18C, Day 30p-value: 0.00695% CI: [0.2, 1]ANCOVA
Comparison: Serotype 18C, Day 30p-value: 0.01895% CI: [0.1, 1]ANCOVA
Comparison: Serotype 18C, Day 30p-value: 0.8195% CI: [-0.5, 0.4]ANCOVA
Comparison: Serotype 19A, Day 30p-value: 0.17395% CI: [-0.1, 0.7]ANCOVA
Comparison: Serotype 19A, Day 30p-value: 0.09695% CI: [-0.1, 0.8]ANCOVA
Comparison: Serotype 19A, Day 30p-value: 0.7195% CI: [-0.3, 0.5]ANCOVA
Comparison: Serotype 19F, Day 30p-value: 0.195% CI: [-0.1, 0.8]ANCOVA
Comparison: Serotype 19F, Day 30p-value: 0.00795% CI: [0.2, 1.1]ANCOVA
Comparison: Serotype 19F, Day 30p-value: 0.25195% CI: [-0.2, 0.7]ANCOVA
Comparison: Serotype 20B, Day 30p-value: 0.61895% CI: [-0.3, 0.5]ANCOVA
Comparison: Serotype 20B, Day 30p-value: 0.04195% CI: [0, 0.9]ANCOVA
Comparison: Serotype 20B, Day 30p-value: 0.11195% CI: [-0.1, 0.8]ANCOVA
Comparison: Serotype 22F, Day 30p-value: 0.75895% CI: [-0.3, 0.4]ANCOVA
Comparison: Serotype 22F, Day 30p-value: 0.01295% CI: [0.1, 0.9]ANCOVA
Comparison: Serotype 22F, Day 30p-value: 0.02595% CI: [0.1, 0.8]ANCOVA
Comparison: Serotype 23F, Day 30p-value: 0.91295% CI: [-0.5, 0.4]ANCOVA
Comparison: Serotype 23F, Day 30p-value: 0.17495% CI: [-0.1, 0.8]ANCOVA
Comparison: Serotype 23F, Day 30p-value: 0.13895% CI: [-0.1, 0.8]ANCOVA
Comparison: Serotype 33F, Day 30p-value: 0.26795% CI: [-0.2, 0.7]ANCOVA
Comparison: Serotype 33F, Day 30p-value: 0.395% CI: [-0.2, 0.7]ANCOVA
Comparison: Serotype 33F, Day 30p-value: 0.98295% CI: [-0.4, 0.4]ANCOVA
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.
Time frame: At Day 1 and Day 30
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 18C, Day 30 | 6975.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 5, Day 30 | 7426.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 18C, Day 1 | 282.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 3, Day 1 | 103.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19F, Day 30 | 7144.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 14, Day 1 | 837.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 9V, Day 30 | 3791.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 1, Day 30 | 5174.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6A, Day 30 | 8735.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 23F, Day 30 | 5338.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6A, Day 1 | 192.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19F, Day 1 | 498.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6B, Day 1 | 199.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 4, Day 30 | 2709.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 1, Day 1 | 190.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 14, Day 30 | 16115.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6B, Day 30 | 14638.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 23F, Day 1 | 254.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 3, Day 30 | 755.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 7F, Day 1 | 305.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 5, Day 1 | 194.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19A, Day 30 | 6568.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 7F, Day 30 | 7131.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19A, Day 1 | 937.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 9V, Day 1 | 152.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 4, Day 1 | 85.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 9V, Day 1 | 104.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19A, Day 1 | 484.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 9V, Day 30 | 5523.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 14, Day 1 | 1062.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 18C, Day 30 | 6435.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 14, Day 30 | 17185.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 18C, Day 1 | 221.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 4, Day 1 | 68.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 23F, Day 1 | 236.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 4, Day 30 | 2171.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 1, Day 30 | 7023.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 5, Day 1 | 82.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 1, Day 1 | 177.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19F, Day 30 | 9886.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 5, Day 30 | 3946.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6A, Day 1 | 206.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 3, Day 1 | 135.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19F, Day 1 | 477.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6A, Day 30 | 7585.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6B, Day 1 | 155.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 23F, Day 30 | 5759.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19A, Day 30 | 8343.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6B, Day 30 | 8728.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 7F, Day 1 | 234.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 7F, Day 30 | 7580.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 3, Day 30 | 1465.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 3, Day 30 | 2115.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 1, Day 1 | 252.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 1, Day 30 | 11097.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 3, Day 1 | 101.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 4, Day 1 | 103.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 4, Day 30 | 4778.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 5, Day 1 | 105.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 5, Day 30 | 6973.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6A, Day 1 | 175.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6A, Day 30 | 6805.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6B, Day 1 | 130.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6B, Day 30 | 10206.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 9V, Day 1 | 119.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 9V, Day 30 | 6681.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 14, Day 1 | 363.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 14, Day 30 | 33150.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 18C, Day 1 | 258.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 18C, Day 30 | 6911.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19A, Day 1 | 581.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19A, Day 30 | 8461.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19F, Day 1 | 380.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19F, Day 30 | 10142.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 23F, Day 1 | 230.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 23F, Day 30 | 7435.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 7F, Day 1 | 342.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 7F, Day 30 | 11037.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 7F, Day 1 | 202.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6B, Day 1 | 162.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 23F, Day 30 | 11580.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19A, Day 30 | 9721.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6A, Day 30 | 9819.2 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6A, Day 1 | 161.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 1, Day 30 | 7407.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19F, Day 1 | 340.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 5, Day 30 | 4691.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 5, Day 1 | 113.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 1, Day 1 | 177.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19F, Day 30 | 7176.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 4, Day 30 | 2129.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 4, Day 1 | 83.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 6B, Day 30 | 11576.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 23F, Day 1 | 251.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 3, Day 30 | 547.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 18C, Day 1 | 206.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 14, Day 30 | 15893.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 14, Day 1 | 408.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 3, Day 1 | 82.2 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 18C, Day 30 | 6405.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 9V, Day 30 | 3968.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 9V, Day 1 | 139.9 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 7F, Day 30 | 3830.9 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1] | Serotype 19A, Day 1 | 582.8 Titers |
Comparison: Serotype 1, Day 195% CI: [0.52, 2.23]t-test, 2 sided
Comparison: Serotype 1, Day 195% CI: [0.51, 1.98]t-test, 2 sided
Comparison: Serotype 1, Day 195% CI: [0.72, 2.83]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [0.59, 2.68]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [0.9, 3.05]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [0.68, 2.25]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.49, 2.15]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.39, 1.74]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.59, 2.59]t-test, 2 sided
Comparison: Serotype 5, Day 195% CI: [0.75, 3.91]t-test, 2 sided
Comparison: Serotype 5, Day 195% CI: [0.36, 1.46]t-test, 2 sided
Comparison: Serotype 5, Day 195% CI: [0.47, 1.84]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.57, 2.52]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.64, 2.56]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.52, 2.28]t-test, 2 sided
Comparison: Serotype 6B, Day 195% CI: [0.49, 3.09]t-test, 2 sided
Comparison: Serotype 6B, Day 195% CI: [0.43, 2.14]t-test, 2 sided
Comparison: Serotype 6B, Day 195% CI: [0.37, 1.73]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.76, 3.01]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.69, 1.94]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.98, 2.91]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.54, 2.22]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.41, 1.36]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.47, 1.55]t-test, 2 sided
Comparison: Serotype 14, Day 195% CI: [0.84, 4.99]t-test, 2 sided
Comparison: Serotype 14, Day 195% CI: [1.13, 5.98]t-test, 2 sided
Comparison: Serotype 14, Day 195% CI: [0.37, 2.15]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.61, 3.06]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.55, 2.09]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.59, 2.65]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.74, 3.49]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.42, 1.65]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.49, 2.05]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.63, 3.39]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.64, 3.07]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.53, 2.34]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.49, 2.09]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.5, 1.75]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.42, 2]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.38, 1.29]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.52, 1.73]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.84, 2.66]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [0.84, 2.28]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [1.71, 4.19]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [2.47, 6.06]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [0.7, 2.3]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [0.57, 1.81]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [1.21, 4.15]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [0.7, 3.57]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [0.35, 2.05]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [0.65, 3.39]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.41, 1.93]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.33, 1.79]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.32, 1.48]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [0.57, 2.83]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [0.31, 1.81]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [0.39, 1.97]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [1.05, 3.3]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [1.1, 3.55]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [1.62, 5.12]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [0.49, 1.87]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [0.74, 2.62]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [0.87, 3.27]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.41, 2.53]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.45, 2.6]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.86, 5.04]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.57, 2.07]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.53, 1.89]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.56, 2.07]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.4, 1.14]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.46, 1.61]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.47, 1.6]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [0.49, 2.01]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [0.75, 2.53]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [0.68, 2.96]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.2, 1.07]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.22, 1.11]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.29, 1.44]t-test, 2 sided
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.
Time frame: At Day 30
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 15B | 16.0 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 10A | 14.8 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 8 | 35.8 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 12F | 17.1 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 11A | 6.8 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 20B | 7.2 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 33F | 17.6 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 22F | 30.4 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 9N | 32.3 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 2 | 29.7 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 17F | 28.2 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 12F | 30.6 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 2 | 34.5 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 8 | 57.7 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 9N | 39.5 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 10A | 10.0 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 11A | 11.2 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 15B | 18.7 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 17F | 48.0 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 20B | 11.4 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 22F | 60.7 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 33F | 37.9 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 20B | 12.7 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 8 | 102.7 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 2 | 66.5 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 33F | 25.5 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 9N | 51.6 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 15B | 32.2 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 17F | 70.4 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 11A | 22.3 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 22F | 52.6 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 10A | 16.2 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 12F | 31.7 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 9N | 3.5 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 15B | 1.5 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 12F | 1.5 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 20B | 1.1 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 8 | 1.3 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 17F | 1.2 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 22F | 1.1 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 33F | 2.2 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 10A | 1.7 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 2 | 1.2 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1] | Serotype 11A | 1.1 fold rise |
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.
Time frame: At Day 1 and Day 30
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 9V, Day 1 | 1106.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 7F, Day 30 | 7185.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6A, Day1 | 64.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19F, Day 30 | 3397.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 7F, Day 1 | 1003.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6B, Day 30 | 7742.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6A, Day 30 | 9817.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 3, Day 1 | 33.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6B, Day 1 | 110.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19A, Day 1 | 732.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19F, Day 1 | 221.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19A, Day 30 | 3879.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 3, Day 30 | 368.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 1, Day 1 | 7.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 4, Day 1 | 46.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 1, Day 30 | 448.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 18C, Day 30 | 6779.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 4, Day 30 | 4038.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 23F, Day 30 | 2947.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 18C, Day 1 | 74.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 14, Day 30 | 5407.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 5, Day 1 | 12.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 23F, Day 1 | 230.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 14, Day 1 | 592.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 9V, Day 30 | 8458.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 5, Day 30 | 1344.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 3, Day 30 | 485.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 1, Day 1 | 7.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 1, Day 30 | 347.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 3, Day 1 | 43.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 4, Day 1 | 29.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 4, Day 30 | 2452.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 5, Day 1 | 8.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6A, Day1 | 55.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6A, Day 30 | 6018.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6B, Day 1 | 119.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6B, Day 30 | 4981.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 7F, Day 1 | 422.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 7F, Day 30 | 6025.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 9V, Day 1 | 279.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 9V, Day 30 | 7789.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 14, Day 1 | 269.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 14, Day 30 | 2805.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 18C, Day 1 | 119.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 18C, Day 30 | 5266.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19A, Day 1 | 469.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19A, Day 30 | 5357.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19F, Day 1 | 391.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19F, Day 30 | 3862.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 23F, Day 1 | 141.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 23F, Day 30 | 2951.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 5, Day 30 | 1193.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 9V, Day 30 | 10532.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 14, Day 30 | 11292.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 3, Day 30 | 432.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19A, Day 30 | 4866.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 1, Day 30 | 337.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 3, Day 1 | 14.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 4, Day 30 | 5211.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19F, Day 1 | 457.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 5, Day 1 | 6.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 18C, Day 1 | 123.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6A, Day 30 | 6953.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 23F, Day 1 | 69.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6B, Day 1 | 65.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 14, Day 1 | 138.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 23F, Day 30 | 3399.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 4, Day 1 | 77.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6B, Day 30 | 4720.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 18C, Day 30 | 6077.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6A, Day1 | 78.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19F, Day 30 | 5636.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 7F, Day 1 | 412.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 9V, Day 1 | 360.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 1, Day 1 | 7.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19A, Day 1 | 489.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 7F, Day 30 | 7223.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 5, Day 30 | 1557.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 7F, Day 30 | 8855.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 9V, Day 1 | 577.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 5, Day 1 | 6.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 9V, Day 30 | 13756.2 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 14, Day 1 | 141.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 4, Day 30 | 4912.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 23F, Day 1 | 103.9 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 14, Day 30 | 9982.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 1, Day 1 | 6.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 18C, Day 1 | 100.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 4, Day 1 | 42.2 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 18C, Day 30 | 7592.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 23F, Day 30 | 15054.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19A, Day 1 | 657.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 3, Day 1 | 21.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19A, Day 30 | 7695.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 3, Day 30 | 337.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19F, Day 1 | 316.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6A, Day 30 | 18733.9 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 1, Day 30 | 482.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6B, Day 1 | 92.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6A, Day1 | 76.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 6B, Day 30 | 10986.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 7F, Day 1 | 1325.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 5, Day 30 | 1954.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1] | Serotype 19F, Day 30 | 6065.2 Titers |
Comparison: Serotype 5, Day 195% CI: [0.62, 2.4]t-test, 2 sided
Comparison: Serotype 5, Day 195% CI: [0.52, 1.65]t-test, 2 sided
Comparison: Serotype 5, Day 195% CI: [0.76, 4.73]t-test, 2 sided
Comparison: Serotype 1, Day 195% CI: [0.7, 1.85]t-test, 2 sided
Comparison: Serotype 1, Day 195% CI: [0.72, 1.9]t-test, 2 sided
Comparison: Serotype 1, Day 195% CI: [0.74, 1.87]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [0.68, 3.63]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [0.86, 4.82]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [0.31, 1.46]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.27, 4.55]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.19, 2.61]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.49, 6.85]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.25, 2.82]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.24, 2.23]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.31, 3.41]t-test, 2 sided
Comparison: Serotype 6B,Day 195% CI: [0.32, 4.46]t-test, 2 sided
Comparison: Serotype 6B, Day 195% CI: [0.42, 4.05]t-test, 2 sided
Comparison: Serotype 6B, Day 195% CI: [0.24, 2.14]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.26, 2.17]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.11, 0.89]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.1, 0.93]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.74, 4.99]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.15, 1.61]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.21, 1.9]t-test, 2 sided
Comparison: Serotype 14, Day 195% CI: [1.17, 15.09]t-test, 2 sided
Comparison: Serotype 14, Day 195% CI: [0.52, 7.07]t-test, 2 sided
Comparison: Serotype 14, Day 195% CI: [0.23, 4.25]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.21, 2.62]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.37, 3.77]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.38, 3.94]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.51, 2.45]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.31, 1.63]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.36, 1.53]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.24, 2.08]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.44, 3.5]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.58, 3.61]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.46, 10.69]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.31, 5.99]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.15, 3.01]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.5, 1.74]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.39, 1.32]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.35, 1.39]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [0.66, 1.8]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [0.9, 2.29]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [0.76, 2.17]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [0.5, 1.35]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [0.24, 1.02]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [0.6, 1.89]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [0.41, 1.15]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [0.31, 1.2]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [0.48, 1.32]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.28, 0.98]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.15, 0.68]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.21, 0.66]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [0.42, 1.18]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [0.25, 0.83]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [0.24, 0.76]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [0.51, 1.29]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [0.47, 0.99]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [0.53, 1.25]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [0.35, 1.08]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [0.31, 1.03]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [0.46, 1.28]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.27, 1.08]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.1, 0.77]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.56, 2.3]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.53, 1.5]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.39, 1.23]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.5, 1.28]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.32, 0.79]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.45, 1.09]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.42, 0.96]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [0.34, 0.92]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [0.37, 1.1]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [0.56, 1.55]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.08, 0.46]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.08, 0.47]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.09, 0.57]t-test, 2 sided
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.
Time frame: At Day 1 and Day 30
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 7F, Day 30 | 5660.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 7F, Day 1 | 279.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 5, Day 30 | 3261.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19F, Day 30 | 5479.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6B, Day 30 | 2835.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6B, Day 1 | 162.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6A, Day 1 | 172.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 3, Day 1 | 76.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6A, Day 30 | 3132.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 23F, Day 30 | 2569.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19F, Day 1 | 357.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19A, Day 30 | 7704.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 3, Day 30 | 846.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 1, Day 1 | 268.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19A, Day 1 | 710.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 18C, Day 30 | 3647.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 4, Day 1 | 128.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 1, Day 30 | 4510.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 14, Day 30 | 7024.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 14, Day 1 | 732.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 4, Day 30 | 1518.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 18C, Day 1 | 313.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 9V, Day 30 | 2990.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 9V, Day 1 | 183.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 5, Day 1 | 175.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 23F, Day 1 | 190.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 3, Day 30 | 1348.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 1, Day 1 | 551.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 1, Day 30 | 5730.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 3, Day 1 | 109.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 4, Day 1 | 183.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 4, Day 30 | 1866.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 5, Day 1 | 258.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 5, Day 30 | 3236.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6A, Day 1 | 270.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6A, Day 30 | 3850.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6B, Day 1 | 291.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6B, Day 30 | 4135.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 7F, Day 1 | 438.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 7F, Day 30 | 5710.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 9V, Day 1 | 364.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 9V, Day 30 | 3798.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 14, Day 1 | 1329.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 14, Day 30 | 8927.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 18C, Day 30 | 6242.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19A, Day 1 | 1157.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19A, Day 30 | 9838.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19F, Day 1 | 542.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19F, Day 30 | 7737.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 23F, Day 1 | 210.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 23F, Day 30 | 2480.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 18C, Day 1 | 695.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 5, Day 1 | 163.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 7F, Day 30 | 6123.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 1, Day 30 | 6436.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 9V, Day 1 | 229.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 4, Day 30 | 2013.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 9V, Day 30 | 5006.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 23F, Day 1 | 210.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 14, Day 1 | 867.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 4, Day 1 | 105.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 14, Day 30 | 11822.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 18C, Day 1 | 354.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 3, Day 30 | 1657.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 18C, Day 30 | 6189.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19A, Day 1 | 906.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 23F, Day 30 | 3535.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19A, Day 30 | 11047.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 3, Day 1 | 65.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19F, Day 1 | 424.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6A, Day 1 | 273.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6A, Day 30 | 4438.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6B, Day 1 | 221.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 5, Day 30 | 4752.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 1, Day 1 | 263.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6B, Day 30 | 5088.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19F, Day 30 | 10186.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 7F, Day 1 | 250.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6A, Day 30 | 3640.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19F, Day 30 | 4568.2 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19A, Day 1 | 867.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 7F, Day 30 | 3684.2 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 4, Day 30 | 1923.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 3, Day 1 | 60.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 5, Day 30 | 2490.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 9V, Day 1 | 232.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 1, Day 30 | 5510.9 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 18C, Day 30 | 6012.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19A, Day 30 | 9233.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 9V, Day 30 | 2316.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 4, Day 1 | 158.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 7F, Day 1 | 276.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 23F, Day 30 | 2989.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 14, Day 1 | 997.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6B, Day 1 | 139.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 23F, Day 1 | 176.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6A, Day 1 | 195.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 14, Day 30 | 7087.9 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 6B, Day 30 | 2869.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 18C, Day 1 | 454.9 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 3, Day 30 | 409.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 1, Day 1 | 297.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 19F, Day 1 | 429.9 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Serotype-specific IgG, [Stage 2, Group 2] | Serotype 5, Day 1 | 162.9 Titers |
Comparison: Serotype 1, Day 195% CI: [0.57, 1.42]t-test, 2 sided
Comparison: Serotype 1, Day 195% CI: [1.12, 3.08]t-test, 2 sided
Comparison: Serotype 1, Day 195% CI: [0.53, 1.49]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [0.84, 1.87]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [1.18, 2.73]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [0.69, 1.69]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.54, 1.21]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.74, 1.81]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.44, 1]t-test, 2 sided
Comparison: Serotype 5, Day 195% CI: [0.65, 1.78]t-test, 2 sided
Comparison: Serotype 5, Day 195% CI: [0.96, 2.63]t-test, 2 sided
Comparison: Serotype 5, Day 195% CI: [0.58, 1.72]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.53, 1.47]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.83, 2.3]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.8, 2.44]t-test, 2 sided
Comparison: Serotype 6B, Day 195% CI: [0.69, 1.99]t-test, 2 sided
Comparison: Serotype 6B, Day 195% CI: [1.19, 3.67]t-test, 2 sided
Comparison: Serotype 6B, Day 195% CI: [0.88, 2.88]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.62, 1.65]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.94, 2.67]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.5, 1.64]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.52, 1.21]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.97, 2.54]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.6, 1.6]t-test, 2 sided
Comparison: Serotype 14, Day 195% CI: [0.4, 1.33]t-test, 2 sided
Comparison: Serotype 14, Day 195% CI: [0.73, 2.44]t-test, 2 sided
Comparison: Serotype 14, Day 195% CI: [0.46, 1.63]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.42, 1.12]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.92, 2.55]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.44, 1.37]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.54, 1.25]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.84, 2.12]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.66, 1.66]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.51, 1.37]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.75, 2.11]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.57, 1.72]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.63, 1.86]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.69, 2.08]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.67, 2.14]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.52, 1.29]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.68, 1.59]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.76, 1.8]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [1.42, 3.01]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [2.37, 4.58]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [2.83, 5.79]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [0.49, 1.27]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [0.63, 1.48]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [0.66, 1.65]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [0.75, 2.29]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [0.77, 2.19]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [1.08, 3.37]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.5, 1.49]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.65, 1.72]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.71, 2.1]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [0.56, 1.75]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [0.84, 2.47]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [1, 3.15]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [1.02, 2.3]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [1.06, 2.26]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [1.09, 2.53]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [0.81, 2.07]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [1.04, 2.57]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [1.35, 3.47]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.58, 1.68]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.77, 2.05]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.99, 2.81]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.39, 0.95]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.7, 1.54]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.67, 1.57]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.56, 1.25]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.75, 1.52]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.77, 1.86]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [0.76, 1.9]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [1.11, 2.58]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [1.41, 3.52]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.5, 1.47]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.51, 1.35]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.69, 2.02]t-test, 2 sided
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.
Time frame: At Day 30
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 9N | 5768.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 17F | 9259.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 22F | 3385.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 8 | 9677.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 11A | 4445.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 2 | 12372.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 20B | 863.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 15B | 9320.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 12F | 556.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 33F | 15822.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 10A | 10809.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 11A | 4602.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 2 | 13002.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 12F | 675.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 17F | 11508.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 8 | 10169.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 9N | 6616.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 10A | 12474.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 15B | 12611.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 20B | 991.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 22F | 3577.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 33F | 19432.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 9N | 10826.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 11A | 6928.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 12F | 696.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 20B | 1355.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 33F | 19959.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 10A | 17483.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 2 | 18046.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 22F | 5462.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 17F | 14067.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 15B | 22041.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 8 | 19090.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 17F | 3517.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 15B | 7515.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 9N | 3619.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 12F | 424.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 10A | 4815.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 11A | 2423.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 8 | 6416.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 22F | 1359.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 33F | 9459.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 2 | 9152.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3] | Serotype 20B | 355.3 Titers |
Comparison: Serotype 295% CI: [0.95, 1.93]t-test, 2 sided
Comparison: Serotype 895% CI: [1.07, 2.13]t-test, 2 sided
Comparison: Serotype 9N95% CI: [1.09, 2.33]t-test, 2 sided
Comparison: Serotype 10A95% CI: [1.45, 3.47]t-test, 2 sided
Comparison: Serotype 11A95% CI: [1.27, 2.65]t-test, 2 sided
Comparison: Serotype 12F95% CI: [0.77, 2.23]t-test, 2 sided
Comparison: Serotype 15B95% CI: [0.8, 1.91]t-test, 2 sided
Comparison: Serotype 17F95% CI: [1.7, 4.07]t-test, 2 sided
Comparison: Serotype 20B95% CI: [1.61, 3.67]t-test, 2 sided
Comparison: Serotype 22F95% CI: [1.7, 3.65]t-test, 2 sided
Comparison: Serotype 33F95% CI: [1.1, 2.54]t-test, 2 sided
Comparison: Serotype 295% CI: [0.98, 2.07]t-test, 2 sided
Comparison: Serotype 895% CI: [1.11, 2.26]t-test, 2 sided
Comparison: Serotype 9N95% CI: [1.23, 2.72]t-test, 2 sided
Comparison: Serotype 10A95% CI: [1.66, 4.05]
Comparison: Serotype 11A95% CI: [1.32, 2.73]t-test, 2 sided
Comparison: Serotype 12F95% CI: [0.93, 2.71]t-test, 2 sided
Comparison: Serotype 15B95% CI: [1.11, 2.53]t-test, 2 sided
Comparison: Serotype 17F95% CI: [2.17, 4.93]t-test, 2 sided
Comparison: Serotype 20B95% CI: [1.85, 4.22]t-test, 2 sided
Comparison: Serotype 22F95% CI: [1.79, 3.88]t-test, 2 sided
Comparison: Serotype 33F95% CI: [1.4, 3.01]t-test, 2 sided
Comparison: Serotype 295% CI: [1.37, 2.84]t-test, 2 sided
Comparison: Serotype 895% CI: [2.12, 4.18]t-test, 2 sided
Comparison: Serotype 9N95% CI: [2.02, 4.44]t-test, 2 sided
Comparison: Serotype 10A95% CI: [2.25, 5.86]t-test, 2 sided
Comparison: Serotype 11A95% CI: [1.96, 4.18]t-test, 2 sided
Comparison: Serotype 12F95% CI: [0.91, 2.96]t-test, 2 sided
Comparison: Serotype 15B95% CI: [1.87, 4.61]t-test, 2 sided
Comparison: Serotype 17F95% CI: [2.55, 6.26]t-test, 2 sided
Comparison: Serotype 22F95% CI: [2.46, 5.91]t-test, 2 sided
Comparison: Serotype 22F95% CI: [2.74, 5.9]t-test, 2 sided
Comparison: Serotype 33F95% CI: [1.38, 3.23]t-test, 2 sided
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.
Time frame: At Day 30
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 2 | 17.0 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 22F | 20.5 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 17F | 26.4 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 8 | 24.4 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 20B | 10.1 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 10A | 13.9 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 9N | 19.5 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 11A | 10.5 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 12F | 10.6 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 33F | 12.2 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 15B | 13.0 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 12F | 11.6 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 15B | 9.6 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 11A | 9.9 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 17F | 17.1 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 2 | 12.2 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 20B | 10.4 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 33F | 10.5 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 9N | 12.4 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 22F | 16.2 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 10A | 11.9 fold rise |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 8 | 18.0 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 15B | 20.3 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 8 | 45.7 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 9N | 32.0 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 10A | 19.3 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 11A | 18.2 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 12F | 14.4 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 17F | 27.2 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 20B | 15.6 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 22F | 30.5 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 33F | 16.7 fold rise |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 2 | 22.6 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 12F | 1.1 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 10A | 1.1 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 22F | 1.1 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 11A | 1.1 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 9N | 2.3 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 33F | 1.1 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 8 | 1.2 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 17F | 1.1 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 2 | 1.0 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 20B | 1.1 fold rise |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMFR for Unique Serotypes IgG, [Stage 2, Group 2] | Serotype 15B | 1.8 fold rise |
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.
Time frame: At Day 1 and Day 30
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 9V, Day 30 | 1715.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 1, Day 30 | 158.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19F, Day 1 | 79.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 14, Day 1 | 85.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6A, Day 1 | 30.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 4, Day 1 | 14.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 18C, Day 1 | 38.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19A, Day 30 | 2062.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 18C, Day 30 | 1325.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19A, Day 1 | 128.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 4, Day 30 | 718.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 5, Day 30 | 394.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 5, Day 1 | 12.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 1, Day 1 | 8.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 3, Day 1 | 17.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6A, Day 30 | 1409.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6B, Day 1 | 79.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 14, Day 30 | 1912.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 23F, Day 30 | 537.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6B, Day 30 | 2194.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 7F, Day 1 | 91.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 23F, Day 1 | 26.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 7F, Day 30 | 2631.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 3, Day 30 | 276.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19F, Day 30 | 1672.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 9V, Day 1 | 80.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 7F, Day 1 | 146.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 9V, Day 30 | 1453.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19F, Day 30 | 1626.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 23F, Day 1 | 32.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 23F, Day 30 | 567.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 14, Day 1 | 153.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 3, Day 1 | 19.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 14, Day 30 | 1273.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6A, Day 1 | 51.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19A, Day 30 | 2081.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6A, Day 30 | 1834.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 18C, Day 1 | 98.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 4, Day 1 | 19.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 3, Day 30 | 390.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6B, Day 1 | 82.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 18C, Day 30 | 1461.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 1, Day 30 | 165.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19F, Day 1 | 84.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19A, Day 1 | 193.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 5, Day 30 | 456.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 7F, Day 30 | 2742.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 4, Day 30 | 691.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 1, Day 1 | 15.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 9V, Day 1 | 96.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6B, Day 30 | 1978.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 5, Day 1 | 17.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 23F, Day 30 | 722.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 1, Day 30 | 242.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 3, Day 1 | 12.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 3, Day 30 | 480.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 4, Day 1 | 12.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 4, Day 30 | 903.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 5, Day 1 | 11.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 5, Day 30 | 678.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6A, Day 1 | 51.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6B, Day 1 | 84.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6B, Day 30 | 1941.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 7F, Day 1 | 112.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 7F, Day 30 | 3230.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 9V, Day 1 | 82.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 9V, Day 30 | 2503.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 14, Day 1 | 186.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 14, Day 30 | 2221.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 18C, Day 1 | 41.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 18C, Day 30 | 1951.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19A, Day 1 | 141.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19A, Day 30 | 2417.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19F, Day 1 | 62.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19F, Day 30 | 2295.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 23F, Day 1 | 27.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 1, Day 1 | 7.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6A, Day 30 | 1900.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 9V, Day 1 | 123.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6A, Day 1 | 31.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19F, Day 1 | 100.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 18C, Day 30 | 1483.9 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 7F, Day 30 | 3084.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 1, Day 30 | 189.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19F, Day 30 | 1102.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 7F, Day 1 | 108.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6B, Day 30 | 2324.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 14, Day 1 | 141.2 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6B, Day 1 | 71.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 5, Day 30 | 315.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 5, Day 1 | 13.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 23F, Day 30 | 800.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 1, Day 1 | 10.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 4, Day 30 | 732.9 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 4, Day 1 | 18.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 3, Day 30 | 153.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 3, Day 1 | 13.2 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 23F, Day 1 | 23.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19A, Day 1 | 167.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 18C, Day 1 | 71.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 14, Day 30 | 1437.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 6A, Day 30 | 2045.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 19A, Day 30 | 2115.0 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2] | Serotype 9V, Day 30 | 2060.2 Titers |
Comparison: Serotype 1, Day 195% CI: [0.56, 1.14]t-test, 2 sided
Comparison: Serotype 1, Day 195% CI: [0.89, 2.16]t-test, 2 sided
Comparison: Serotype 1, Day 195% CI: [0.51, 1.06]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [0.85, 2.09]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [0.91, 2.3]t-test, 2 sided
Comparison: Serotype 3, Day 195% CI: [0.6, 1.49]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.46, 1.4]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.62, 1.91]t-test, 2 sided
Comparison: Serotype 4, Day 195% CI: [0.4, 1.23]t-test, 2 sided
Comparison: Serotype 5, Day 195% CI: [0.58, 1.68]t-test, 2 sided
Comparison: Serotype 5, Day 195% CI: [0.76, 2.29]t-test, 2 sided
Comparison: Serotype 5, Day 195% CI: [0.51, 1.53]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.54, 1.72]t-test, 2 sided
Comparison: Serotype 6B, Day 195% CI: [0.57, 2.14]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.86, 3.1]t-test, 2 sided
Comparison: Serotype 6A, Day 195% CI: [0.83, 3.14]t-test, 2 sided
Comparison: Serotype 6B, Day 195% CI: [0.59, 2.24]t-test, 2 sided
Comparison: Serotype 6B, Day 195% CI: [0.58, 2.39]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.4, 1.8]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.63, 2.87]t-test, 2 sided
Comparison: Serotype 7F, Day 195% CI: [0.45, 2.37]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.32, 1.32]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.37, 1.64]t-test, 2 sided
Comparison: Serotype 9V, Day 195% CI: [0.3, 1.49]t-test, 2 sided
Comparison: Serotype 14, Day 195% CI: [0.31, 1.18]t-test, 1 sided
Comparison: Serotype 14, Day 195% CI: [0.54, 2.18]t-test, 2 sided
Comparison: Serotype 14, Day 195% CI: [0.66, 2.65]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.3, 0.95]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.73, 2.57]t-test, 2 sided
Comparison: Serotype 18C, Day 195% CI: [0.32, 1.04]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.44, 1.32]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.66, 2.01]t-test, 2 sided
Comparison: Serotype 19A, Day 195% CI: [0.48, 1.5]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.45, 1.38]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.47, 1.52]t-test, 2 sided
Comparison: Serotype 19F, Day 195% CI: [0.34, 1.12]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.64, 1.94]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.77, 2.42]t-test, 2 sided
Comparison: Serotype 23F, Day 195% CI: [0.66, 2.14]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.47, 1.47]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.5, 1.53]t-test, 2 sided
Comparison: Serotype 1, Day 3095% CI: [0.74, 2.2]t-test, 2 sided
Comparison: Serotype 2, Day 3095% CI: [16.33, 38.34]t-test, 2 sided
Comparison: Serotype 2, Day 3095% CI: [14.31, 33.77]t-test, 2 sided
Comparison: Serotype 2, Day 3095% CI: [23.09, 54.22]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [1.25, 2.62]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [1.83, 3.56]t-test, 2 sided
Comparison: Serotype 3, Day 3095% CI: [2.2, 4.48]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [0.59, 1.62]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [0.59, 1.51]t-test, 2 sided
Comparison: Serotype 4, Day 3095% CI: [0.76, 1.99]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [0.71, 2.21]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [0.85, 2.46]t-test, 2 sided
Comparison: Serotype 5, Day 3095% CI: [1.25, 3.72]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [0.59, 1.51]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [0.56, 1.29]t-test, 2 sided
Comparison: Serotype 6B, Day 3095% CI: [0.54, 1.3]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [0.61, 1.18]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [0.65, 1.21]t-test, 2 sided
Comparison: Serotype 7F, Day 3095% CI: [0.73, 1.5]t-test, 2 sided
Comparison: Serotype 8, Day 3095% CI: [12.26, 30.87]t-test, 2 sided
Comparison: Serotype 8, Day 3095% CI: [12.07, 32]t-test, 2 sided
Comparison: Serotype 8, Day 3095% CI: [26.2, 66.9]t-test, 2 sided
Comparison: Serotype 9N, Day 3095% CI: [3.06, 7.36]t-test, 2 sided
Comparison: Serotype 9N, Day 3095% CI: [3.83, 8.37]t-test, 2 sided
Comparison: Serotype 9N, Day 3095% CI: [5.19, 11.82]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [0.49, 1.42]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [0.44, 1.14]t-test, 2 sided
Comparison: Serotype 9V, Day 3095% CI: [0.76, 1.95]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.39, 1.21]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.54, 1.5]t-test, 2 sided
Comparison: Serotype 6A, Day 3095% CI: [0.53, 1.64]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.84, 2.11]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.55, 1.43]t-test, 2 sided
Comparison: Serotype 14, Day 3095% CI: [0.95, 2.5]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.55, 1.44]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.63, 1.54]t-test, 2 sided
Comparison: Serotype 18C, Day 3095% CI: [0.82, 2.12]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.7, 1.37]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.71, 1.37]t-test, 2 sided
Comparison: Serotype 19A, Day 3095% CI: [0.78, 1.67]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [0.99, 2.32]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [1, 2.18]t-test, 2 sided
Comparison: Serotype 19F, Day 3095% CI: [1.35, 3.22]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.36, 1.26]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.4, 1.26]t-test, 2 sided
Comparison: Serotype 23F, Day 3095% CI: [0.47, 1.73]t-test, 2 sided
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.
Time frame: At Day 30
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 20B | 17250.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 22F | 6897.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 8 | 2122.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 11A | 2020.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 2 | 5702.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 12F | 5536.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 9N | 8525.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 10A | 5542.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 33F | 13291.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 15B | 17128.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 17F | 15011.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 15B | 15042.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 17F | 10352.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 22F | 9221.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 20B | 37410.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 9N | 10826.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 11A | 2034.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 10A | 6094.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 2 | 5966.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 33F | 16419.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 12F | 6501.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 8 | 2000.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 2 | 6963.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 8 | 3254.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 9N | 10215.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 10A | 7764.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 12F | 6630.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 15B | 21608.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 17F | 18396.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 20B | 36949.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 22F | 7085.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 33F | 21934.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 11A | 3195.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 22F | 628.2 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 12F | 358.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 11A | 244.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 15B | 2497.2 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 33F | 647.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 2 | 177.9 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 10A | 189.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 9N | 2856.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 20B | 1828.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 17F | 388.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1] | Serotype 8 | 37.0 Titers |
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.
Time frame: At Day 30
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 11A | 427.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 8 | 1297.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 12F | 1364.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 15B | 6095.8 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 17F | 4308.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 9N | 3200.2 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 33F | 6822.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 2 | 1506.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 22F | 2017.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 10A | 1958.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 20B | 15461.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 20B | 12442.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 33F | 6265.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 15B | 4539.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 17F | 3528.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 2 | 1323.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 8 | 1310.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 11A | 509.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 22F | 1741.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 9N | 3814.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 10A | 2574.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 12F | 1014.9 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 22F | 2442.6 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 10A | 2912.5 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 11A | 872.7 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 2 | 2130.1 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 8 | 2792.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 9N | 5279.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 12F | 1712.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 15B | 6988.4 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 17F | 5567.0 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 20B | 23411.3 Titers |
| Stage 1, Group 1 Adults, ASP3772 High Dose | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 33F | 8579.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 10A | 898.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 33F | 5072.8 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 20B | 1708.7 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 9N | 2362.1 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 8 | 1342.6 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 2 | 1012.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 22F | 1126.2 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 17F | 1653.4 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 15B | 4147.3 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 11A | 359.5 Titers |
| Stage 1, Group 1, PCV13 Pooled Comparator | GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3] | Serotype 12F | 1133.9 Titers |
Comparison: Serotype 295% CI: [1.06, 2.08]t-test, 2 sided
Comparison: Serotype 895% CI: [0.68, 1.37]t-test, 2 sided
Comparison: Serotype 9N95% CI: [0.92, 2]t-test, 2 sided
Comparison: Serotype 10A95% CI: [1.25, 3.79]t-test, 2 sided
Comparison: Serotype 11A95% CI: [0.8, 1.77]t-test, 2 sided
Comparison: Serotype 12F95% CI: [0.73, 2]t-test, 2 sided
Comparison: Serotype 15B95% CI: [0.94, 2.29]t-test, 2 sided
Comparison: Serotype 17F95% CI: [1.68, 4.04]t-test, 2 sided
Comparison: Serotype 20B95% CI: [5.65, 14.5]t-test, 2 sided
Comparison: Serotype 22F95% CI: [1.09, 2.95]t-test, 2 sided
95% CI: [0.86, 2.11]t-test, 2 sided
Comparison: Serotype 295% CI: [0.93, 1.83]t-test, 2 sided
Comparison: Serotype 895% CI: [0.67, 1.43]t-test, 2 sided
Comparison: Serotype 9N95% CI: [1.62, 2.26]t-test, 2 sided
Comparison: Serotype 10A95% CI: [1.68, 4.9]t-test, 2 sided
Comparison: Serotype 11A95% CI: [0.98, 2.06]t-test, 2 sided
Comparison: Serotype 12F95% CI: [0.54, 1.48]t-test, 2 sided
Comparison: Serotype 15B95% CI: [0.73, 1.64]t-test, 2 sided
Comparison: Serotype 17F95% CI: [1.4, 3.25]t-test, 2 sided
Comparison: Serotype 20B95% CI: [4.61, 11.5]t-test, 2 sided
Comparison: Serotype 22F95% CI: [0.96, 2.48]t-test, 2 sided
Comparison: Serotype 33F95% CI: [0.83, 1.84]t-test, 2 sided
Comparison: Serotype 295% CI: [1.51, 2.94]t-test, 2 sided
Comparison: Serotype 895% CI: [1.46, 2.97]t-test, 2 sided
Comparison: Serotype 9N95% CI: [1.56, 3.2]t-test, 2 sided
Comparison: Serotype 10A95% CI: [1.79, 5.89]t-test, 2 sided
Comparison: Serotype 11A95% CI: [1.63, 3.62]t-test, 2 sided
Comparison: Serotype 12 F95% CI: [0.89, 2.55]t-test, 2 sided
Comparison: Serotype 15B95% CI: [1.11, 2.57]t-test, 2 sided
Comparison: Serotype 17F95% CI: [2.18, 5.2]t-test, 2 sided
Comparison: Serotype 20B95% CI: [8.26, 22.72]t-test, 2 sided
Comparison: Serotype 22F95% CI: [1.36, 3.46]t-test, 2 sided
Comparison: Serotype 33F95% CI: [1.11, 2.57]t-test, 2 sided
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.
Time frame: At Day 30
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 20B | 70.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 17F | 90.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 15B | 76.7 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 11A | 56.7 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 9N | 93.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 12F | 90.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 33F | 90.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 8 | 93.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 2 | 93.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 22F | 86.7 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 10A | 90.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 22F | 93.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 2 | 86.7 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 8 | 96.7 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 9N | 90.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 10A | 83.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 11A | 70.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 12F | 93.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 15B | 80.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 17F | 100.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 33F | 100.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 20B | 86.7 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 9N | 90.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 22F | 80.6 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 17F | 93.5 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 15B | 87.1 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 2 | 96.8 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 33F | 96.8 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 20B | 83.9 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 11A | 96.8 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 10A | 90.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 12F | 96.8 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 8 | 96.8 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 12F | 6.3 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 2 | 0 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 15B | 3.1 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 17F | 3.1 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 20B | 0 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 9N | 43.8 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 22F | 0 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 8 | 3.1 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 11A | 0 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 33F | 21.9 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1] | Serotype 10A | 18.8 Percentage of participants |
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.
Time frame: At Day 30
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 12F | 66.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 10A | 82.1 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 22F | 82.1 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 11A | 72.6 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 8 | 85.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 2 | 77.9 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 20B | 81.1 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 17F | 92.6 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 9N | 84.2 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 33F | 75.8 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Low Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 15B | 72.6 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 8 | 75.9 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 2 | 67.8 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 9N | 66.7 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 10A | 74.7 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 11A | 67.8 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 12F | 72.4 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 15B | 65.5 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 20B | 74.7 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 33F | 66.7 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 17F | 82.8 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 Medium Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 22F | 71.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 2 | 81.4 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 9N | 87.1 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 15B | 74.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 17F | 90.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 8 | 87.1 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 33F | 80.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 20B | 84.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 22F | 90.0 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 10A | 85.7 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 11A | 84.3 Percentage of participants |
| Stage 1, Group 1 Adults, ASP3772 High Dose | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 12F | 71.4 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 22F | 1.1 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 12F | 0 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 20B | 1.1 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 33F | 0 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 2 | 1.1 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 15B | 17.0 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 8 | 2.3 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 9N | 25.0 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 17F | 0 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 10A | 1.1 Percentage of participants |
| Stage 1, Group 1, PCV13 Pooled Comparator | Percentage of Participants With Unique Serotype-specific IgG Concentration of Greater Than or Equal to (>=) 4-fold Increase, [Stage 2, Group 2] | Serotype 11A | 0 Percentage of participants |