Table 2.
6–35 mo | 3–17 y | 18–60 y | ≥ 61 y | |||||
---|---|---|---|---|---|---|---|---|
(N = 150) |
(N = 150) |
(N = 151) |
(N = 151) |
|||||
Event | n/M | % | n/M | % | n/M | % | n/M | % |
Immediate unsolicited AE | 2/150 | 1.3 | 0/150 | 0.0 | 0/151 | 0.0 | 0/151 | 0.0 |
Vaccine-related | 2/150 | 1.3 | 0/150 | 0.0 | 0/151 | 0.0 | 0/151 | 0.0 |
Solicited reaction | 70/141 | 49.6 | 72/148 | 48.6 | 35/150 | 23.3 | 24/151 | 15.9 |
Solicited injection-site reaction | 33/140 | 23.6 | 53/148 | 35.8 | 26/150 | 17.3 | 13/151 | 8.6 |
Solicited systemic reaction | 60/140 | 42.9 | 39/148 | 26.4 | 16/150 | 10.7 | 14/151 | 9.3 |
Unsolicited AE | 62/150 | 41.3 | 12/150 | 8.0 | 4/151 | 2.6 | 5/151 | 3.3 |
Vaccine-related | 11/150 | 7.3 | 0/150 | 0.0 | 0/151 | 0.0 | 3/151 | 2.0 |
Non-serious | 62/150 | 41.3 | 11/150 | 7.3 | 4/151 | 2.6 | 4/151 | 2.6 |
Non-serious vaccine-related | 11/150 | 7.3 | 0/150 | 0.0 | 0/151 | 0.0 | 3/151 | 2.0 |
Injection-site non-serious vaccine related | 0/150 | 0.0 | 0/150 | 0.0 | 0/151 | 0.0 | 0/151 | 0.0 |
AE leading to study discontinuation | 14/150 | 9.3 | 0/150 | 0.0 | 0/151 | 0.0 | 0/151 | 0.0 |
SAE | 1/150 | 0.7 | 1/150 | 0.7 | 0/151 | 0.0 | 1/151 | 0.7 |
Vaccine-related | 0/150 | 0.0 | 0/150 | 0.0 | 0/151 | 0.0 | 0/151 | 0.0 |
Death | 0/150 | 0.0 | 0/150 | 0.0 | 0/151 | 0.0 | 0/151 | 0.0 |
Abbreviations: AE, adverse event; SAE, serious adverse event