Table 1.
Baseline characteristics and solicited adverse events after each vaccine dose.
| Baseline Characteristics | Dose 1 (n = 177) |
Dose 2 (n = 171) |
p-Value |
|---|---|---|---|
| Age, mean ± SD (range) | 25.4 ± 3.83 (20–55) | 25.4 ± 3.88 (20–55) | |
| 20–29 years | 171 | 165 | |
| 30–39 years | 4 | 4 | |
| 40–49 years | 1 | 1 | |
| 50–54 years | 1 | 1 | |
| Male, number (%) | 53 (29.9%) | 53 (31.0%) | |
| BMI, mean ± SD | 21.50 ± 2.87 | 21.58 ± 2.88 | |
| AE experienced after each dose | |||
| Any AE, number (%) | 176 (99.4%) | 168 (98.2%) | 0.625 |
| Any systemic AE, number (%) | 155 (87.6%) | 163 (95.3%) | 0.007 |
| fever | 38 (21.5%) | 125 (73.1%) | <0.001 |
| chills | 37 (20.9%) | 121 (70.8%) | <0.001 |
| headache | 56 (31.6%) | 120 (70.2%) | <0.001 |
| muscle pain | 130 (73.4%) | 141 (82.5%) | 0.038 |
| fatigue | 104 (58.8%) | 134 (78.4%) | <0.001 |
| joint pain | 17 (9.6%) | 45 (26.3%) | <0.001 |
| vomiting | 3 (1.7%) | 16 (9.4%) | 0.002 |
| rash | 13 (7.3%) | 11 (6.4%) | 0.815 |
| dyspnea | 5 (2.8%) | 6 (3.5%) | 1.000 |
| flushing/lip swelling | 5 (2.8%) | 1 (0.6%) | 0.219 |
| facial palsy | 5 (2.8%) | 1 (0.6%) | 0.219 |
| paresthesia | 15 (8.5%) | 8 (4.7%) | 0.189 |
| Any local AE, number (%) | 174 (98.3%) | 164 (95.9%) | 0.289 |
| injection site pain | 170 (96.0%) | 161 (94.2%) | 0.549 |
| injection site redness/swelling | 27 (15.3%) | 38 (22.2%) | 0.080 |
| limited motion | 158 (89.3%) | 152 (88.9%) | 1.000 |
| Severity of AE, mean ± SD a | |||
| maximum severity | 1.94 ± 0.75 | 2.29 ± 0.76 | <0.001 |
| highest grade of systemic AE | 1.25 ± 0.77 | 1.98 ± 0.88 | <0.001 |
| highest grade of local AE | 1.86 ± 0.74 | 1.87 ± 0.79 | 0.770 |
| systemic SUM | 2.99 ± 2.95 | 6.71 ± 4.06 | <0.001 |
| systemic SoM | 4.71 ± 5.31 | 10.55 ± 8.00 | <0.001 |
| localized SUM | 3.28 ± 1.53 | 3.40 ± 1.69 | 0.295 |
| localized SoM | 4.51 ± 2.34 | 4.74 ± 2.62 | 0.214 |
| Antipyretic use, number (%) | 107 (60.5%) | 155 (90.6%) | <0.001 |
a Severity was calculated by considering only some AEs (local AEs including pain, redness/swelling, motion limitation, and systemic AEs including fever, chills, headache, muscle pain, fatigue, joint pain, and vomiting). AE, adverse event; SUM, sum of each symptoms’ severity score; SoM, sum of multiplying each symptom severity by duration (days).