|
Kombewa, Kenya
|
Kintampo, Ghana
|
Navrongo, Ghana
|
Overall
|
---|
n
|
PY
|
Value (95% CI)
|
n
|
PY
|
Value (95% CI)
|
n
|
PY
|
Value (95% CI)
|
n
|
PY
|
Value (95% CI)
|
---|
Female
|
N = 1018
|
N = 1786
|
N = 584
|
N = 3388
|
All causes
|
7
|
600
|
1166 (469, 2402)
|
12
|
1154
|
1040 (537, 1817)
|
1
|
374
|
267 (7, 1488)
|
20
|
2129
|
940 (574, 1451)
|
AESI
|
0
|
600
|
0 (0, 614)
|
0
|
1154
|
0 (0, 320)
|
0
|
374
|
0 (0, 985)
|
0
|
2129
|
0 (0, 173)
|
Meningitis
|
0
|
600
|
0 (0, 614)
|
0
|
1154
|
0 (0, 320)
|
0
|
374
|
0 (0, 985)
|
0
|
2129
|
0 (0, 173)
|
Malaria
|
0
|
600
|
0 (0, 614)
|
6
|
1154
|
520 (191, 1132)
|
0
|
374
|
0 (0, 985)
|
6
|
2129
|
282 (103, 614)
|
P. falciparum
|
0
|
600
|
0 (0, 614)
|
1
|
1154
|
87 (2, 483)
|
0
|
374
|
0 (0, 985)
|
1
|
2129
|
47 (1, 262)
|
Other AEs
|
7
|
600
|
1166 (469, 2402)
|
6
|
1154
|
520 (191, 1132)
|
1
|
374
|
267 (7, 1488)
|
14
|
2129
|
658 (360, 1104)
|
Male
|
N = 1093
|
N = 1817
|
N = 599
|
N = 3509
|
All causes
|
14
|
649
|
2157 (1179, 3620)
|
7
|
1176
|
595 (239, 1227)
|
1
|
379
|
264 (7, 1469)
|
22
|
2204
|
998 (626, 1511)
|
AESI
|
0
|
649
|
0 (0, 568)
|
0
|
1176
|
0 (0, 314)
|
0
|
379
|
0 (0, 973)
|
0
|
2204
|
0 (0, 167)
|
Meningitis
|
0
|
649
|
0 (0, 568)
|
0
|
1176
|
0 (0, 314)
|
0
|
379
|
0 (0, 973)
|
0
|
2204
|
0 (0, 167)
|
Malaria
|
3
|
649
|
462 (95, 1351)
|
1
|
1176
|
85 (2, 474)
|
0
|
379
|
0 (0, 973)
|
4
|
2204
|
182 (49, 465)
|
P. falciparum
|
2
|
649
|
308 (37, 1113)
|
1
|
1176
|
85 (2, 474)
|
0
|
379
|
0 (0, 973)
|
3
|
2204
|
136 (28, 398)
|
Other AEs
|
11
|
649
|
1695 (846, 3033)
|
6
|
1176
|
510 (187, 1111)
|
1
|
379
|
264 (7, 1469)
|
18
|
2204
|
817 (484, 1291)
|
Total
|
N = 2111
|
N = 3603
|
N = 1183
|
N = 6897
|
All causes
|
21
|
1249
|
1681 (1041, 2569)
|
19
|
2330
|
816 (491, 1274)
|
2
|
754
|
265 (32, 959)
|
42
|
4332
|
969 (699, 1310)
|
AESI
|
0
|
1249
|
0 (0, 295)
|
0
|
2330
|
0 (0, 158)
|
0
|
754
|
0 (0, 490)
|
0
|
4332
|
0 (0, 85)
|
Meningitis
|
0
|
1249
|
0 (0, 295)
|
0
|
2330
|
0 (0, 158)
|
0
|
754
|
0 (0, 490)
|
0
|
4332
|
0 (0, 85)
|
Malaria
|
3
|
1249
|
240 (50, 702)
|
7
|
2330
|
300 (121, 619)
|
0
|
754
|
0 (0, 490)
|
10
|
4332
|
231 (111, 424)
|
P. falciparum
|
2
|
1249
|
160 (19, 578)
|
2
|
2330
|
86 (10, 310)
|
0
|
754
|
0 (0, 490)
|
4
|
4332
|
92 (25, 236)
|
Other AEs
|
18
|
1249
|
1441 (854, 2277)
|
12
|
2330
|
515 (266, 900)
|
2
|
754
|
265 (32, 959)
|
32
|
4332
|
739 (505, 1043)
|
- According-to-protocol cohort, 5 to 17 months age-group N, Number of study participants at risk during a follow-up period of approximately 6 months after each dose of the virtual primary vaccination schedule censored at the next dose; n, number of cases reported during that follow-up period
- CI: confidence interval; PY: person-years; AE: adverse event; AESI: adverse event of special interest