Table 3.
Local and Systemic Reactogenicity Through Day 7 by Vaccination Status: Safety Substudy
| Vaccinated (N = 205) | Unvaccinated (N = 231) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Any | Severea | Any | Severea | Any | Severea | |||||
| Adverse Event | N (%) | (95% CI) | N (%) | (95% CI) | N (%) | (95% CI) | N (%) | (95% CI) | P Valueb | |
| Systemic Adverse Events | ||||||||||
| Elevated temperaturec | 42 (20.5) | (15.2–26.7) | 4 (2.0) | (0.5–4.9) | 9 (3.9) | (1.8–7.3) | 0 | (0.0–1.6) | <.001 | .034 |
| Feverishness | 104 (50.7) | (43.7–57.8) | 0 | (0.0–1.8) | 22 (9.5) | (6.1–14.1) | 0 | (0.0–1.6) | <.001 | - |
| Fatigue | 104 (50.7) | (43.7–57.8) | 1 (0.5) | (<0.1–2.7) | 24 (10.4) | (6.8–15.1) | 0 | (0.0–1.6) | <.001 | .360 |
| Feeling unwell | 58 (28.3) | (22.2–35.0) | 0 | (0.0–1.8) | 15 (6.5) | (3.7–10.5) | 0 | (0.0–1.6) | <.001 | - |
| Muscle pain | 59 (28.8) | (22.7–35.5) | 0 | (0.0–1.8) | 8 (3.5) | (1.5–6.7) | 0 | (0.0–1.6) | <.001 | - |
| Joint pain | 65 (31.7) | (25.4–38.6) | 0 | (0.0–1.8) | 15 (6.5) | (3.7–10.5) | 0 | (0.0–1.6) | <.001 | - |
| Joint swelling | 6 (2.9) | (1.1–6.3) | 0 | (0.0–1.8) | 2 (0.9) | (0.1–3.1) | 0 | (0.0–1.6) | .116 | - |
| Chills | 37 (18.0) | (13.0–24.0) | 0 | (0.0–1.8) | 10 (4.3) | (2.1–7.8) | 0 | (0.0–1.6) | <.001 | - |
| Headache | 146 (71.2) | (64.5–77.3) | 1 (0.5) | (<0.1–2.7) | 51 (22.1) | (16.9–28.0) | 0 | (0.0–1.6) | <.001 | .360 |
| Vomiting | 1 (0.5) | (<0.1–2.7) | 0 | (0.0–1.8) | 1 (0.4) | (<0.1–2.4) | 0 | (0.0–1.6) | .996 | - |
| Nausea | 10 (4.9) | (2.4–8.8) | 0 | (0.0–1.8) | 1 (0.4) | (<0.1–2.4) | 0 | (0.0–1.6) | .003 | - |
| Diarrhea | 4 (2.0) | (0.5–4.9) | 0 | (0.0–1.8) | 2 (0.9) | (0.1–3.1) | 0 | (0.0–1.6) | .371 | - |
| Abdominal pain | 23 (11.2) | (7.2–16.4) | 1 (0.5) | (<0.1–2.7) | 4 (1.7) | (0.5–4.4) | 0 | (0.0–1.6) | <.001 | .360 |
| Rash | 13 (6.3) | (3.4–10.6) | 0 | (0.0–1.8) | 1 (0.4) | (<0.1–2.4) | 0 | (0.0–1.6) | <.001 | - |
| Oral ulcers | 3 (1.5) | (0.3–4.2) | 0 | (0.0–1.8) | 1 (0.4) | (<0.1–2.4) | 0 | (0.0–1.6) | .303 | - |
| Skin vesicles | 7 (3.4) | (1.4–6.9) | 0 | (0.0–1.8) | 0 | (0.0–1.6) | 0 | (0.0–1.6) | .005 | - |
| Any systemic adverse eventsd | 187 (91.2) | (86.5–94.7) | 5 (2.4) | (0.8–5.6) | 82 (35.5) | (29.3–42.0) | 0 | (0.0–1.6) | <.001 | .017 |
| Local Adverse Events | ||||||||||
| Pain | 166 (81.0) | (74.9–86.1) | 0 | (0.0–1.8) | N/A | N/A | N/A | N/A | N/A | N/A |
| Redness (measurement grade) | 2 (1.0) | (0.1–3.5) | 0 | (0.0–1.8) | N/A | N/A | N/A | N/A | N/A | N/A |
| Swelling (measurement grade) | 6 (2.9) | (1.1–6.3) | 0 | (0.0–1.8) | N/A | N/A | N/A | N/A | N/A | N/A |
| Any local adverse eventsd | 166 (81.0) | (74.9–86.1) | 0 | (0.0–1.8) | N/A | N/A | N/A | N/A | N/A | N/A |
| Any Adverse Eventsd | 196 (95.6) | (91.8–98.0) | 5 (2.4) | (0.8–5.6) | 82 (35.5) | (29.3–42.0) | 0 | (0.0–1.6) | <.001 | .017 |
Abbreviations: CI, confidence interval; N/A, not applicable.
aMarked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible.
b P value for difference in proportion of vaccinated and unvaccinated participants by Barnard’s exact unconditional test.
cElevated temperature defined as ≥38.0°C for any adverse event and ≥39.0°C for a severe adverse event.
dTotals reflect the number of participants with ≥1 adverse event.