Table 2.
Unsolicited adverse events in participants in the safety population
| GBS6 5 μg with AlPO4(n=52) | GBS6 5 μg without AlPO4(n=52) | GBS6 10 μg with AlPO4(n=52) | GBS6 10 μg without AlPO4(n=52) | GBS6 20 μg with AlPO4(n=52) | GBS6 20 μg without AlPO4(n=52) | Placebo (n=52) | |
|---|---|---|---|---|---|---|---|
| Any adverse event | 15 (29%; 17–43) | 13 (25%; 14–39) | 22 (42%; 29–57) | 12 (23%; 13–37) | 25 (48%; 34–62) | 21 (40%; 27–55) | 20 (38%; 25–53) |
| Serious adverse event | 1 (2%; 0–10) | 0 (0%; 0–7) | 1 (2%; 0–10) | 0 (0%; 0–7) | 1 (2%; 0–10) | 0 (0%; 0–7) | 0 (0%; 0–7) |
| Immediate adverse event | 0 (0%; 0–7) | 0 (0%; 0–7) | 0 (0%; 0–7) | 0 (0%; 0–7) | 0 (0%; 0–7) | 0 (0%; 0–7) | 0 (0%; 0–7) |
| Severe adverse event | 2 (4%; 1–13) | 2 (4%; 1–13) | 6 (12%; 4–23) | 3 (6%; 1–16) | 2 (4%; 1–13) | 5 (10%; 3–21) | 4 (8%; 2–19) |
| Related adverse event | 2 (4%; 1–13) | 0 (0%; 0–7) | 1 (2%; 0–10) | 1 (2%; 0–10) | 2 (4%; 1–13) | 1 (2%; 0–10) | 0 (0%; 0–7) |
| Medically attended adverse event | 11 (21%; 11–35) | 12 (23·1%; 13–37) | 15 (29%; 17–43) | 10 (19%; 10–33) | 18 (35%; 22–49) | 14 (27%; 16–41) | 18 (35%; 22–49) |
| Adverse event leading to withdrawal | 0 (0%; 0–7) | 0 (0%; 0–7) | 0 (0%; 0–7) | 0 (0%; 0–7) | 0 (0%; 0–7) | 0 (0%; 0–7) | 0 (0%; 0–7) |
Data are n (%; 95% CI). All adverse events reported outside of the electronic diary were recorded in the participant's case report form. Adverse events were reported up to 1 month after vaccination except for serious adverse events and medically attended adverse events, which were reported up to 6 months after vaccination. Participants are counted only once for a specified category. One participant in the 5 μg GBS6 group with AlPO4 had two serious adverse events and is counted only once in this table. AlPO4=aluminium phosphate. GBS6=group B streptococcus-containing vaccine with serotypes Ia, Ib, II, III, IV, and V.