Trial Outcomes & Findings for Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years. (NCT NCT04583618)
NCT ID: NCT04583618
Last Updated: 2025-09-08
Results Overview
The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
750 participants
Primary outcome timeframe
Post-vaccination at Day 31
Results posted on
2025-09-08
Participant Flow
This study was conducted at 17 investigational sites in United States between 08 Oct 2020 to 20 Jan 2022.
A total of 750 participants were enrolled in this study.
Participant milestones
| Measure |
Group 1: SP0202-IIb
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single intramuscular (IM) injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
151
|
151
|
149
|
149
|
150
|
|
Overall Study
Safety Analysis Set (SafAS) Population
|
151
|
151
|
148
|
149
|
150
|
|
Overall Study
COMPLETED
|
148
|
148
|
141
|
147
|
148
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
8
|
2
|
2
|
Reasons for withdrawal
| Measure |
Group 1: SP0202-IIb
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single intramuscular (IM) injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol deviation
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
3
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
3
|
1
|
1
|
Baseline Characteristics
Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.
Baseline characteristics by cohort
| Measure |
Group 1: SP0202-IIb
n=151 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=151 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=149 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=149 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=150 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
Total
n=750 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
62.9 Years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
63.4 Years
STANDARD_DEVIATION 6.8 • n=4 Participants
|
63.1 Years
STANDARD_DEVIATION 7.2 • n=21 Participants
|
63.2 Years
STANDARD_DEVIATION 6.8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
417 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
333 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
83 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
120 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
604 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
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
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Post-vaccination at Day 31Population: PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.
The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: SP0202-IIb
n=135 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=143 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=134 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=139 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=136 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 1
|
128 Titer
Interval 92.5 to 177.0
|
127 Titer
Interval 90.3 to 178.0
|
158 Titer
Interval 113.0 to 220.0
|
254 Titer
Interval 183.0 to 353.0
|
289 Titer
Interval 213.0 to 392.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 3
|
136 Titer
Interval 109.0 to 170.0
|
217 Titer
Interval 176.0 to 269.0
|
263 Titer
Interval 214.0 to 323.0
|
157 Titer
Interval 126.0 to 196.0
|
177 Titer
Interval 142.0 to 221.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 4
|
1494 Titer
Interval 1175.0 to 1900.0
|
1306 Titer
Interval 1029.0 to 1658.0
|
2134 Titer
Interval 1675.0 to 2719.0
|
2941 Titer
Interval 2360.0 to 3664.0
|
1873 Titer
Interval 1415.0 to 2480.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 5
|
241 Titer
Interval 166.0 to 349.0
|
230 Titer
Interval 160.0 to 330.0
|
201 Titer
Interval 143.0 to 281.0
|
536 Titer
Interval 378.0 to 760.0
|
377 Titer
Interval 272.0 to 523.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 6A
|
2931 Titer
Interval 2143.0 to 4010.0
|
3074 Titer
Interval 2389.0 to 3957.0
|
2672 Titer
Interval 1923.0 to 3714.0
|
3350 Titer
Interval 2418.0 to 4641.0
|
443 Titer
Interval 288.0 to 681.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 6B
|
3699 Titer
Interval 2857.0 to 4788.0
|
3582 Titer
Interval 2763.0 to 4645.0
|
3479 Titer
Interval 2595.0 to 4664.0
|
5122 Titer
Interval 3916.0 to 6699.0
|
2153 Titer
Interval 1561.0 to 2969.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 7F
|
3487 Titer
Interval 2811.0 to 4326.0
|
2841 Titer
Interval 2262.0 to 3568.0
|
2403 Titer
Interval 1878.0 to 3074.0
|
4253 Titer
Interval 3309.0 to 5466.0
|
2250 Titer
Interval 1721.0 to 2943.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 9V
|
826 Titer
Interval 607.0 to 1123.0
|
828 Titer
Interval 614.0 to 1117.0
|
986 Titer
Interval 700.0 to 1388.0
|
1641 Titer
Interval 1274.0 to 2114.0
|
1159 Titer
Interval 863.0 to 1556.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 14
|
3756 Titer
Interval 2995.0 to 4709.0
|
4407 Titer
Interval 3385.0 to 5737.0
|
3244 Titer
Interval 2421.0 to 4349.0
|
3675 Titer
Interval 2904.0 to 4650.0
|
3999 Titer
Interval 3099.0 to 5161.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 18C
|
905 Titer
Interval 676.0 to 1210.0
|
802 Titer
Interval 590.0 to 1090.0
|
1025 Titer
Interval 756.0 to 1390.0
|
1929 Titer
Interval 1460.0 to 2548.0
|
1177 Titer
Interval 875.0 to 1585.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 19A
|
2067 Titer
Interval 1719.0 to 2485.0
|
3395 Titer
Interval 2796.0 to 4123.0
|
3462 Titer
Interval 2771.0 to 4324.0
|
4417 Titer
Interval 3537.0 to 5515.0
|
2261 Titer
Interval 1841.0 to 2776.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 19F
|
897 Titer
Interval 702.0 to 1145.0
|
1773 Titer
Interval 1406.0 to 2236.0
|
1678 Titer
Interval 1336.0 to 2108.0
|
1525 Titer
Interval 1165.0 to 1997.0
|
983 Titer
Interval 742.0 to 1303.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 23F
|
1999 Titer
Interval 1478.0 to 2704.0
|
1576 Titer
Interval 1153.0 to 2153.0
|
1701 Titer
Interval 1284.0 to 2255.0
|
1792 Titer
Interval 1311.0 to 2450.0
|
488 Titer
Interval 319.0 to 747.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 8
|
1363 Titer
Interval 1110.0 to 1674.0
|
1377 Titer
Interval 1129.0 to 1680.0
|
1486 Titer
Interval 1207.0 to 1829.0
|
74.8 Titer
Interval 52.3 to 107.0
|
2039 Titer
Interval 1664.0 to 2499.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 9N
|
3656 Titer
Interval 2988.0 to 4474.0
|
3858 Titer
Interval 3145.0 to 4733.0
|
4207 Titer
Interval 3430.0 to 5160.0
|
1082 Titer
Interval 806.0 to 1453.0
|
6096 Titer
Interval 4837.0 to 7682.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 10A
|
3501 Titer
Interval 2689.0 to 4557.0
|
2856 Titer
Interval 2190.0 to 3724.0
|
2811 Titer
Interval 2047.0 to 3860.0
|
104 Titer
Interval 64.3 to 167.0
|
3011 Titer
Interval 2060.0 to 4399.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 11A
|
475 Titer
Interval 354.0 to 637.0
|
438 Titer
Interval 324.0 to 594.0
|
318 Titer
Interval 226.0 to 448.0
|
18.3 Titer
Interval 13.0 to 25.6
|
390 Titer
Interval 285.0 to 534.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 12F
|
3492 Titer
Interval 2587.0 to 4714.0
|
3917 Titer
Interval 3116.0 to 4925.0
|
3117 Titer
Interval 2311.0 to 4203.0
|
8.31 Titer
Interval 6.19 to 11.2
|
1345 Titer
Interval 914.0 to 1980.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 15B
|
4930 Titer
Interval 3641.0 to 6677.0
|
4823 Titer
Interval 3588.0 to 6484.0
|
3613 Titer
Interval 2541.0 to 5138.0
|
160 Titer
Interval 112.0 to 230.0
|
3346 Titer
Interval 2409.0 to 4648.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 22F
|
5253 Titer
Interval 4147.0 to 6653.0
|
4639 Titer
Interval 3587.0 to 6001.0
|
4858 Titer
Interval 3683.0 to 6406.0
|
62.5 Titer
Interval 42.4 to 92.1
|
1906 Titer
Interval 1456.0 to 2495.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 33F
|
7313 Titer
Interval 5890.0 to 9078.0
|
8324 Titer
Interval 6488.0 to 10680.0
|
7641 Titer
Interval 6205.0 to 9410.0
|
1201 Titer
Interval 898.0 to 1605.0
|
15082 Titer
Interval 11551.0 to 19692.0
|
PRIMARY outcome
Timeframe: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31Population: PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.
The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.
Outcome measures
| Measure |
Group 1: SP0202-IIb
n=135 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=143 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=134 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=138 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=136 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 1
|
8.40 Ratio
Interval 6.28 to 11.2
|
10.5 Ratio
Interval 7.95 to 14.0
|
9.79 Ratio
Interval 7.15 to 13.4
|
21.3 Ratio
Interval 15.6 to 29.0
|
19.1 Ratio
Interval 14.4 to 25.3
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 3
|
7.06 Ratio
Interval 5.55 to 8.99
|
12.9 Ratio
Interval 10.1 to 16.4
|
13.7 Ratio
Interval 10.7 to 17.4
|
8.52 Ratio
Interval 6.71 to 10.8
|
9.52 Ratio
Interval 7.56 to 12.0
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 4
|
20.7 Ratio
Interval 14.7 to 29.3
|
28.8 Ratio
Interval 20.6 to 40.3
|
33.0 Ratio
Interval 22.2 to 49.2
|
58.9 Ratio
Interval 41.2 to 84.1
|
25.7 Ratio
Interval 18.2 to 36.4
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 5
|
15.2 Ratio
Interval 11.0 to 21.0
|
19.5 Ratio
Interval 14.3 to 26.7
|
12.2 Ratio
Interval 9.1 to 16.4
|
37.4 Ratio
Interval 26.9 to 52.1
|
24.2 Ratio
Interval 18.2 to 32.2
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 6A
|
60.8 Ratio
Interval 42.8 to 86.5
|
69.4 Ratio
Interval 48.3 to 99.8
|
59.2 Ratio
Interval 40.9 to 85.8
|
79.1 Ratio
Interval 54.4 to 115.0
|
9.18 Ratio
Interval 6.34 to 13.3
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 6B
|
29.1 Ratio
Interval 20.6 to 41.2
|
25.7 Ratio
Interval 18.1 to 36.6
|
29.2 Ratio
Interval 19.5 to 43.6
|
49.3 Ratio
Interval 34.8 to 69.7
|
16.6 Ratio
Interval 11.5 to 23.8
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 7F
|
50.8 Ratio
Interval 32.8 to 78.9
|
49.0 Ratio
Interval 32.5 to 73.7
|
24.0 Ratio
Interval 14.9 to 38.7
|
79.1 Ratio
Interval 51.6 to 121.0
|
31.0 Ratio
Interval 21.0 to 45.8
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 9V
|
9.50 Ratio
Interval 7.01 to 12.9
|
9.90 Ratio
Interval 7.2 to 13.6
|
12.7 Ratio
Interval 8.9 to 18.0
|
17.2 Ratio
Interval 12.2 to 24.1
|
10.6 Ratio
Interval 7.78 to 14.4
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 14
|
7.44 Ratio
Interval 5.25 to 10.5
|
14.3 Ratio
Interval 9.69 to 21.0
|
8.44 Ratio
Interval 5.68 to 12.5
|
10.1 Ratio
Interval 7.03 to 14.6
|
9.05 Ratio
Interval 6.46 to 12.7
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 18C
|
17.0 Ratio
Interval 12.4 to 23.3
|
20.6 Ratio
Interval 15.0 to 28.2
|
18.9 Ratio
Interval 13.3 to 27.0
|
43.1 Ratio
Interval 31.1 to 59.8
|
22.1 Ratio
Interval 16.3 to 30.0
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 19A
|
7.36 Ratio
Interval 5.77 to 9.38
|
13.1 Ratio
Interval 10.3 to 16.8
|
11.5 Ratio
Interval 8.66 to 15.3
|
15.5 Ratio
Interval 11.4 to 21.0
|
7.88 Ratio
Interval 6.26 to 9.91
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 19F
|
13.1 Ratio
Interval 9.45 to 18.2
|
30.7 Ratio
Interval 21.9 to 43.0
|
20.8 Ratio
Interval 15.0 to 29.0
|
26.6 Ratio
Interval 19.0 to 37.1
|
17.2 Ratio
Interval 12.5 to 23.7
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 23F
|
45.2 Ratio
Interval 31.0 to 65.9
|
43.0 Ratio
Interval 29.0 to 63.8
|
43.9 Ratio
Interval 29.6 to 65.1
|
45.5 Ratio
Interval 32.2 to 64.4
|
11.6 Ratio
Interval 7.99 to 16.8
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 8
|
18.6 Ratio
Interval 13.5 to 25.6
|
24.1 Ratio
Interval 17.7 to 32.8
|
24.0 Ratio
Interval 16.3 to 35.3
|
1.37 Ratio
Interval 1.14 to 1.65
|
37.6 Ratio
Interval 27.8 to 50.8
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 9N
|
8.90 Ratio
Interval 6.29 to 12.6
|
12.8 Ratio
Interval 8.9 to 18.4
|
11.5 Ratio
Interval 7.88 to 16.8
|
2.84 Ratio
Interval 2.12 to 3.79
|
14.6 Ratio
Interval 10.7 to 20.0
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 10A
|
24.2 Ratio
Interval 16.3 to 35.8
|
24.7 Ratio
Interval 16.5 to 36.9
|
20.8 Ratio
Interval 13.4 to 32.3
|
1.05 Ratio
Interval 0.932 to 1.19
|
22.9 Ratio
Interval 16.1 to 32.7
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 11A
|
14.8 Ratio
Interval 10.4 to 21.0
|
15.9 Ratio
Interval 11.1 to 22.6
|
9.28 Ratio
Interval 6.46 to 13.3
|
0.964 Ratio
Interval 0.786 to 1.18
|
13.7 Ratio
Interval 9.64 to 19.5
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 12F
|
240 Ratio
Interval 163.0 to 354.0
|
252 Ratio
Interval 181.0 to 353.0
|
167 Ratio
Interval 106.0 to 263.0
|
0.975 Ratio
Interval 0.87 to 1.09
|
102 Ratio
Interval 67.7 to 153.0
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 15B
|
30.1 Ratio
Interval 20.8 to 43.6
|
34.3 Ratio
Interval 23.3 to 50.5
|
20.7 Ratio
Interval 14.1 to 30.4
|
1.21 Ratio
Interval 0.997 to 1.47
|
22.8 Ratio
Interval 16.1 to 32.1
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 22F
|
39.0 Ratio
Interval 27.2 to 56.1
|
41.4 Ratio
Interval 28.5 to 60.3
|
38.5 Ratio
Interval 25.4 to 58.3
|
0.878 Ratio
Interval 0.679 to 1.14
|
21.0 Ratio
Interval 15.1 to 29.1
|
|
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Serotype 33F
|
4.21 Ratio
Interval 3.27 to 5.41
|
6.27 Ratio
Interval 4.72 to 8.32
|
4.36 Ratio
Interval 3.45 to 5.52
|
0.931 Ratio
Interval 0.871 to 0.995
|
10.4 Ratio
Interval 7.76 to 13.9
|
PRIMARY outcome
Timeframe: Post-vaccination at Day 31Population: PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.
The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Outcome measures
| Measure |
Group 1: SP0202-IIb
n=137 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=144 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=134 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=139 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=141 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 10A
|
7.16 mcg/mL
Interval 5.37 to 9.55
|
9.48 mcg/mL
Interval 7.1 to 12.6
|
7.37 mcg/mL
Interval 5.39 to 10.1
|
1.06 mcg/mL
Interval 0.84 to 1.35
|
9.11 mcg/mL
Interval 6.83 to 12.1
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 11A
|
4.85 mcg/mL
Interval 3.99 to 5.89
|
4.91 mcg/mL
Interval 4.08 to 5.89
|
4.27 mcg/mL
Interval 3.51 to 5.2
|
0.884 mcg/mL
Interval 0.745 to 1.05
|
3.88 mcg/mL
Interval 3.19 to 4.72
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 12F
|
2.18 mcg/mL
Interval 1.58 to 3.02
|
2.09 mcg/mL
Interval 1.55 to 2.83
|
1.90 mcg/mL
Interval 1.41 to 2.55
|
0.190 mcg/mL
Interval 0.158 to 0.228
|
1.03 mcg/mL
Interval 0.78 to 1.36
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 15B
|
13.4 mcg/mL
Interval 10.5 to 17.2
|
16.3 mcg/mL
Interval 12.8 to 20.8
|
14.8 mcg/mL
Interval 11.7 to 18.8
|
1.84 mcg/mL
Interval 1.42 to 2.39
|
13.6 mcg/mL
Interval 10.8 to 17.2
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 22F
|
3.57 mcg/mL
Interval 2.88 to 4.44
|
4.02 mcg/mL
Interval 3.2 to 5.05
|
3.78 mcg/mL
Interval 3.03 to 4.71
|
0.350 mcg/mL
Interval 0.283 to 0.433
|
2.41 mcg/mL
Interval 1.93 to 3.0
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 33F
|
7.98 mcg/mL
Interval 6.19 to 10.3
|
9.15 mcg/mL
Interval 7.42 to 11.3
|
7.75 mcg/mL
Interval 6.18 to 9.72
|
1.50 mcg/mL
Interval 1.21 to 1.85
|
16.4 mcg/mL
Interval 12.8 to 21.1
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 1
|
2.98 mcg/mL
Interval 2.29 to 3.88
|
3.28 mcg/mL
Interval 2.59 to 4.17
|
4.17 mcg/mL
Interval 3.29 to 5.28
|
5.93 mcg/mL
Interval 4.49 to 7.85
|
7.43 mcg/mL
Interval 5.75 to 9.6
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 3
|
0.746 mcg/mL
Interval 0.616 to 0.903
|
0.977 mcg/mL
Interval 0.818 to 1.17
|
1.22 mcg/mL
Interval 1.01 to 1.49
|
0.899 mcg/mL
Interval 0.738 to 1.1
|
0.858 mcg/mL
Interval 0.717 to 1.03
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 4
|
1.97 mcg/mL
Interval 1.6 to 2.43
|
1.63 mcg/mL
Interval 1.32 to 2.0
|
2.27 mcg/mL
Interval 1.81 to 2.84
|
3.28 mcg/mL
Interval 2.61 to 4.12
|
1.72 mcg/mL
Interval 1.38 to 2.13
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 5
|
2.35 mcg/mL
Interval 1.78 to 3.1
|
2.16 mcg/mL
Interval 1.62 to 2.87
|
2.16 mcg/mL
Interval 1.68 to 2.78
|
4.34 mcg/mL
Interval 3.2 to 5.9
|
3.98 mcg/mL
Interval 3.09 to 5.12
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 6A
|
6.04 mcg/mL
Interval 4.45 to 8.22
|
5.00 mcg/mL
Interval 3.83 to 6.54
|
4.83 mcg/mL
Interval 3.57 to 6.54
|
7.89 mcg/mL
Interval 5.9 to 10.5
|
1.53 mcg/mL
Interval 1.16 to 2.02
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 6B
|
5.73 mcg/mL
Interval 4.17 to 7.89
|
3.62 mcg/mL
Interval 2.66 to 4.93
|
4.37 mcg/mL
Interval 3.22 to 5.95
|
6.45 mcg/mL
Interval 4.92 to 8.45
|
2.47 mcg/mL
Interval 1.86 to 3.28
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 7F
|
6.56 mcg/mL
Interval 5.23 to 8.22
|
5.56 mcg/mL
Interval 4.58 to 6.75
|
5.35 mcg/mL
Interval 4.3 to 6.65
|
10.1 mcg/mL
Interval 8.01 to 12.6
|
4.23 mcg/mL
Interval 3.34 to 5.35
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 9V
|
2.91 mcg/mL
Interval 2.29 to 3.72
|
3.17 mcg/mL
Interval 2.52 to 4.0
|
4.31 mcg/mL
Interval 3.43 to 5.41
|
5.30 mcg/mL
Interval 4.2 to 6.68
|
3.48 mcg/mL
Interval 2.75 to 4.41
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 14
|
12.4 mcg/mL
Interval 9.88 to 15.7
|
10.5 mcg/mL
Interval 8.21 to 13.6
|
9.52 mcg/mL
Interval 7.34 to 12.3
|
10.5 mcg/mL
Interval 8.22 to 13.4
|
14.6 mcg/mL
Interval 11.2 to 19.0
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 18C
|
5.50 mcg/mL
Interval 4.44 to 6.82
|
5.39 mcg/mL
Interval 4.39 to 6.62
|
5.41 mcg/mL
Interval 4.44 to 6.59
|
10.3 mcg/mL
Interval 8.15 to 13.1
|
5.44 mcg/mL
Interval 4.34 to 6.81
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 19A
|
7.41 mcg/mL
Interval 6.03 to 9.1
|
11.7 mcg/mL
Interval 9.16 to 15.1
|
10.9 mcg/mL
Interval 8.41 to 14.2
|
18.3 mcg/mL
Interval 14.4 to 23.2
|
7.59 mcg/mL
Interval 6.05 to 9.52
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 19F
|
3.77 mcg/mL
Interval 2.92 to 4.87
|
8.35 mcg/mL
Interval 6.22 to 11.2
|
7.03 mcg/mL
Interval 5.3 to 9.33
|
9.38 mcg/mL
Interval 7.16 to 12.3
|
4.47 mcg/mL
Interval 3.4 to 5.88
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 23F
|
7.35 mcg/mL
Interval 5.56 to 9.72
|
5.52 mcg/mL
Interval 4.26 to 7.13
|
6.59 mcg/mL
Interval 5.05 to 8.61
|
6.99 mcg/mL
Interval 5.33 to 9.17
|
3.02 mcg/mL
Interval 2.31 to 3.96
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 8
|
7.14 mcg/mL
Interval 5.75 to 8.87
|
6.25 mcg/mL
Interval 5.09 to 7.68
|
6.23 mcg/mL
Interval 4.98 to 7.8
|
0.935 mcg/mL
Interval 0.703 to 1.24
|
9.84 mcg/mL
Interval 8.14 to 11.9
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 9N
|
5.26 mcg/mL
Interval 4.06 to 6.81
|
4.50 mcg/mL
Interval 3.55 to 5.71
|
6.54 mcg/mL
Interval 5.09 to 8.4
|
1.60 mcg/mL
Interval 1.2 to 2.12
|
6.41 mcg/mL
Interval 5.1 to 8.06
|
PRIMARY outcome
Timeframe: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31Population: PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.
The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.
Outcome measures
| Measure |
Group 1: SP0202-IIb
n=137 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=144 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=134 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=139 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=141 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 1
|
5.39 Ratio
Interval 4.33 to 6.7
|
6.47 Ratio
Interval 5.27 to 7.95
|
6.41 Ratio
Interval 5.11 to 8.03
|
11.6 Ratio
Interval 9.21 to 14.6
|
11.5 Ratio
Interval 9.09 to 14.5
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 3
|
2.99 Ratio
Interval 2.49 to 3.61
|
4.02 Ratio
Interval 3.4 to 4.76
|
4.93 Ratio
Interval 4.07 to 5.97
|
3.86 Ratio
Interval 3.21 to 4.65
|
3.52 Ratio
Interval 3.01 to 4.12
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 4
|
6.52 Ratio
Interval 5.32 to 7.98
|
5.91 Ratio
Interval 4.93 to 7.07
|
7.33 Ratio
Interval 5.9 to 9.1
|
10.8 Ratio
Interval 8.71 to 13.3
|
5.47 Ratio
Interval 4.57 to 6.55
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 5
|
5.43 Ratio
Interval 4.32 to 6.82
|
5.81 Ratio
Interval 4.67 to 7.22
|
4.60 Ratio
Interval 3.75 to 5.66
|
10.6 Ratio
Interval 8.15 to 13.7
|
8.93 Ratio
Interval 7.15 to 11.1
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 6A
|
13.8 Ratio
Interval 10.5 to 18.2
|
12.2 Ratio
Interval 9.79 to 15.3
|
12.6 Ratio
Interval 9.76 to 16.4
|
19.3 Ratio
Interval 14.9 to 24.9
|
3.30 Ratio
Interval 2.75 to 3.96
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 6B
|
12.2 Ratio
Interval 9.31 to 16.0
|
9.63 Ratio
Interval 7.59 to 12.2
|
10.7 Ratio
Interval 8.1 to 14.0
|
16.2 Ratio
Interval 12.8 to 20.5
|
5.51 Ratio
Interval 4.51 to 6.74
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 7F
|
10.6 Ratio
Interval 8.37 to 13.4
|
9.67 Ratio
Interval 7.86 to 11.9
|
7.93 Ratio
Interval 6.3 to 9.99
|
16.3 Ratio
Interval 12.8 to 20.7
|
6.80 Ratio
Interval 5.67 to 8.16
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 9V
|
5.65 Ratio
Interval 4.59 to 6.95
|
6.29 Ratio
Interval 5.09 to 7.76
|
7.87 Ratio
Interval 6.28 to 9.86
|
9.12 Ratio
Interval 7.53 to 11.0
|
6.30 Ratio
Interval 5.17 to 7.68
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 14
|
4.91 Ratio
Interval 3.93 to 6.13
|
6.44 Ratio
Interval 5.06 to 8.19
|
4.62 Ratio
Interval 3.59 to 5.95
|
5.96 Ratio
Interval 4.68 to 7.58
|
7.35 Ratio
Interval 5.85 to 9.23
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 18C
|
6.52 Ratio
Interval 5.26 to 8.08
|
7.18 Ratio
Interval 5.86 to 8.79
|
6.21 Ratio
Interval 5.09 to 7.58
|
12.1 Ratio
Interval 9.52 to 15.3
|
6.91 Ratio
Interval 5.74 to 8.31
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 19A
|
4.74 Ratio
Interval 3.89 to 5.78
|
8.76 Ratio
Interval 7.14 to 10.7
|
7.86 Ratio
Interval 6.28 to 9.84
|
12.3 Ratio
Interval 9.79 to 15.4
|
5.74 Ratio
Interval 4.72 to 6.98
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 19F
|
4.97 Ratio
Interval 4.02 to 6.15
|
11.2 Ratio
Interval 8.82 to 14.3
|
9.65 Ratio
Interval 7.53 to 12.4
|
11.2 Ratio
Interval 8.77 to 14.2
|
6.18 Ratio
Interval 5.07 to 7.53
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 23F
|
13.2 Ratio
Interval 10.2 to 17.2
|
11.0 Ratio
Interval 8.75 to 13.9
|
11.9 Ratio
Interval 9.21 to 15.3
|
13.0 Ratio
Interval 10.3 to 16.4
|
5.70 Ratio
Interval 4.57 to 7.12
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 8
|
7.97 Ratio
Interval 6.41 to 9.92
|
8.44 Ratio
Interval 6.88 to 10.3
|
8.20 Ratio
Interval 6.54 to 10.3
|
1.26 Ratio
Interval 1.11 to 1.42
|
13.9 Ratio
Interval 11.5 to 16.8
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 9N
|
6.52 Ratio
Interval 5.22 to 8.14
|
8.39 Ratio
Interval 6.67 to 10.5
|
9.99 Ratio
Interval 7.87 to 12.7
|
2.81 Ratio
Interval 2.36 to 3.35
|
11.3 Ratio
Interval 9.2 to 13.8
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 10A
|
8.45 Ratio
Interval 6.74 to 10.6
|
10.0 Ratio
Interval 8.01 to 12.6
|
7.55 Ratio
Interval 5.83 to 9.78
|
1.15 Ratio
Interval 1.07 to 1.22
|
9.84 Ratio
Interval 7.98 to 12.1
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 11A
|
5.57 Ratio
Interval 4.56 to 6.82
|
6.13 Ratio
Interval 5.08 to 7.38
|
5.36 Ratio
Interval 4.36 to 6.61
|
1.18 Ratio
Interval 1.1 to 1.27
|
5.54 Ratio
Interval 4.65 to 6.6
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 12F
|
8.70 Ratio
Interval 6.66 to 11.4
|
9.47 Ratio
Interval 7.29 to 12.3
|
8.05 Ratio
Interval 6.2 to 10.5
|
1.08 Ratio
Interval 1.02 to 1.14
|
5.07 Ratio
Interval 4.01 to 6.4
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 15B
|
7.77 Ratio
Interval 6.28 to 9.63
|
11.6 Ratio
Interval 9.13 to 14.7
|
8.74 Ratio
Interval 6.99 to 10.9
|
1.35 Ratio
Interval 1.19 to 1.52
|
9.87 Ratio
Interval 7.95 to 12.2
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 22F
|
9.21 Ratio
Interval 7.38 to 11.5
|
10.0 Ratio
Interval 8.09 to 12.5
|
8.99 Ratio
Interval 7.32 to 11.0
|
1.09 Ratio
Interval 1.02 to 1.17
|
7.30 Ratio
Interval 5.95 to 8.95
|
|
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Serotype 33F
|
4.54 Ratio
Interval 3.68 to 5.6
|
5.59 Ratio
Interval 4.58 to 6.81
|
4.43 Ratio
Interval 3.6 to 5.45
|
1.03 Ratio
Interval 0.981 to 1.08
|
9.43 Ratio
Interval 7.64 to 11.6
|
PRIMARY outcome
Timeframe: Within 30 minutes post-vaccinationPopulation: Safety analysis set (SafAS) included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received.
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.
Outcome measures
| Measure |
Group 1: SP0202-IIb
n=151 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=151 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=148 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=149 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=150 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 Days post-vaccination (Day 8)Population: SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Only those participants with data collected for each category at each specified timepoint are reported.
A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site pain, injection site erythema and injection site swelling.
Outcome measures
| Measure |
Group 1: SP0202-IIb
n=149 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=149 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=141 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=146 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=150 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions
Injection site pain
|
106 Participants
|
113 Participants
|
107 Participants
|
85 Participants
|
74 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Injection site erythema
|
17 Participants
|
25 Participants
|
19 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Injection site swelling
|
14 Participants
|
19 Participants
|
14 Participants
|
4 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 7 Days post-vaccination (Day 8)Population: SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Only those participants with data collected for each category at each specified timepoint are reported.
A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia and shivering.
Outcome measures
| Measure |
Group 1: SP0202-IIb
n=149 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=149 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=141 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=146 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=150 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions
Fever
|
3 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache
|
43 Participants
|
47 Participants
|
38 Participants
|
35 Participants
|
41 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Malaise
|
36 Participants
|
43 Participants
|
30 Participants
|
28 Participants
|
32 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia
|
57 Participants
|
71 Participants
|
56 Participants
|
49 Participants
|
65 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Arthralgia
|
23 Participants
|
30 Participants
|
18 Participants
|
17 Participants
|
29 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Shivering
|
20 Participants
|
27 Participants
|
18 Participants
|
7 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Within 30 days post-vaccinationPopulation: SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received.
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination.
Outcome measures
| Measure |
Group 1: SP0202-IIb
n=151 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=151 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=148 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=149 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=150 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs
|
21 Participants
|
34 Participants
|
19 Participants
|
18 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 daysPopulation: SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received.
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. AESI included analyphylaxis.
Outcome measures
| Measure |
Group 1: SP0202-IIb
n=151 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=151 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=148 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=149 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=150 Participants
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
SAEs
|
3 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
AESIs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: SP0202-IIb
Serious events: 3 serious events
Other events: 113 other events
Deaths: 0 deaths
Group 2: SP0202-VI
Serious events: 7 serious events
Other events: 122 other events
Deaths: 1 deaths
Group 3: SP0202-VII
Serious events: 3 serious events
Other events: 112 other events
Deaths: 1 deaths
Group 4: Prevnar 13
Serious events: 2 serious events
Other events: 102 other events
Deaths: 0 deaths
Group 5: Pneumovax 23
Serious events: 2 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: SP0202-IIb
n=151 participants at risk
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=151 participants at risk
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=148 participants at risk
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=149 participants at risk
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=150 participants at risk
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.67%
1/149 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.66%
1/151 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.68%
1/148 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.66%
1/151 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.67%
1/149 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.66%
1/151 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.66%
1/151 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.66%
1/151 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.68%
1/148 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.67%
1/150 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.66%
1/151 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.67%
1/149 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Infections and infestations
Pneumonia Aspiration
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.67%
1/149 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.68%
1/148 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal Squamous Cell Carcinoma
|
0.66%
1/151 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Myeloma
|
0.66%
1/151 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.66%
1/151 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.67%
1/150 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Nervous system disorders
Syncope
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.66%
1/151 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/148 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/151 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.68%
1/148 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/149 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
0.00%
0/150 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
Other adverse events
| Measure |
Group 1: SP0202-IIb
n=151 participants at risk
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.
|
Group 2: SP0202-VI
n=151 participants at risk
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.
|
Group 3: SP0202-VII
n=148 participants at risk
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.
|
Group 4: Prevnar 13
n=149 participants at risk
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.
|
Group 5: Pneumovax 23
n=150 participants at risk
Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.
|
|---|---|---|---|---|---|
|
General disorders
Chills
|
13.2%
20/151 • Number of events 20 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
17.9%
27/151 • Number of events 27 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
12.2%
18/148 • Number of events 18 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
4.7%
7/149 • Number of events 7 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
8.7%
13/150 • Number of events 13 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
General disorders
Injection Site Erythema
|
11.3%
17/151 • Number of events 18 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
16.6%
25/151 • Number of events 25 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
13.5%
20/148 • Number of events 20 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
2.7%
4/149 • Number of events 4 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
6.0%
9/150 • Number of events 10 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
General disorders
Injection Site Pain
|
70.2%
106/151 • Number of events 106 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
74.8%
113/151 • Number of events 113 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
72.3%
107/148 • Number of events 107 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
57.0%
85/149 • Number of events 85 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
49.3%
74/150 • Number of events 74 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
General disorders
Injection Site Swelling
|
9.3%
14/151 • Number of events 15 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
12.6%
19/151 • Number of events 19 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
9.5%
14/148 • Number of events 14 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
2.7%
4/149 • Number of events 4 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
4.0%
6/150 • Number of events 6 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
General disorders
Malaise
|
23.8%
36/151 • Number of events 36 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
28.5%
43/151 • Number of events 43 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
20.3%
30/148 • Number of events 30 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
18.8%
28/149 • Number of events 28 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
21.3%
32/150 • Number of events 32 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
23/151 • Number of events 23 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
19.9%
30/151 • Number of events 30 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
12.2%
18/148 • Number of events 18 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
11.4%
17/149 • Number of events 17 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
20.7%
31/150 • Number of events 31 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
37.7%
57/151 • Number of events 58 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
47.7%
72/151 • Number of events 72 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
37.8%
56/148 • Number of events 56 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
32.9%
49/149 • Number of events 50 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
43.3%
65/150 • Number of events 65 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
|
Nervous system disorders
Headache
|
28.5%
43/151 • Number of events 43 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
31.8%
48/151 • Number of events 51 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
25.7%
38/148 • Number of events 38 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
24.2%
36/149 • Number of events 38 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
28.0%
42/150 • Number of events 44 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.
Analysis was performed on SafAS.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER