Table 3.
Summary of Adverse Events After Vaccination With PPSV23
| Adverse Event | V114 (n = 1036) | PCV13 (n = 345) | ||||
|---|---|---|---|---|---|---|
| No. | (%) | (95% CI)a | No. | (%) | (95% CI)a | |
| Any AE | 787 | (76.0) | (73.2–78.5) | 264 | (76.5) | (71.7–80.9) |
| Injection-site AEs | 739 | (71.3) | … | 241 | (69.9) | … |
| Systemic AEs | 528 | (51.0) | … | 179 | (51.9) | … |
| Any vaccine-related AEb | 766 | (73.9) | (71.2–76.6) | 250 | (72.5) | (67.4–77.1) |
| Injection-site AEs | 739 | (71.3) | … | 241 | (69.9) | … |
| Systemic AEs | 447 | (43.1) | … | 151 | (43.8) | … |
| Any SAE | 3 | (0.3) | (.1–.8) | 3 | (0.9) | (.2–2.5) |
| Any vaccine-related SAEb | 0 | (0) | (.0–.3) | 1 | (0.3) | (.0–1.6) |
| Deaths | 0 | (0) | (.0–.3) | 0 | (0) | (.0–.9) |
| Solicited injection-site AEs (day 1 to day 5) | ||||||
| Injection-site pain | 713 | (68.8) | (65.9–71.6) | 231 | (67.0) | (61.7–71.9) |
| Injection-site swelling | 305 | (29.4) | (26.7–32.3) | 111 | (32.2) | (27.3–37.4) |
| Injection-site erythema | 234 | (22.6) | (20.1–25.3) | 88 | (25.5) | (21.0–30.5) |
| Solicited systemic AEs (day 1 to day 14) | ||||||
| Fatigue | 312 | (30.1) | (27.3–33.0) | 106 | (30.7) | (25.9–35.9) |
| Myalgia | 250 | (24.1) | (21.6–26.9) | 88 | (25.5) | (21.0–30.5) |
| Headache | 220 | (21.2) | (18.8–23.9) | 73 | (21.2) | (17.0–25.9) |
| Arthralgia | 124 | (12.0) | (10.1–14.1) | 38 | (11.0) | (7.9–14.8) |
Table includes all participants vaccinated with PPSV23. One participant in the PCV13 group incorrectly received V114 and was included in the V114 group for safety analyses. Reported AEs include nonserious AEs within 14 days of vaccination with PPSV23 and SAEs occurring Month 6 (prevaccination with PPSV23) through Month 7 (30 days postvaccination with PPSV23).
Abbreviations: AE, adverse event; CI, confidence interval; PCV13, 13-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal polysaccharide vaccine; SAE, severe adverse event; V114, 15-valent pneumococcal conjugate vaccine.
Estimated Cls are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Deemed related to study vaccine by investigators.