Table 2.
Adverse events after vaccination.
| Adverse events after vaccination with V114 or PCV13 | Adverse events after vaccination with PPSV23 | |||||||
| V114 (n = 152) | PCV13 (n = 150) | V114 (n = 150) | PCV13 (n = 148) | |||||
| n (%) | 95% CI | n (%) | 95% CI | n (%) | 95% CI | n (%) | 95% CI | |
| Any AE | 111 (73.0) | 65.2–79.9 | 94 (62.7) | 54.4–70.4 | 91 (60.7) | 52.4–68.5 | 106 (71.6) | 63.6–78.7 |
| Injection site | 97 (63.8) | 82 (54.7) | 83 (55.3) | 96 (64.9) | ||||
| Systemic | 65 (42.8) | 54 (36.0) | 49 (32.7) | 51 (34.5) | ||||
| Any vaccine-related AE | 101 (66.4) | 58.3–73.9 | 88 (58.7) | 50.3–66.6 | 87 (58.0) | 49.7–66.0 | 99 (66.9) | 58.7–74.4 |
| Injection site | 97 (63.8) | 82 (54.7) | 83 (55.3) | 97 (65.5) | ||||
| Systemic | 40 (26.3) | 36 (24.0) | 34 (22.7) | 36 (24.3) | ||||
| Any SAE | 3 (2.0) | 0.4–5.7 | 0 (0.0) | 0.0–2.4 | 2 (1.3) | 0.2–4.7 | 6 (4.1) | 1.5–8.6 |
| Any vaccine-related SAE | 0 (0.0) | 0.0–2.4 | 0 (0.0) | 0.0–2.4 | 0 (0.0) | 0.0–2.4 | 0 (0.0) | 0.0–2.5 |
| Death | 0 (0.0) | 0.0–2.4 | 0 (0.0) | 0.0–2.4 | 0 (0.0) | 0.0–2.4 | 0 (0.0) | 0.0–2.5 |
| Solicited injection-site AEs (days 1–5) | ||||||||
| Injection-site pain | 87 (57.2) | 49.0–65.2 | 77 (51.3) | 43.0–59.6 | 80 (53.3) | 45.0–61.5 | 91 (61.5) | 53.1–69.4 |
| Injection-site swelling | 18 (11.8) | 7.2–18.1 | 6 (4.0) | 1.5–8.5 | 30 (20.0) | 13.9–27.3 | 43 (29.1) | 21.9–37.1 |
| Injection-site erythema | 7 (4.6) | 1.9–9.3 | 5 (3.3) | 1.1–7.6 | 15 (10.0) | 5.7–16.0 | 18 (12.2) | 7.4–18.5 |
| Solicited systemic AEs (days 1–14) | ||||||||
| Fatigue | 31 (20.4) | 14.3–27.7 | 20 (13.3) | 8.3–19.8 | 19 (12.7) | 7.8–19.1 | 16 (10.8) | 6.3–17.0 |
| Headache | 20 (13.2) | 8.2–19.6 | 14 (9.3) | 5.2–15.2 | 17 (11.3) | 6.7–17.5 | 18 (12.2) | 7.4–18.5 |
| Myalgia | 19 (12.5) | 7.7–18.8 | 14 (9.3) | 5.2–15.2 | 13 (8.7) | 4.7–14.4 | 13 (8.8) | 4.8–14.6 |
| Arthralgia | 5 (3.3) | 1.1–7.5 | 6 (4.0) | 1.5–8.5 | 4 (2.7) | 0.7–6.7 | 2 (1.4) | 0.2–4.8 |
AE, adverse event; CI, confidence interval; PCV13, 13-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal polysaccharide vaccine; SAE, serious AE; V114, 15-valent pneumococcal conjugate vaccine.