Table 3.
Summary of adverse events following vaccination with V114 or PCV13 by number of risk factors (Day 1–Month 6).
| n (%) | 1 risk factor |
≥2 risk factors |
||
|---|---|---|---|---|
| V114 n = 620 |
PCV13 n = 207 |
V114 n = 229 |
PCV13 n = 75 |
|
| Any AE | 528 (85.2) | 180 (87.0) | 198 (86.5) | 61 (81.3) |
| Injection-site† | 495 (79.8) | 155 (74.9) | 182 (79.5) | 55 (73.3) |
| Systemic | 390 (62.9) | 138 (66.7) | 150 (65.5) | 45 (60.0) |
| Any vaccine-relatedAE‡ | 516 (83.2) | 168 (81.2) | 188 (82.1) | 60 (80.0) |
| Systemic | 309 (49.8) | 101 (48.8) | 114 (49.8) | 34 (45.3) |
| Any SAE | 23 (3.7) | 5 (2.4) | 12 (5.2) | 3 (4.0) |
| Any vaccine-relatedSAE‡ | 0 | 0 | 0 | 0 |
| Deaths | 2 (0.3) | 1 (0.5) | 1 (0.4) | 0 |
Pre-defined risk factors include chronic liver, lung, and heart disease, diabetes mellitus, tobacco use, and alcohol consumption. The risk factor of alcohol consumption is defined as an AUDIT-C score ≥5. Reported AEs include non-serious AEs at Days 1–14 post-vaccination and SAEs at Day 1–Month 6.
AE: adverse event; AUDIT-C: Alcohol Use Disorders Identification Test – Consumption; PCV13: 13-valent pneumococcal conjugate vaccine; SAE: serious adverse event; V114: 15-valent pneumococcal conjugate vaccine.
†All injection-site AEs were considered related to the vaccine by the investigator.
‡Determined by the investigator to be related to the vaccine.