Trial Outcomes & Findings for A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine (NCT NCT03803202)
NCT ID: NCT03803202
Last Updated: 2023-12-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
630 participants
Primary outcome timeframe
From Day 1, Up to Day 180
Results posted on
2023-12-21
Participant Flow
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.
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.
Participant milestones
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
Healthy adults aged 18 to 64 years received a low dose \[1 microgram (μg)\] of ASP3772 intramuscularly on Day 1.
|
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.
|
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.
|
Stage 1, Group 1, PCV13 Pooled Comparator
Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 milliliter (mL) intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
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.
|
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.
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
32
|
33
|
100
|
107
|
86
|
97
|
113
|
|
Overall Study
Vaccinated
|
30
|
31
|
32
|
33
|
100
|
107
|
86
|
97
|
113
|
|
Overall Study
COMPLETED
|
30
|
31
|
31
|
32
|
99
|
106
|
85
|
96
|
113
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
Healthy adults aged 18 to 64 years received a low dose \[1 microgram (μg)\] of ASP3772 intramuscularly on Day 1.
|
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.
|
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.
|
Stage 1, Group 1, PCV13 Pooled Comparator
Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 milliliter (mL) intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
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.
|
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.
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine
Baseline characteristics by cohort
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 Participants
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).
|
Stage 2, Group 2 Older Adults, ASP3772 Low Dose
n=100 Participants
Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2 Older Adults, ASP3772 Medium Dose
n=107 Participants
Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2 Older Adults, ASP3772 High Dose
n=86 Participants
Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2, PCV13 Pooled Comparator
n=97 Participants
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 3, PPSV23 Comparator
n=113 Participants
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.
|
Total
n=630 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
>=18 to <65 years
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
127 Participants
n=64 Participants
|
|
Age, Customized
>=65 to <75 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
89 Participants
n=10 Participants
|
78 Participants
n=115 Participants
|
84 Participants
n=6 Participants
|
108 Participants
n=6 Participants
|
449 Participants
n=64 Participants
|
|
Age, Customized
>=75 to <=85 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
54 Participants
n=64 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
55 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
52 Participants
n=6 Participants
|
70 Participants
n=6 Participants
|
369 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
52 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
45 Participants
n=6 Participants
|
43 Participants
n=6 Participants
|
261 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
92 Participants
n=10 Participants
|
79 Participants
n=115 Participants
|
78 Participants
n=6 Participants
|
104 Participants
n=6 Participants
|
550 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
16 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
71 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: From Day 1, Up to Day 180Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
Serious Vaccine-Related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
TEAE
|
11 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
Vaccine-Related TEAEs
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
Medically Attended TEAE
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
Potentially Immune Mediated TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
NOCDs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1, Up to Day 180Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=100 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=107 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=86 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=97 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs, [Stage 2, Group 2]
TEAE
|
25 Participants
|
26 Participants
|
28 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 2]
Vaccine-Related TEAEs
|
5 Participants
|
5 Participants
|
8 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 2]
Medically Attended TEAE
|
7 Participants
|
9 Participants
|
7 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 2]
New Onset Chronic TEAEs
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 2]
Serious TEAEs
|
4 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 2]
Potentially Immune Mediated TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 2]
Serious Vaccine-Related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 2]
Death
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1, Up to Day 30Population: The analysis was performed on the Safety Analysis Set which consisted of all randomized participants who received a vaccination in this study with PPSV23.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=113 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
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.
|
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.
|
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs, [Stage 2, Group 3]
TEAE
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 3]
Vaccine-Related TEAEs
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 3]
Medically Attended TEAE
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 3]
New Onset Chronic TEAEs
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 3]
Potentially Immune Mediated TEAEs
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 3]
Serious TEAEs
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 3]
Serious Vaccine-Related TEAE
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, [Stage 2, Group 3]
Death
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 Participants
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).
|
Stage 2, Group 2 Older Adults, ASP3772 Low Dose
n=100 Participants
Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2 Older Adults, ASP3772 Medium Dose
n=107 Participants
Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1
|
Stage 2, Group 2 Older Adults, ASP3772 High Dose
n=86 Participants
Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2, PCV13 Pooled Comparator
n=97 Participants
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 3, PPSV23 Comparator
n=113 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Temperature Increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Tachycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Bradycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Hypertension (systolic)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Hypertension (diastolic)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Hypotension (systolic)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Respiratory Rate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 Participants
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).
|
Stage 2, Group 2 Older Adults, ASP3772 Low Dose
n=100 Participants
Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2 Older Adults, ASP3772 Medium Dose
n=107 Participants
Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1
|
Stage 2, Group 2 Older Adults, ASP3772 High Dose
n=86 Participants
Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2, PCV13 Pooled Comparator
n=97 Participants
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 3, PPSV23 Comparator
n=113 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Values
Total Bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Values
Alkaline phosphatase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 Participants
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).
|
Stage 2, Group 2 Older Adults, ASP3772 Low Dose
n=100 Participants
Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2 Older Adults, ASP3772 Medium Dose
n=107 Participants
Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1
|
Stage 2, Group 2 Older Adults, ASP3772 High Dose
n=86 Participants
Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2, PCV13 Pooled Comparator
n=97 Participants
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 3, PPSV23 Comparator
n=113 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Physical Examination Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 Participants
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).
|
Stage 2, Group 2 Older Adults, ASP3772 Low Dose
n=98 Participants
Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2 Older Adults, ASP3772 Medium Dose
n=107 Participants
Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1
|
Stage 2, Group 2 Older Adults, ASP3772 High Dose
n=76 Participants
Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2, PCV13 Pooled Comparator
n=92 Participants
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 3, PPSV23 Comparator
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 7Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 Participants
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).
|
Stage 2, Group 2 Older Adults, ASP3772 Low Dose
n=95 Participants
Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2 Older Adults, ASP3772 Medium Dose
n=106 Participants
Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1
|
Stage 2, Group 2 Older Adults, ASP3772 High Dose
n=86 Participants
Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2, PCV13 Pooled Comparator
n=93 Participants
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 3, PPSV23 Comparator
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=108 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
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.
|
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.
|
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 2, Group 3]
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Local reactions include pain, tenderness, redness/erythema, swelling and induration.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1]
Tenderness
|
15 Participants
|
22 Participants
|
20 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1]
Pain
|
16 Participants
|
19 Participants
|
20 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1]
Induration
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1]
Erythema/Redness
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1]
Swelling
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Assessed solicited local reactions were pain, tenderness, redness/erythema, swelling, induration, itching at injection site and pruritus at injection site.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=100 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=107 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=86 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=97 Participants
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).
|
Stage 2, Group 2 Older Adults, ASP3772 Low Dose
n=113 Participants
Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3]
Tenderness
|
38 Participants
|
51 Participants
|
48 Participants
|
42 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3]
Pain
|
26 Participants
|
37 Participants
|
38 Participants
|
33 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3]
Induration
|
2 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3]
Erythema/Redness
|
1 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3]
Swelling
|
1 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
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
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]
Fatigue
|
7 Participants
|
8 Participants
|
10 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]
Myalgia
|
7 Participants
|
7 Participants
|
11 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]
Headache
|
5 Participants
|
6 Participants
|
7 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]
Diarrhea
|
4 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]
Nausea
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]
Fever
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]
Vomiting
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=100 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=107 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=86 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=97 Participants
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).
|
Stage 2, Group 2 Older Adults, ASP3772 Low Dose
n=113 Participants
Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]
Headache
|
13 Participants
|
12 Participants
|
10 Participants
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]
Myalgia
|
11 Participants
|
26 Participants
|
27 Participants
|
17 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]
Fatigue
|
18 Participants
|
18 Participants
|
22 Participants
|
21 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]
Diarrhea
|
3 Participants
|
15 Participants
|
13 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]
Arthralgia
|
5 Participants
|
10 Participants
|
13 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]
Nausea
|
4 Participants
|
9 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]
Vomiting
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1 and Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=29 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 1, Day 1
|
7.5 Titers
Interval 5.2 to 10.7
|
7.6 Titers
Interval 5.3 to 10.9
|
7.7 Titers
Interval 5.6 to 10.6
|
6.5 Titers
Interval 4.6 to 9.2
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 1, Day 30
|
448.4 Titers
Interval 298.4 to 673.7
|
347.0 Titers
Interval 239.0 to 503.7
|
337.6 Titers
Interval 204.4 to 557.7
|
482.1 Titers
Interval 295.1 to 787.5
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 3, Day 1
|
33.5 Titers
Interval 17.7 to 63.4
|
43.6 Titers
Interval 22.2 to 85.5
|
14.4 Titers
Interval 8.3 to 24.9
|
21.4 Titers
Interval 12.0 to 37.9
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 3, Day 30
|
368.1 Titers
Interval 276.2 to 490.6
|
485.7 Titers
Interval 394.1 to 598.6
|
432.6 Titers
Interval 306.4 to 610.7
|
337.7 Titers
Interval 221.1 to 515.8
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 4, Day 1
|
46.8 Titers
Interval 15.9 to 137.2
|
29.4 Titers
Interval 11.5 to 75.7
|
77.1 Titers
Interval 29.7 to 200.2
|
42.2 Titers
Interval 16.0 to 111.5
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 4, Day 30
|
4038.7 Titers
Interval 3141.8 to 5191.8
|
2452.8 Titers
Interval 1359.9 to 4424.1
|
5211.8 Titers
Interval 3483.0 to 7798.7
|
4912.1 Titers
Interval 3183.9 to 7578.3
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 5, Day 1
|
12.5 Titers
Interval 5.7 to 27.5
|
8.0 Titers
Interval 4.9 to 13.0
|
6.1 Titers
Interval 4.4 to 8.5
|
6.6 Titers
Interval 4.0 to 10.7
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 5, Day 30
|
1344.0 Titers
Interval 930.1 to 1942.0
|
1193.9 Titers
Interval 675.3 to 2110.9
|
1557.3 Titers
Interval 1092.0 to 2220.9
|
1954.8 Titers
Interval 1337.9 to 2856.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 6A, Day1
|
64.3 Titers
Interval 26.4 to 156.7
|
55.8 Titers
Interval 26.4 to 118.2
|
78.6 Titers
Interval 32.7 to 188.7
|
76.5 Titers
Interval 32.5 to 180.2
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 6A, Day 30
|
9817.6 Titers
Interval 6133.9 to 15713.3
|
6018.5 Titers
Interval 3213.3 to 11272.6
|
6953.5 Titers
Interval 4675.5 to 10341.6
|
18733.9 Titers
Interval 12189.2 to 28792.5
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 6B, Day 1
|
110.1 Titers
Interval 39.8 to 304.9
|
119.8 Titers
Interval 56.3 to 255.0
|
65.7 Titers
Interval 32.7 to 131.7
|
92.3 Titers
Interval 38.1 to 223.4
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 6B, Day 30
|
7742.8 Titers
Interval 5776.7 to 10378.0
|
4981.0 Titers
Interval 3211.1 to 7726.5
|
4720.9 Titers
Interval 3214.1 to 6934.0
|
10986.7 Titers
Interval 7116.4 to 16962.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 7F, Day 1
|
1003.2 Titers
Interval 392.4 to 2565.0
|
422.8 Titers
Interval 171.1 to 1044.9
|
412.5 Titers
Interval 154.5 to 1101.2
|
1325.5 Titers
Interval 790.4 to 2222.7
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 7F, Day 30
|
7185.5 Titers
Interval 5104.6 to 10114.7
|
6025.6 Titers
Interval 4913.8 to 7388.9
|
7223.4 Titers
Interval 5417.6 to 9631.0
|
8855.7 Titers
Interval 6388.9 to 12274.9
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 9V, Day 1
|
1106.5 Titers
Interval 605.1 to 2023.5
|
279.4 Titers
Interval 107.4 to 727.2
|
360.9 Titers
Interval 156.0 to 834.8
|
577.6 Titers
Interval 268.2 to 1243.8
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 9V, Day 30
|
8458.4 Titers
Interval 5783.2 to 12371.0
|
7789.6 Titers
Interval 5051.3 to 12012.4
|
10532.3 Titers
Interval 7817.6 to 14189.7
|
13756.2 Titers
Interval 8965.1 to 21107.5
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 14, Day 1
|
592.9 Titers
Interval 257.1 to 1367.2
|
269.7 Titers
Interval 111.8 to 650.8
|
138.2 Titers
Interval 45.4 to 421.0
|
141.1 Titers
Interval 51.6 to 385.7
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 14, Day 30
|
5407.3 Titers
Interval 3328.8 to 8783.7
|
2805.5 Titers
Interval 1161.4 to 6776.9
|
11292.9 Titers
Interval 6725.4 to 18962.5
|
9982.6 Titers
Interval 6004.5 to 16596.4
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 18C, Day 1
|
74.7 Titers
Interval 28.8 to 193.8
|
119.3 Titers
Interval 53.4 to 266.5
|
123.0 Titers
Interval 54.0 to 280.5
|
100.6 Titers
Interval 42.3 to 239.2
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 18C, Day 30
|
6779.7 Titers
Interval 4488.1 to 10241.5
|
5266.3 Titers
Interval 3253.8 to 8523.6
|
6077.0 Titers
Interval 4315.7 to 8557.2
|
7592.1 Titers
Interval 5455.2 to 10565.9
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 19A, Day 1
|
732.8 Titers
Interval 411.7 to 1304.1
|
469.0 Titers
Interval 250.3 to 878.9
|
489.9 Titers
Interval 306.7 to 782.6
|
657.8 Titers
Interval 374.3 to 1156.1
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 19A, Day 30
|
3879.0 Titers
Interval 2750.8 to 5469.8
|
5357.2 Titers
Interval 3802.0 to 7548.5
|
4866.3 Titers
Interval 3601.4 to 6575.5
|
7695.1 Titers
Interval 5705.5 to 10378.5
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 19F, Day 1
|
221.4 Titers
Interval 93.2 to 525.9
|
391.4 Titers
Interval 176.2 to 869.3
|
457.9 Titers
Interval 247.7 to 846.5
|
316.0 Titers
Interval 157.1 to 635.6
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 19F, Day 30
|
3397.2 Titers
Interval 2572.4 to 4486.4
|
3862.5 Titers
Interval 2682.0 to 5562.7
|
5636.2 Titers
Interval 4136.8 to 7679.0
|
6065.2 Titers
Interval 3976.2 to 9251.5
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 23F, Day 1
|
230.6 Titers
Interval 71.3 to 745.7
|
141.0 Titers
Interval 49.4 to 402.4
|
69.9 Titers
Interval 24.0 to 203.9
|
103.9 Titers
Interval 33.9 to 318.5
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Serotype 23F, Day 30
|
2947.8 Titers
Interval 1490.1 to 5831.7
|
2951.1 Titers
Interval 1464.8 to 5945.5
|
3399.7 Titers
Interval 1569.3 to 7364.7
|
15054.3 Titers
Interval 8573.2 to 26435.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1 and Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 6B, Day 30
|
14638.6 Titers
Interval 8712.2 to 24596.4
|
8728.4 Titers
Interval 4656.8 to 16360.1
|
10206.8 Titers
Interval 6083.2 to 17125.7
|
11576.4 Titers
Interval 6130.6 to 21860.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 7F, Day 1
|
305.8 Titers
Interval 170.1 to 549.7
|
234.5 Titers
Interval 164.0 to 335.4
|
342.6 Titers
Interval 230.0 to 510.2
|
202.8 Titers
Interval 137.9 to 298.3
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 1, Day 1
|
190.4 Titers
Interval 110.0 to 329.8
|
177.2 Titers
Interval 109.8 to 285.9
|
252.8 Titers
Interval 156.1 to 409.3
|
177.1 Titers
Interval 107.0 to 293.1
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 1, Day 30
|
5174.8 Titers
Interval 3459.5 to 7740.6
|
7023.9 Titers
Interval 4786.0 to 10308.2
|
11097.1 Titers
Interval 7934.9 to 15519.5
|
7407.4 Titers
Interval 4595.0 to 11941.2
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 3, Day 1
|
103.7 Titers
Interval 57.3 to 187.6
|
135.9 Titers
Interval 92.4 to 199.9
|
101.6 Titers
Interval 70.6 to 146.3
|
82.2 Titers
Interval 50.3 to 134.1
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 3, Day 30
|
755.8 Titers
Interval 519.3 to 1100.0
|
1465.6 Titers
Interval 1088.8 to 1972.8
|
2115.7 Titers
Interval 1571.6 to 2848.1
|
547.0 Titers
Interval 386.4 to 774.2
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 4, Day 1
|
85.6 Titers
Interval 50.5 to 144.8
|
68.5 Titers
Interval 39.8 to 117.9
|
103.2 Titers
Interval 61.4 to 173.6
|
83.4 Titers
Interval 48.4 to 143.7
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 4, Day 30
|
2709.5 Titers
Interval 1827.5 to 4017.3
|
2171.4 Titers
Interval 1508.5 to 3125.6
|
4778.6 Titers
Interval 3114.7 to 7331.4
|
2129.3 Titers
Interval 1348.0 to 3363.4
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 5, Day 1
|
194.6 Titers
Interval 101.5 to 373.2
|
82.0 Titers
Interval 50.8 to 132.2
|
105.5 Titers
Interval 67.4 to 165.0
|
113.8 Titers
Interval 66.6 to 194.7
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 5, Day 30
|
7426.7 Titers
Interval 4829.4 to 11420.8
|
3946.3 Titers
Interval 2228.0 to 6989.8
|
6973.3 Titers
Interval 4416.2 to 11011.0
|
4691.0 Titers
Interval 2318.4 to 9491.4
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 6A, Day 1
|
192.8 Titers
Interval 115.3 to 322.5
|
206.8 Titers
Interval 134.6 to 317.7
|
175.9 Titers
Interval 106.8 to 289.6
|
161.5 Titers
Interval 92.0 to 283.6
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 6A, Day 30
|
8735.6 Titers
Interval 5103.5 to 14952.5
|
7585.4 Titers
Interval 4028.4 to 14283.4
|
6805.0 Titers
Interval 4084.3 to 11338.0
|
9819.2 Titers
Interval 5487.6 to 17569.8
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 6B, Day 1
|
199.6 Titers
Interval 99.5 to 400.4
|
155.9 Titers
Interval 93.0 to 261.3
|
130.7 Titers
Interval 82.7 to 206.6
|
162.4 Titers
Interval 86.2 to 305.9
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 7F, Day 30
|
7131.3 Titers
Interval 4960.4 to 10252.4
|
7580.7 Titers
Interval 5169.8 to 11115.9
|
11037.5 Titers
Interval 7653.3 to 15918.1
|
3830.9 Titers
Interval 2423.0 to 6056.8
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 9V, Day 1
|
152.7 Titers
Interval 90.7 to 257.0
|
104.2 Titers
Interval 73.2 to 148.3
|
119.4 Titers
Interval 85.1 to 167.6
|
139.9 Titers
Interval 84.8 to 230.7
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 9V, Day 30
|
3791.8 Titers
Interval 2479.8 to 5797.8
|
5523.5 Titers
Interval 3890.7 to 7841.4
|
6681.5 Titers
Interval 4440.9 to 10052.6
|
3968.6 Titers
Interval 2312.1 to 6811.7
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 14, Day 1
|
837.6 Titers
Interval 423.6 to 1656.1
|
1062.2 Titers
Interval 582.1 to 1938.4
|
363.8 Titers
Interval 186.7 to 708.9
|
408.7 Titers
Interval 224.0 to 745.7
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 14, Day 30
|
16115.3 Titers
Interval 8502.1 to 30545.5
|
17185.4 Titers
Interval 9582.7 to 30820.1
|
33150.4 Titers
Interval 18372.0 to 59816.3
|
15893.1 Titers
Interval 8049.8 to 31378.2
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 18C, Day 1
|
282.4 Titers
Interval 151.5 to 526.4
|
221.1 Titers
Interval 144.7 to 337.8
|
258.3 Titers
Interval 149.1 to 447.3
|
206.0 Titers
Interval 121.1 to 350.6
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 18C, Day 30
|
6975.0 Titers
Interval 4497.5 to 10817.4
|
6435.2 Titers
Interval 4221.1 to 9810.6
|
6911.0 Titers
Interval 4397.8 to 10860.5
|
6405.1 Titers
Interval 3931.0 to 10436.3
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 19A, Day 1
|
937.2 Titers
Interval 507.7 to 1730.0
|
484.6 Titers
Interval 298.1 to 787.8
|
581.6 Titers
Interval 339.7 to 995.8
|
582.8 Titers
Interval 354.0 to 959.6
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 19A, Day 30
|
6568.1 Titers
Interval 4520.8 to 9580.6
|
8343.0 Titers
Interval 4962.4 to 14026.8
|
8461.9 Titers
Interval 5175.4 to 13835.4
|
9721.7 Titers
Interval 6666.3 to 14177.5
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 19F, Day 1
|
498.4 Titers
Interval 263.2 to 943.7
|
477.2 Titers
Interval 272.1 to 836.9
|
380.5 Titers
Interval 232.2 to 623.3
|
340.1 Titers
Interval 192.6 to 600.5
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 19F, Day 30
|
7144.4 Titers
Interval 4342.7 to 11753.5
|
9886.9 Titers
Interval 7035.8 to 13893.5
|
10142.9 Titers
Interval 5870.0 to 17526.0
|
7176.5 Titers
Interval 4272.9 to 12053.2
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 23F, Day 1
|
254.2 Titers
Interval 145.0 to 445.7
|
236.4 Titers
Interval 156.9 to 356.4
|
230.0 Titers
Interval 122.4 to 432.0
|
251.6 Titers
Interval 154.6 to 409.4
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Serotype 23F, Day 30
|
5338.2 Titers
Interval 3015.8 to 9448.9
|
5759.0 Titers
Interval 3467.1 to 9565.8
|
7435.0 Titers
Interval 4423.9 to 12495.6
|
11580.6 Titers
Interval 6105.4 to 21965.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=32 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Serotype 2
|
29.7 fold rise
Interval 18.1 to 49.0
|
34.5 fold rise
Interval 19.7 to 60.4
|
66.5 fold rise
Interval 40.3 to 109.6
|
1.2 fold rise
Interval 1.1 to 1.3
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Serotype 8
|
35.8 fold rise
Interval 20.3 to 63.4
|
57.7 fold rise
Interval 34.6 to 96.2
|
102.7 fold rise
Interval 62.2 to 169.5
|
1.3 fold rise
Interval 1.0 to 1.7
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Serotype 9N
|
32.3 fold rise
Interval 19.8 to 52.6
|
39.5 fold rise
Interval 23.6 to 66.1
|
51.6 fold rise
Interval 29.0 to 91.7
|
3.5 fold rise
Interval 2.4 to 5.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Serotype 10A
|
14.8 fold rise
Interval 9.7 to 22.6
|
10.0 fold rise
Interval 6.6 to 15.0
|
16.2 fold rise
Interval 10.9 to 24.2
|
1.7 fold rise
Interval 1.3 to 2.3
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Serotype 11A
|
6.8 fold rise
Interval 3.9 to 11.9
|
11.2 fold rise
Interval 6.4 to 19.6
|
22.3 fold rise
Interval 15.1 to 33.2
|
1.1 fold rise
Interval 1.0 to 1.1
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Serotype 12F
|
17.1 fold rise
Interval 10.7 to 27.5
|
30.6 fold rise
Interval 19.5 to 47.9
|
31.7 fold rise
Interval 20.1 to 50.2
|
1.5 fold rise
Interval 1.2 to 2.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Serotype 15B
|
16.0 fold rise
Interval 8.4 to 30.5
|
18.7 fold rise
Interval 10.8 to 32.3
|
32.2 fold rise
Interval 17.6 to 58.8
|
1.5 fold rise
Interval 1.1 to 2.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Serotype 17F
|
28.2 fold rise
Interval 16.5 to 48.2
|
48.0 fold rise
Interval 32.6 to 70.7
|
70.4 fold rise
Interval 41.2 to 120.4
|
1.2 fold rise
Interval 1.1 to 1.4
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Serotype 20B
|
7.2 fold rise
Interval 5.0 to 10.5
|
11.4 fold rise
Interval 8.5 to 15.4
|
12.7 fold rise
Interval 8.3 to 19.6
|
1.1 fold rise
Interval 1.0 to 1.3
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Serotype 22F
|
30.4 fold rise
Interval 15.7 to 59.0
|
60.7 fold rise
Interval 30.2 to 122.0
|
52.6 fold rise
Interval 23.2 to 119.4
|
1.1 fold rise
Interval 1.1 to 1.2
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Serotype 33F
|
17.6 fold rise
Interval 11.8 to 26.2
|
37.9 fold rise
Interval 25.7 to 55.7
|
25.5 fold rise
Interval 16.8 to 38.8
|
2.2 fold rise
Interval 1.7 to 2.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=32 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
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
Interval 77.9 to 99.2
|
86.7 Percentage of participants
Interval 69.3 to 96.2
|
96.8 Percentage of participants
Interval 83.3 to 99.9
|
0 Percentage of participants
Interval 0.0 to 10.9
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 77.9 to 99.2
|
96.7 Percentage of participants
Interval 82.8 to 99.9
|
96.8 Percentage of participants
Interval 83.3 to 99.9
|
3.1 Percentage of participants
Interval 0.1 to 16.2
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 77.9 to 99.2
|
90.0 Percentage of participants
Interval 73.5 to 97.9
|
90.3 Percentage of participants
Interval 74.2 to 98.0
|
43.8 Percentage of participants
Interval 26.4 to 62.3
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 73.5 to 97.9
|
83.3 Percentage of participants
Interval 65.3 to 94.4
|
90.3 Percentage of participants
Interval 74.2 to 98.0
|
18.8 Percentage of participants
Interval 7.2 to 36.4
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 37.4 to 74.5
|
70.0 Percentage of participants
Interval 50.6 to 85.3
|
96.8 Percentage of participants
Interval 83.3 to 99.9
|
0 Percentage of participants
Interval 0.0 to 10.9
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 73.5 to 97.9
|
93.3 Percentage of participants
Interval 77.9 to 99.2
|
96.8 Percentage of participants
Interval 83.3 to 99.9
|
6.3 Percentage of participants
Interval 0.8 to 20.8
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 57.7 to 90.1
|
80.0 Percentage of participants
Interval 61.4 to 92.3
|
87.1 Percentage of participants
Interval 70.2 to 96.4
|
3.1 Percentage of participants
Interval 0.1 to 16.2
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 73.5 to 97.9
|
100.0 Percentage of participants
Interval 88.4 to 100.0
|
93.5 Percentage of participants
Interval 78.6 to 99.2
|
3.1 Percentage of participants
Interval 0.1 to 16.2
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 50.6 to 85.3
|
86.7 Percentage of participants
Interval 69.3 to 96.2
|
83.9 Percentage of participants
Interval 66.3 to 94.5
|
0 Percentage of participants
Interval 0.0 to 10.9
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 69.3 to 96.2
|
93.3 Percentage of participants
Interval 77.9 to 99.2
|
80.6 Percentage of participants
Interval 62.5 to 92.5
|
0 Percentage of participants
Interval 0.0 to 10.9
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 73.5 to 97.9
|
100.0 Percentage of participants
Interval 88.4 to 100.0
|
96.8 Percentage of participants
Interval 83.3 to 99.9
|
21.9 Percentage of participants
Interval 9.3 to 40.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 30Population: 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.
Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=29 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=29 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=31 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=31 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Serotype 2
|
5702.0 Titers
Interval 4352.7 to 7469.6
|
5966.2 Titers
Interval 4328.1 to 8224.2
|
6963.2 Titers
Interval 5705.4 to 8498.1
|
177.9 Titers
Interval 70.8 to 447.1
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Serotype 8
|
2122.5 Titers
Interval 1542.8 to 2920.0
|
2000.8 Titers
Interval 1408.2 to 2842.8
|
3254.8 Titers
Interval 2465.2 to 4297.1
|
37.0 Titers
Interval 17.5 to 78.4
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Serotype 9N
|
8525.4 Titers
Interval 6424.8 to 11312.7
|
10826.3 Titers
Interval 6622.7 to 17698.1
|
10215.2 Titers
Interval 7413.7 to 14075.3
|
2856.4 Titers
Interval 1941.7 to 4202.0
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Serotype 10A
|
5542.2 Titers
Interval 3611.7 to 8504.6
|
6094.6 Titers
Interval 3267.7 to 11367.1
|
7764.2 Titers
Interval 5609.5 to 10746.5
|
189.7 Titers
Interval 59.3 to 606.7
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Serotype 11A
|
2020.9 Titers
Interval 1398.4 to 2920.4
|
2034.8 Titers
Interval 1459.3 to 2837.3
|
3195.5 Titers
Interval 2446.0 to 4174.7
|
244.3 Titers
Interval 100.5 to 594.0
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Serotype 12F
|
5536.4 Titers
Interval 3663.1 to 8367.7
|
6501.7 Titers
Interval 4629.6 to 9130.9
|
6630.9 Titers
Interval 5206.3 to 8445.2
|
358.7 Titers
Interval 155.3 to 828.5
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Serotype 15B
|
17128.6 Titers
Interval 9415.4 to 31160.9
|
15042.0 Titers
Interval 8201.1 to 27589.4
|
21608.2 Titers
Interval 12903.6 to 36184.7
|
2497.2 Titers
Interval 1303.0 to 4785.7
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Serotype 17F
|
15011.7 Titers
Interval 9861.1 to 22852.3
|
10352.1 Titers
Interval 7518.3 to 14253.9
|
18396.7 Titers
Interval 12958.7 to 26116.8
|
388.6 Titers
Interval 138.0 to 1094.5
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Serotype 20B
|
17250.5 Titers
Interval 11193.0 to 26586.3
|
37410.1 Titers
Interval 24523.3 to 57068.9
|
36949.9 Titers
Interval 25705.3 to 53113.4
|
1828.6 Titers
Interval 969.2 to 3450.3
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Serotype 22F
|
6897.2 Titers
Interval 4411.0 to 10784.6
|
9221.2 Titers
Interval 5497.3 to 15467.6
|
7085.5 Titers
Interval 4866.3 to 10316.7
|
628.2 Titers
Interval 213.8 to 1846.2
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Serotype 33F
|
13291.8 Titers
Interval 9855.6 to 17926.0
|
16419.1 Titers
Interval 11478.7 to 23485.7
|
21934.8 Titers
Interval 13531.7 to 35556.0
|
647.7 Titers
Interval 257.1 to 1631.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1 and Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=98 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=105 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=85 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=94 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 1, Day 1
|
8.7 Titers
Interval 7.0 to 10.8
|
15.0 Titers
Interval 10.6 to 21.2
|
7.9 Titers
Interval 6.2 to 10.1
|
10.8 Titers
Interval 8.2 to 14.3
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 1, Day 30
|
158.0 Titers
Interval 109.7 to 227.5
|
165.0 Titers
Interval 115.0 to 236.8
|
242.0 Titers
Interval 173.6 to 337.3
|
189.3 Titers
Interval 122.6 to 292.4
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 3, Day 1
|
17.6 Titers
Interval 12.6 to 24.4
|
19.0 Titers
Interval 13.4 to 27.0
|
12.5 Titers
Interval 8.9 to 17.5
|
13.2 Titers
Interval 9.6 to 18.0
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 3, Day 30
|
276.8 Titers
Interval 212.9 to 359.9
|
390.5 Titers
Interval 318.1 to 479.3
|
480.4 Titers
Interval 378.0 to 610.6
|
153.0 Titers
Interval 117.2 to 199.9
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 4, Day 1
|
14.5 Titers
Interval 10.1 to 20.8
|
19.6 Titers
Interval 13.5 to 28.4
|
12.6 Titers
Interval 8.7 to 18.3
|
18.0 Titers
Interval 11.8 to 27.4
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 4, Day 30
|
718.9 Titers
Interval 525.5 to 983.3
|
691.5 Titers
Interval 536.5 to 891.3
|
903.6 Titers
Interval 685.2 to 1191.5
|
732.9 Titers
Interval 492.8 to 1090.1
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 5, Day 1
|
12.8 Titers
Interval 8.8 to 18.7
|
17.2 Titers
Interval 11.5 to 25.7
|
11.4 Titers
Interval 7.6 to 17.2
|
13.0 Titers
Interval 8.9 to 19.0
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 5, Day 30
|
394.6 Titers
Interval 269.4 to 578.1
|
456.1 Titers
Interval 329.9 to 630.4
|
678.9 Titers
Interval 477.7 to 964.7
|
315.1 Titers
Interval 206.5 to 480.8
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 6A, Day 1
|
30.6 Titers
Interval 20.8 to 44.8
|
51.8 Titers
Interval 32.4 to 82.9
|
51.1 Titers
Interval 30.8 to 85.0
|
31.7 Titers
Interval 20.4 to 49.4
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 6A, Day 30
|
1409.7 Titers
Interval 961.9 to 2065.9
|
1834.9 Titers
Interval 1366.6 to 2463.6
|
1900.5 Titers
Interval 1285.5 to 2809.7
|
2045.8 Titers
Interval 1342.3 to 3118.1
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 6B, Day 1
|
79.1 Titers
Interval 50.6 to 123.8
|
82.6 Titers
Interval 52.3 to 130.4
|
84.3 Titers
Interval 50.0 to 142.0
|
71.6 Titers
Interval 43.8 to 117.1
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 6B, Day 30
|
2194.2 Titers
Interval 1552.9 to 3100.4
|
1978.5 Titers
Interval 1510.8 to 2591.0
|
1941.6 Titers
Interval 1433.5 to 2629.7
|
2324.0 Titers
Interval 1686.0 to 3203.5
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 7F, Day 1
|
91.7 Titers
Interval 54.2 to 155.2
|
146.6 Titers
Interval 87.0 to 247.2
|
112.0 Titers
Interval 59.5 to 210.9
|
108.7 Titers
Interval 62.6 to 188.8
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 7F, Day 30
|
2631.4 Titers
Interval 2067.9 to 3348.5
|
2742.0 Titers
Interval 2218.9 to 3388.4
|
3230.9 Titers
Interval 2440.3 to 4277.6
|
3084.0 Titers
Interval 2461.6 to 3863.9
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 9V, Day 1
|
80.7 Titers
Interval 50.2 to 129.7
|
96.6 Titers
Interval 56.7 to 164.5
|
82.0 Titers
Interval 44.1 to 152.8
|
123.7 Titers
Interval 73.0 to 209.6
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 9V, Day 30
|
1715.4 Titers
Interval 1183.3 to 2486.6
|
1453.7 Titers
Interval 1090.8 to 1937.3
|
2503.0 Titers
Interval 1887.8 to 3318.8
|
2060.2 Titers
Interval 1402.9 to 3025.5
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 14, Day 1
|
85.8 Titers
Interval 55.5 to 132.6
|
153.6 Titers
Interval 95.2 to 247.8
|
186.7 Titers
Interval 115.9 to 300.8
|
141.2 Titers
Interval 84.7 to 235.6
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 14, Day 30
|
1912.6 Titers
Interval 1411.8 to 2591.2
|
1273.4 Titers
Interval 917.5 to 1767.2
|
2221.0 Titers
Interval 1594.0 to 3094.7
|
1437.7 Titers
Interval 1009.8 to 2046.8
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 18C, Day 1
|
38.3 Titers
Interval 26.2 to 56.0
|
98.2 Titers
Interval 62.0 to 155.5
|
41.2 Titers
Interval 27.6 to 61.5
|
71.4 Titers
Interval 46.3 to 110.2
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 18C, Day 30
|
1325.5 Titers
Interval 973.0 to 1805.7
|
1461.3 Titers
Interval 1121.2 to 1904.6
|
1951.6 Titers
Interval 1434.1 to 2655.9
|
1483.9 Titers
Interval 1028.2 to 2141.5
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 19A, Day 1
|
128.2 Titers
Interval 87.7 to 187.4
|
193.2 Titers
Interval 131.2 to 284.4
|
141.4 Titers
Interval 93.5 to 213.9
|
167.7 Titers
Interval 112.1 to 250.8
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 19A, Day 30
|
2062.6 Titers
Interval 1635.1 to 2602.0
|
2081.5 Titers
Interval 1665.4 to 2601.6
|
2417.8 Titers
Interval 1810.4 to 3229.0
|
2115.0 Titers
Interval 1652.4 to 2707.1
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 19F, Day 1
|
79.1 Titers
Interval 54.0 to 115.7
|
84.7 Titers
Interval 55.8 to 128.4
|
62.3 Titers
Interval 41.1 to 94.6
|
100.6 Titers
Interval 65.9 to 153.6
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 19F, Day 30
|
1672.1 Titers
Interval 1260.2 to 2218.6
|
1626.9 Titers
Interval 1307.5 to 2024.3
|
2295.5 Titers
Interval 1706.7 to 3087.3
|
1102.6 Titers
Interval 798.0 to 1523.3
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 23F, Day 1
|
26.0 Titers
Interval 17.2 to 39.3
|
32.0 Titers
Interval 20.8 to 49.1
|
27.8 Titers
Interval 17.6 to 43.8
|
23.4 Titers
Interval 16.0 to 34.3
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Serotype 23F, Day 30
|
537.4 Titers
Interval 355.1 to 813.3
|
567.0 Titers
Interval 413.3 to 777.8
|
722.2 Titers
Interval 462.0 to 1128.7
|
800.1 Titers
Interval 494.7 to 1294.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1 and Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=98 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=106 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=86 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=96 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 1, Day 1
|
268.1 Titers
Interval 199.7 to 359.9
|
551.9 Titers
Interval 382.2 to 796.9
|
263.0 Titers
Interval 178.6 to 387.3
|
297.6 Titers
Interval 208.9 to 424.0
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 1, Day 30
|
4510.3 Titers
Interval 3281.4 to 6199.3
|
5730.2 Titers
Interval 4361.3 to 7528.7
|
6436.8 Titers
Interval 4867.6 to 8511.8
|
5510.9 Titers
Interval 3954.4 to 7680.1
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 3, Day 1
|
76.0 Titers
Interval 57.7 to 100.1
|
109.0 Titers
Interval 80.7 to 147.3
|
65.4 Titers
Interval 46.4 to 92.1
|
60.8 Titers
Interval 45.2 to 81.7
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 3, Day 30
|
846.4 Titers
Interval 643.4 to 1113.4
|
1348.7 Titers
Interval 1097.3 to 1657.8
|
1657.6 Titers
Interval 1289.6 to 2130.5
|
409.5 Titers
Interval 316.1 to 530.6
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 4, Day 1
|
128.1 Titers
Interval 99.9 to 164.3
|
183.9 Titers
Interval 134.7 to 250.9
|
105.6 Titers
Interval 82.0 to 136.0
|
158.6 Titers
Interval 114.7 to 219.4
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 4, Day 30
|
1518.9 Titers
Interval 1090.2 to 2116.4
|
1866.0 Titers
Interval 1447.4 to 2405.5
|
2013.4 Titers
Interval 1485.8 to 2728.3
|
1923.5 Titers
Interval 1365.7 to 2709.3
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 5, Day 1
|
175.6 Titers
Interval 121.8 to 253.2
|
258.6 Titers
Interval 178.7 to 374.3
|
163.1 Titers
Interval 107.0 to 248.4
|
162.9 Titers
Interval 114.8 to 231.1
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 5, Day 30
|
3261.2 Titers
Interval 2256.5 to 4713.2
|
3236.7 Titers
Interval 2383.4 to 4395.6
|
4752.5 Titers
Interval 3244.3 to 6961.8
|
2490.5 Titers
Interval 1627.7 to 3810.6
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 6A, Day 1
|
172.0 Titers
Interval 118.0 to 250.9
|
270.9 Titers
Interval 187.5 to 391.5
|
273.4 Titers
Interval 176.4 to 423.9
|
195.6 Titers
Interval 137.4 to 278.4
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 6A, Day 30
|
3132.7 Titers
Interval 2122.1 to 4624.6
|
3850.7 Titers
Interval 2866.6 to 5172.5
|
4438.5 Titers
Interval 3016.6 to 6530.8
|
3640.4 Titers
Interval 2464.8 to 5376.9
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 6B, Day 1
|
162.7 Titers
Interval 112.3 to 235.9
|
291.3 Titers
Interval 193.1 to 439.4
|
221.4 Titers
Interval 140.6 to 348.5
|
139.1 Titers
Interval 94.4 to 205.0
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 6B, Day 30
|
2835.9 Titers
Interval 1906.8 to 4217.9
|
4135.1 Titers
Interval 2913.0 to 5870.0
|
5088.3 Titers
Interval 3384.8 to 7649.1
|
2869.5 Titers
Interval 1900.3 to 4333.0
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 7F, Day 1
|
279.9 Titers
Interval 202.1 to 387.6
|
438.6 Titers
Interval 301.8 to 637.3
|
250.3 Titers
Interval 156.7 to 399.8
|
276.8 Titers
Interval 190.8 to 401.4
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 7F, Day 30
|
5660.9 Titers
Interval 4186.2 to 7655.1
|
5710.7 Titers
Interval 4401.8 to 7408.8
|
6123.2 Titers
Interval 4437.8 to 8448.6
|
3684.2 Titers
Interval 2801.5 to 4845.0
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 9V, Day 1
|
183.6 Titers
Interval 139.7 to 241.4
|
364.5 Titers
Interval 255.1 to 520.9
|
229.1 Titers
Interval 158.9 to 330.4
|
232.6 Titers
Interval 167.5 to 322.9
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 9V, Day 30
|
2990.4 Titers
Interval 2221.0 to 4026.3
|
3798.3 Titers
Interval 2917.8 to 4944.5
|
5006.8 Titers
Interval 3701.4 to 6772.5
|
2316.5 Titers
Interval 1601.7 to 3350.4
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 14, Day 1
|
732.5 Titers
Interval 490.1 to 1095.0
|
1329.0 Titers
Interval 877.6 to 2012.6
|
867.2 Titers
Interval 553.0 to 1360.0
|
997.3 Titers
Interval 639.0 to 1556.6
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 14, Day 30
|
7024.7 Titers
Interval 4809.3 to 10260.8
|
8927.8 Titers
Interval 6494.0 to 12273.7
|
11822.1 Titers
Interval 8177.6 to 17090.8
|
7087.9 Titers
Interval 4885.3 to 10283.5
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 18C, Day 1
|
313.5 Titers
Interval 225.5 to 435.8
|
695.1 Titers
Interval 483.0 to 1000.3
|
354.1 Titers
Interval 228.9 to 547.6
|
454.9 Titers
Interval 315.5 to 655.9
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 18C, Day 30
|
3647.5 Titers
Interval 2598.6 to 5119.8
|
6242.2 Titers
Interval 4764.7 to 8177.8
|
6189.4 Titers
Interval 4553.9 to 8412.3
|
6012.3 Titers
Interval 4479.0 to 8070.6
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 19A, Day 1
|
710.7 Titers
Interval 533.1 to 947.5
|
1157.8 Titers
Interval 820.2 to 1634.4
|
906.3 Titers
Interval 641.7 to 1279.8
|
867.1 Titers
Interval 634.2 to 1185.7
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 19A, Day 30
|
7704.4 Titers
Interval 5669.3 to 10469.9
|
9838.0 Titers
Interval 7745.0 to 12496.7
|
11047.0 Titers
Interval 7767.0 to 15712.0
|
9233.5 Titers
Interval 7068.3 to 12061.9
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 19F, Day 1
|
357.9 Titers
Interval 252.7 to 506.7
|
542.8 Titers
Interval 373.9 to 787.9
|
424.9 Titers
Interval 276.6 to 652.4
|
429.9 Titers
Interval 299.8 to 616.4
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 19F, Day 30
|
5479.0 Titers
Interval 3926.5 to 7645.2
|
7737.1 Titers
Interval 5853.8 to 10226.3
|
10186.4 Titers
Interval 7337.3 to 14141.8
|
4568.2 Titers
Interval 3313.7 to 6297.6
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 23F, Day 1
|
190.8 Titers
Interval 131.4 to 276.9
|
210.7 Titers
Interval 142.5 to 311.6
|
210.7 Titers
Interval 136.7 to 324.7
|
176.5 Titers
Interval 118.7 to 262.3
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Serotype 23F, Day 30
|
2569.9 Titers
Interval 1806.9 to 3655.1
|
2480.7 Titers
Interval 1907.8 to 3225.7
|
3535.7 Titers
Interval 2495.3 to 5010.0
|
2989.8 Titers
Interval 1984.3 to 4504.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=95 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=87 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=70 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=88 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Serotype 33F
|
12.2 fold rise
Interval 9.1 to 16.5
|
10.5 fold rise
Interval 7.5 to 14.7
|
16.7 fold rise
Interval 11.6 to 24.0
|
1.1 fold rise
Interval 1.0 to 1.1
|
—
|
—
|
—
|
—
|
—
|
|
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Serotype 2
|
17.0 fold rise
Interval 12.4 to 23.5
|
12.2 fold rise
Interval 8.5 to 17.5
|
22.6 fold rise
Interval 15.7 to 32.6
|
1.0 fold rise
Interval 1.0 to 1.1
|
—
|
—
|
—
|
—
|
—
|
|
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Serotype 8
|
24.4 fold rise
Interval 17.5 to 34.0
|
18.0 fold rise
Interval 12.3 to 26.3
|
45.7 fold rise
Interval 30.4 to 68.6
|
1.2 fold rise
Interval 1.0 to 1.3
|
—
|
—
|
—
|
—
|
—
|
|
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Serotype 9N
|
19.5 fold rise
Interval 14.1 to 27.0
|
12.4 fold rise
Interval 8.6 to 17.8
|
32.0 fold rise
Interval 22.6 to 45.4
|
2.3 fold rise
Interval 1.9 to 2.8
|
—
|
—
|
—
|
—
|
—
|
|
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Serotype 10A
|
13.9 fold rise
Interval 10.7 to 18.1
|
11.9 fold rise
Interval 8.7 to 16.4
|
19.3 fold rise
Interval 13.7 to 27.1
|
1.1 fold rise
Interval 1.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
|
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Serotype 11A
|
10.5 fold rise
Interval 7.9 to 14.0
|
9.9 fold rise
Interval 7.2 to 13.7
|
18.2 fold rise
Interval 12.8 to 25.9
|
1.1 fold rise
Interval 1.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
|
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Serotype 12F
|
10.6 fold rise
Interval 7.7 to 14.6
|
11.6 fold rise
Interval 8.2 to 16.3
|
14.4 fold rise
Interval 9.7 to 21.5
|
1.1 fold rise
Interval 1.0 to 1.1
|
—
|
—
|
—
|
—
|
—
|
|
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Serotype 15B
|
13.0 fold rise
Interval 9.6 to 17.5
|
9.6 fold rise
Interval 6.8 to 13.6
|
20.3 fold rise
Interval 13.5 to 30.5
|
1.8 fold rise
Interval 1.4 to 2.4
|
—
|
—
|
—
|
—
|
—
|
|
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Serotype 17F
|
26.4 fold rise
Interval 19.5 to 35.6
|
17.1 fold rise
Interval 12.3 to 23.9
|
27.2 fold rise
Interval 18.8 to 39.4
|
1.1 fold rise
Interval 1.0 to 1.1
|
—
|
—
|
—
|
—
|
—
|
|
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Serotype 20B
|
10.1 fold rise
Interval 8.0 to 12.9
|
10.4 fold rise
Interval 7.7 to 13.9
|
15.6 fold rise
Interval 11.8 to 20.8
|
1.1 fold rise
Interval 1.0 to 1.1
|
—
|
—
|
—
|
—
|
—
|
|
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Serotype 22F
|
20.5 fold rise
Interval 14.6 to 28.6
|
16.2 fold rise
Interval 11.2 to 23.3
|
30.5 fold rise
Interval 20.9 to 44.7
|
1.1 fold rise
Interval 1.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=95 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=87 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=70 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=88 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
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
Interval 68.2 to 85.8
|
67.8 Percentage of participants
Interval 56.9 to 77.4
|
81.4 Percentage of participants
Interval 70.3 to 89.7
|
1.1 Percentage of participants
Interval 0.0 to 6.2
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 76.5 to 91.7
|
75.9 Percentage of participants
Interval 65.5 to 84.4
|
87.1 Percentage of participants
Interval 77.0 to 93.9
|
2.3 Percentage of participants
Interval 0.3 to 8.0
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 75.3 to 90.9
|
66.7 Percentage of participants
Interval 55.7 to 76.4
|
87.1 Percentage of participants
Interval 77.0 to 93.9
|
25.0 Percentage of participants
Interval 16.4 to 35.4
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 72.9 to 89.2
|
74.7 Percentage of participants
Interval 64.3 to 83.4
|
85.7 Percentage of participants
Interval 75.3 to 92.9
|
1.1 Percentage of participants
Interval 0.0 to 6.2
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 62.5 to 81.3
|
67.8 Percentage of participants
Interval 56.9 to 77.4
|
84.3 Percentage of participants
Interval 73.6 to 91.9
|
0 Percentage of participants
Interval 0.0 to 4.1
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 55.9 to 75.7
|
72.4 Percentage of participants
Interval 61.8 to 81.5
|
71.4 Percentage of participants
Interval 59.4 to 81.6
|
0 Percentage of participants
Interval 0.0 to 4.1
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 62.5 to 81.3
|
65.5 Percentage of participants
Interval 54.6 to 75.4
|
74.3 Percentage of participants
Interval 62.4 to 84.0
|
17.0 Percentage of participants
Interval 9.9 to 26.6
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 85.4 to 97.0
|
82.8 Percentage of participants
Interval 73.2 to 90.0
|
90.0 Percentage of participants
Interval 80.5 to 95.9
|
0 Percentage of participants
Interval 0.0 to 4.1
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 71.7 to 88.4
|
74.7 Percentage of participants
Interval 64.3 to 83.4
|
84.3 Percentage of participants
Interval 73.6 to 91.9
|
1.1 Percentage of participants
Interval 0.0 to 6.2
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 72.9 to 89.2
|
71.3 Percentage of participants
Interval 60.6 to 80.5
|
90.0 Percentage of participants
Interval 80.5 to 95.9
|
1.1 Percentage of participants
Interval 0.0 to 6.2
|
—
|
—
|
—
|
—
|
—
|
|
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
Interval 65.9 to 84.0
|
66.7 Percentage of participants
Interval 55.7 to 76.4
|
80.0 Percentage of participants
Interval 68.7 to 88.6
|
0 Percentage of participants
Interval 0.0 to 4.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=98 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=105 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=85 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 1, Day 30
|
5.0 ln(titers)
Interval 4.5 to 5.4
|
5.0 ln(titers)
Interval 4.6 to 5.4
|
5.4 ln(titers)
Interval 4.9 to 5.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 2, Day 30
|
7.0 ln(titers)
Interval 6.8 to 7.3
|
6.9 ln(titers)
Interval 6.7 to 7.2
|
7.4 ln(titers)
Interval 7.1 to 7.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 3, Day 30
|
5.6 ln(titers)
Interval 5.4 to 5.9
|
6.0 ln(titers)
Interval 5.7 to 6.2
|
6.2 ln(titers)
Interval 5.9 to 6.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 4, Day 30
|
6.3 ln(titers)
Interval 6.0 to 6.6
|
6.3 ln(titers)
Interval 6.0 to 6.6
|
6.5 ln(titers)
Interval 6.2 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 5, Day 30
|
6.1 ln(titers)
Interval 5.7 to 6.6
|
6.3 ln(titers)
Interval 5.9 to 6.7
|
6.7 ln(titers)
Interval 6.2 to 7.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 6A, Day 30
|
7.2 ln(titers)
Interval 6.7 to 7.6
|
7.4 ln(titers)
Interval 7.0 to 7.8
|
7.5 ln(titers)
Interval 7.0 to 7.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 6B, Day 30
|
7.6 ln(titers)
Interval 7.2 to 8.0
|
7.5 ln(titers)
Interval 7.2 to 7.9
|
7.5 ln(titers)
Interval 7.1 to 7.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 7F, Day 30
|
7.7 ln(titers)
Interval 7.4 to 7.9
|
7.7 ln(titers)
Interval 7.5 to 8.0
|
7.9 ln(titers)
Interval 7.6 to 8.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 8, Day 30
|
7.0 ln(titers)
Interval 6.7 to 7.3
|
7.0 ln(titers)
Interval 6.7 to 7.3
|
7.8 ln(titers)
Interval 7.4 to 8.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 9N, Day 30
|
7.8 ln(titers)
Interval 7.5 to 8.1
|
8.0 ln(titers)
Interval 7.8 to 8.3
|
8.3 ln(titers)
Interval 8.0 to 8.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 9V, Day 30
|
7.5 ln(titers)
Interval 7.1 to 7.8
|
7.3 ln(titers)
Interval 6.9 to 7.6
|
7.8 ln(titers)
Interval 7.4 to 8.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 10A, Day 30
|
7.4 ln(titers)
Interval 7.0 to 7.8
|
7.7 ln(titers)
Interval 7.3 to 8.1
|
7.8 ln(titers)
Interval 7.4 to 8.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 11A, Day 30
|
5.8 ln(titers)
Interval 5.5 to 6.2
|
6.1 ln(titers)
Interval 5.8 to 6.4
|
6.6 ln(titers)
Interval 6.2 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 12F, Day 30
|
7.0 ln(titers)
Interval 6.6 to 7.5
|
6.8 ln(titers)
Interval 6.4 to 7.2
|
7.3 ln(titers)
Interval 6.8 to 7.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 14, Day 30
|
7.3 ln(titers)
Interval 6.9 to 7.7
|
7.0 ln(titers)
Interval 6.6 to 7.3
|
7.5 ln(titers)
Interval 7.1 to 7.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 15B, Day 30
|
8.5 ln(titers)
Interval 8.1 to 8.8
|
8.2 ln(titers)
Interval 7.9 to 8.5
|
8.6 ln(titers)
Interval 8.2 to 9.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 17F, Day 30
|
8.0 ln(titers)
Interval 7.8 to 8.3
|
7.9 ln(titers)
Interval 7.6 to 8.2
|
8.3 ln(titers)
Interval 8.0 to 8.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 18C, Day 30
|
6.9 ln(titers)
Interval 6.5 to 7.2
|
7.0 ln(titers)
Interval 6.7 to 7.3
|
7.3 ln(titers)
Interval 6.9 to 7.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 19A, Day 30
|
7.4 ln(titers)
Interval 7.1 to 7.7
|
7.4 ln(titers)
Interval 7.2 to 7.7
|
7.6 ln(titers)
Interval 7.2 to 7.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 19F, Day 30
|
7.2 ln(titers)
Interval 6.9 to 7.6
|
7.2 ln(titers)
Interval 6.9 to 7.5
|
7.6 ln(titers)
Interval 7.2 to 7.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 22F, Day 30
|
7.4 ln(titers)
Interval 7.1 to 7.7
|
7.3 ln(titers)
Interval 7.0 to 7.6
|
7.6 ln(titers)
Interval 7.2 to 7.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 23F, Day 30
|
6.4 ln(titers)
Interval 5.9 to 6.9
|
6.4 ln(titers)
Interval 6.0 to 6.9
|
6.7 ln(titers)
Interval 6.2 to 7.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 33F, Day 30
|
8.4 ln(titers)
Interval 8.1 to 8.8
|
8.4 ln(titers)
Interval 8.1 to 8.7
|
8.6 ln(titers)
Interval 8.3 to 9.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Serotype 20B, Day 30
|
9.4 ln(titers)
Interval 9.0 to 9.8
|
9.2 ln(titers)
Interval 8.8 to 9.6
|
9.8 ln(titers)
Interval 9.4 to 10.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=98 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=106 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=86 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 17F, Day 30
|
9.0 ln(titers)
Interval 8.7 to 9.3
|
9.2 ln(titers)
Interval 8.9 to 9.5
|
9.4 ln(titers)
Interval 9.1 to 9.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 18C, Day 30
|
8.0 ln(titers)
Interval 7.6 to 8.3
|
8.5 ln(titers)
Interval 8.2 to 8.9
|
8.5 ln(titers)
Interval 8.1 to 8.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 19A, Day 30
|
8.8 ln(titers)
Interval 8.4 to 9.1
|
9.0 ln(titers)
Interval 8.7 to 9.4
|
9.1 ln(titers)
Interval 8.7 to 9.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 19F, Day 30
|
8.5 ln(titers)
Interval 8.1 to 8.9
|
8.9 ln(titers)
Interval 8.5 to 9.2
|
9.1 ln(titers)
Interval 8.8 to 9.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 20B, Day 30
|
6.9 ln(titers)
Interval 6.6 to 7.3
|
7.0 ln(titers)
Interval 6.7 to 7.4
|
7.4 ln(titers)
Interval 7.0 to 7.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 22F, Day 30
|
8.1 ln(titers)
Interval 7.8 to 8.4
|
8.2 ln(titers)
Interval 7.9 to 8.5
|
8.6 ln(titers)
Interval 8.3 to 8.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 23F, Day 30
|
7.8 ln(titers)
Interval 7.4 to 8.2
|
7.8 ln(titers)
Interval 7.4 to 8.1
|
8.1 ln(titers)
Interval 7.7 to 8.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 33F, Day 30
|
9.5 ln(titers)
Interval 9.1 to 9.9
|
9.7 ln(titers)
Interval 9.4 to 10.1
|
9.7 ln(titers)
Interval 9.3 to 10.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 3, Day 30
|
6.8 ln(titers)
Interval 6.5 to 7.1
|
7.2 ln(titers)
Interval 6.9 to 7.5
|
7.4 ln(titers)
Interval 7.1 to 7.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 4, Day 30
|
7.2 ln(titers)
Interval 6.8 to 7.5
|
7.4 ln(titers)
Interval 7.1 to 7.7
|
7.4 ln(titers)
Interval 7.1 to 7.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 5, Day 30
|
8.2 ln(titers)
Interval 7.8 to 8.6
|
8.2 ln(titers)
Interval 7.8 to 8.6
|
8.6 ln(titers)
Interval 8.1 to 9.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 6A, Day 30
|
8.0 ln(titers)
Interval 7.6 to 8.5
|
8.2 ln(titers)
Interval 7.8 to 8.6
|
8.4 ln(titers)
Interval 7.9 to 8.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 1, Day 30
|
8.3 ln(titers)
Interval 8.0 to 8.7
|
8.6 ln(titers)
Interval 8.3 to 8.9
|
8.7 ln(titers)
Interval 8.3 to 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 2, Day 30
|
9.3 ln(titers)
Interval 9.0 to 9.6
|
9.4 ln(titers)
Interval 9.1 to 9.7
|
9.7 ln(titers)
Interval 9.4 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 6B, Day 30
|
8.1 ln(titers)
Interval 7.6 to 8.5
|
8.4 ln(titers)
Interval 8.0 to 8.8
|
8.7 ln(titers)
Interval 8.2 to 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 7F, Day 30
|
8.4 ln(titers)
Interval 8.1 to 8.8
|
8.5 ln(titers)
Interval 8.2 to 8.8
|
8.5 ln(titers)
Interval 8.1 to 8.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 8, Day 30
|
9.0 ln(titers)
Interval 8.8 to 9.3
|
9.1 ln(titers)
Interval 8.9 to 9.4
|
9.7 ln(titers)
Interval 9.4 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 9N, Day 30
|
8.6 ln(titers)
Interval 8.2 to 8.9
|
8.7 ln(titers)
Interval 8.4 to 9.1
|
9.2 ln(titers)
Interval 8.9 to 9.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 9V, Day 30
|
7.9 ln(titers)
Interval 7.6 to 8.3
|
8.2 ln(titers)
Interval 7.9 to 8.5
|
8.4 ln(titers)
Interval 8.1 to 8.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 10A, Day 30
|
9.2 ln(titers)
Interval 8.8 to 9.6
|
9.4 ln(titers)
Interval 9.0 to 9.7
|
9.7 ln(titers)
Interval 9.3 to 10.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 11A, Day 30
|
8.1 ln(titers)
Interval 7.8 to 8.4
|
8.2 ln(titers)
Interval 7.9 to 8.5
|
8.6 ln(titers)
Interval 8.2 to 8.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 12F, Day 30
|
6.4 ln(titers)
Interval 5.9 to 6.9
|
6.6 ln(titers)
Interval 6.1 to 7.0
|
6.6 ln(titers)
Interval 6.1 to 7.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 14, Day 30
|
8.8 ln(titers)
Interval 8.3 to 9.2
|
9.0 ln(titers)
Interval 8.6 to 9.4
|
9.3 ln(titers)
Interval 8.9 to 9.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Serotype 15B, Day 30
|
9.1 ln(titers)
Interval 8.7 to 9.5
|
9.4 ln(titers)
Interval 9.1 to 9.7
|
10.0 ln(titers)
Interval 9.6 to 10.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 30Population: 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.
Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=97 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=105 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=84 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=107 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Serotype 2
|
1506.6 Titers
Interval 1217.8 to 1864.0
|
1323.6 Titers
Interval 1064.8 to 1645.3
|
2130.1 Titers
Interval 1720.8 to 2636.7
|
1012.3 Titers
Interval 779.7 to 1314.2
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Serotype 8
|
1297.6 Titers
Interval 1039.3 to 1620.1
|
1310.5 Titers
Interval 997.2 to 1722.4
|
2792.4 Titers
Interval 2202.5 to 3540.3
|
1342.6 Titers
Interval 1025.0 to 1758.7
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Serotype 9N
|
3200.2 Titers
Interval 2433.1 to 4209.3
|
3814.9 Titers
Interval 3162.7 to 4601.6
|
5279.3 Titers
Interval 4200.6 to 6635.0
|
2362.1 Titers
Interval 1788.1 to 3120.3
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Serotype 10A
|
1958.5 Titers
Interval 1387.7 to 2764.1
|
2574.0 Titers
Interval 1874.3 to 3535.0
|
2912.5 Titers
Interval 1926.3 to 4403.4
|
898.1 Titers
Interval 580.6 to 1389.4
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Serotype 11A
|
427.5 Titers
Interval 322.6 to 566.4
|
509.4 Titers
Interval 400.6 to 647.7
|
872.7 Titers
Interval 657.7 to 1158.0
|
359.5 Titers
Interval 269.7 to 479.3
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Serotype 12F
|
1364.7 Titers
Interval 972.2 to 1915.7
|
1014.9 Titers
Interval 730.3 to 1410.5
|
1712.0 Titers
Interval 1185.4 to 2472.4
|
1133.9 Titers
Interval 775.0 to 1658.9
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Serotype 15B
|
6095.8 Titers
Interval 4420.5 to 8406.1
|
4539.1 Titers
Interval 3479.4 to 5921.4
|
6988.4 Titers
Interval 5235.6 to 9328.0
|
4147.3 Titers
Interval 3039.9 to 5658.3
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Serotype 17F
|
4308.7 Titers
Interval 3335.3 to 5566.2
|
3528.6 Titers
Interval 2820.2 to 4414.9
|
5567.0 Titers
Interval 4337.9 to 7144.3
|
1653.4 Titers
Interval 1154.7 to 2367.5
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Serotype 20B
|
15461.3 Titers
Interval 11110.3 to 21516.4
|
12442.1 Titers
Interval 9136.1 to 16944.4
|
23411.3 Titers
Interval 16037.8 to 34174.7
|
1708.7 Titers
Interval 1215.2 to 2402.7
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Serotype 22F
|
2017.5 Titers
Interval 1479.5 to 2751.2
|
1741.4 Titers
Interval 1331.9 to 2276.9
|
2442.6 Titers
Interval 1888.6 to 3159.0
|
1126.2 Titers
Interval 759.6 to 1669.9
|
—
|
—
|
—
|
—
|
—
|
|
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Serotype 33F
|
6822.7 Titers
Interval 4904.1 to 9491.9
|
6265.0 Titers
Interval 4847.4 to 8097.3
|
8579.4 Titers
Interval 6421.0 to 11463.2
|
5072.8 Titers
Interval 3729.5 to 6900.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 30Population: 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.
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.
Outcome measures
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=98 Participants
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=106 Participants
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=86 Participants
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=110 Participants
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).
|
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.
|
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
|
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.
|
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 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.
|
|---|---|---|---|---|---|---|---|---|---|
|
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Serotype 2
|
12372.5 Titers
Interval 9734.3 to 15725.7
|
13002.6 Titers
Interval 9984.9 to 16932.5
|
18046.8 Titers
Interval 14062.8 to 23159.5
|
9152.0 Titers
Interval 6999.2 to 11966.8
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Serotype 8
|
9677.9 Titers
Interval 7671.1 to 12209.7
|
10169.1 Titers
Interval 7940.9 to 13022.6
|
19090.8 Titers
Interval 15224.8 to 23938.5
|
6416.8 Titers
Interval 4968.2 to 8287.6
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Serotype 9N
|
5768.2 Titers
Interval 4408.9 to 7546.6
|
6616.2 Titers
Interval 4919.6 to 8897.8
|
10826.9 Titers
Interval 8103.3 to 14465.7
|
3619.7 Titers
Interval 2761.6 to 4744.5
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Serotype 10A
|
10809.8 Titers
Interval 7891.5 to 14807.3
|
12474.3 Titers
Interval 8946.9 to 17392.2
|
17483.9 Titers
Interval 12026.3 to 25418.2
|
4815.5 Titers
Interval 3557.3 to 6518.8
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Serotype 11A
|
4445.2 Titers
Interval 3442.1 to 5740.5
|
4602.5 Titers
Interval 3584.5 to 5909.6
|
6928.5 Titers
Interval 5266.2 to 9115.4
|
2423.4 Titers
Interval 1857.6 to 3161.4
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Serotype 12F
|
556.1 Titers
Interval 382.8 to 808.0
|
675.3 Titers
Interval 462.1 to 986.8
|
696.8 Titers
Interval 441.3 to 1100.1
|
424.4 Titers
Interval 290.2 to 620.5
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Serotype 15B
|
9320.5 Titers
Interval 6869.4 to 12646.0
|
12611.9 Titers
Interval 9628.3 to 16520.1
|
22041.9 Titers
Interval 15842.8 to 30666.5
|
7515.1 Titers
Interval 5496.3 to 10275.5
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Serotype 17F
|
9259.1 Titers
Interval 6977.1 to 12287.6
|
11508.5 Titers
Interval 9042.1 to 14647.5
|
14067.7 Titers
Interval 10377.3 to 19070.6
|
3517.3 Titers
Interval 2520.6 to 4908.1
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Serotype 20B
|
863.3 Titers
Interval 646.3 to 1153.1
|
991.4 Titers
Interval 741.0 to 1326.5
|
1355.5 Titers
Interval 979.5 to 1875.8
|
355.3 Titers
Interval 264.0 to 478.2
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Serotype 22F
|
3385.1 Titers
Interval 2624.9 to 4365.5
|
3577.6 Titers
Interval 2755.1 to 4645.6
|
5462.2 Titers
Interval 4218.3 to 7072.9
|
1359.0 Titers
Interval 1018.7 to 1813.1
|
—
|
—
|
—
|
—
|
—
|
|
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Serotype 33F
|
15822.1 Titers
Interval 11471.2 to 21823.3
|
19432.8 Titers
Interval 14796.7 to 25521.3
|
19959.6 Titers
Interval 14321.7 to 27817.0
|
9459.6 Titers
Interval 7222.2 to 12390.2
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Stage 1, Group 1 Adults, ASP3772 Low Dose
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Stage 1, Group 1 Adults, ASP3772 Medium Dose
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Stage 1, Group 1 Adults, ASP3772 High Dose
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Stage 1, Group 1, PCV13 Pooled Comparator
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Stage 2, Group 2 Older Adults, ASP3772 Low Dose
Serious events: 4 serious events
Other events: 56 other events
Deaths: 0 deaths
Stage 2, Group 2 Older Adults, ASP3772 Medium Dose
Serious events: 5 serious events
Other events: 68 other events
Deaths: 1 deaths
Stage 2, Group 2 Older Adults, ASP3772 High Dose
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
Stage 2, Group 2, PCV13 Pooled Comparator
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Stage 2, Group 3, PPSV23 Comparator
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 participants at risk
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 participants at risk
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 participants at risk
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 participants at risk
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).
|
Stage 2, Group 2 Older Adults, ASP3772 Low Dose
n=100 participants at risk
Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2 Older Adults, ASP3772 Medium Dose
n=107 participants at risk
Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2 Older Adults, ASP3772 High Dose
n=86 participants at risk
Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2, PCV13 Pooled Comparator
n=97 participants at risk
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 3, PPSV23 Comparator
n=113 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.93%
1/107 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Infections and infestations
COVID-19
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.93%
1/107 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.93%
1/107 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.93%
1/107 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.93%
1/107 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
1.0%
1/100 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/107 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
1.0%
1/100 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/107 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/107 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
1.2%
1/86 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
1.0%
1/100 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/107 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
1.0%
1/100 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/107 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.93%
1/107 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
1.0%
1/100 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/107 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
1.0%
1/100 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/107 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.93%
1/107 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.93%
1/107 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.93%
1/107 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
Other adverse events
| Measure |
Stage 1, Group 1 Adults, ASP3772 Low Dose
n=30 participants at risk
Healthy adults aged 18 to 64 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 Medium Dose
n=31 participants at risk
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1 Adults, ASP3772 High Dose
n=32 participants at risk
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 1, Group 1, PCV13 Pooled Comparator
n=33 participants at risk
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).
|
Stage 2, Group 2 Older Adults, ASP3772 Low Dose
n=100 participants at risk
Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2 Older Adults, ASP3772 Medium Dose
n=107 participants at risk
Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2 Older Adults, ASP3772 High Dose
n=86 participants at risk
Healthy older adults aged 65 to 85 years, received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
|
Stage 2, Group 2, PCV13 Pooled Comparator
n=97 participants at risk
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
|
Stage 2, Group 3, PPSV23 Comparator
n=113 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
3.0%
1/33 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/107 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
6.1%
2/33 • Number of events 2 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.93%
1/107 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
1.2%
1/86 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
1.0%
1/97 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.3%
7/30 • Number of events 7 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
22.6%
7/31 • Number of events 7 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
34.4%
11/32 • Number of events 11 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
39.4%
13/33 • Number of events 13 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
11.0%
11/100 • Number of events 11 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
24.3%
26/107 • Number of events 26 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
31.4%
27/86 • Number of events 27 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
17.5%
17/97 • Number of events 17 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Nervous system disorders
Headache
|
20.0%
6/30 • Number of events 6 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
19.4%
6/31 • Number of events 6 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
21.9%
7/32 • Number of events 7 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
39.4%
13/33 • Number of events 14 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
13.0%
13/100 • Number of events 13 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
12.1%
13/107 • Number of events 13 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
11.6%
10/86 • Number of events 10 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
10.3%
10/97 • Number of events 10 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
4/30 • Number of events 4 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
6.5%
2/31 • Number of events 2 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
12.5%
4/32 • Number of events 4 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
18.2%
6/33 • Number of events 6 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
4.0%
4/100 • Number of events 4 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
14.0%
15/107 • Number of events 16 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
15.1%
13/86 • Number of events 13 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
6.2%
6/97 • Number of events 6 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.88%
1/113 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
5.0%
5/100 • Number of events 5 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
9.3%
10/107 • Number of events 10 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
15.1%
13/86 • Number of events 13 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
8.2%
8/97 • Number of events 8 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
Vascular disorders
Hypertension
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/31 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
7.0%
7/100 • Number of events 7 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
5.6%
6/107 • Number of events 6 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
10.5%
9/86 • Number of events 9 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
5.2%
5/97 • Number of events 5 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.88%
1/113 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
General disorders
Fatigue
|
23.3%
7/30 • Number of events 7 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
25.8%
8/31 • Number of events 8 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
31.2%
10/32 • Number of events 10 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
39.4%
13/33 • Number of events 13 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
18.0%
18/100 • Number of events 18 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
16.8%
18/107 • Number of events 18 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
25.6%
22/86 • Number of events 22 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
21.6%
21/97 • Number of events 21 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.88%
1/113 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
General disorders
Injection site erythema
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
6.5%
2/31 • Number of events 2 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
3.1%
1/32 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
9.1%
3/33 • Number of events 3 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
4.0%
4/100 • Number of events 4 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
3.7%
4/107 • Number of events 4 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
7.0%
6/86 • Number of events 6 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
4.1%
4/97 • Number of events 4 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.88%
1/113 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
General disorders
Injection site induration
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
6.5%
2/31 • Number of events 2 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
3.1%
1/32 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
12.1%
4/33 • Number of events 4 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
2.0%
2/100 • Number of events 2 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
5.6%
6/107 • Number of events 6 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
4.7%
4/86 • Number of events 4 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
2.1%
2/97 • Number of events 2 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
General disorders
Injection site pain
|
56.7%
17/30 • Number of events 21 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
77.4%
24/31 • Number of events 26 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
78.1%
25/32 • Number of events 28 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
81.8%
27/33 • Number of events 34 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
41.0%
41/100 • Number of events 47 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
54.2%
58/107 • Number of events 61 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
61.6%
53/86 • Number of events 62 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
47.4%
46/97 • Number of events 52 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.88%
1/113 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
General disorders
Injection site swelling
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
3.2%
1/31 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/32 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
9.1%
3/33 • Number of events 3 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
1.0%
1/100 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
5.6%
6/107 • Number of events 6 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
4.7%
4/86 • Number of events 4 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
4.1%
4/97 • Number of events 4 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/113 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
|
General disorders
Pyrexia
|
0.00%
0/30 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
9.7%
3/31 • Number of events 3 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
3.1%
1/32 • Number of events 1 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/33 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/100 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/107 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/86 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
0.00%
0/97 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
3.5%
4/113 • Number of events 4 • SAEs were collected from Day 1 to Day 180 (study end). Non-serious adverse events collected during 7 days post vaccination.
The analysis was performed on the Safety Analysis Set (SAF) which consisted of all randomized participants who received a vaccination in this study with either ASP3772, PCV13 and PPSV23. Note: for Other Adverse Events Tenderness and Pain solicited events are mapped to 'Injection site pain' as Preferred Term. Hence if the same subject experiences at least once both Tenderness and Pain, he/she will count only once in n.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER