Table 3.

Number and percentage of subjects reporting solicited general AEs during the 21-day follow-up period post-vaccination (total vaccinated cohort)

	Type	F17 (N = 40)			F19 (N = 39)			Placebo (N = 40)
		n	%	95% CI	n	%	95% CI	n	%	95% CI
Fatigue	All	29	72.5	56.1–85.4	17	43.6	27.8–60.4	17	42.5	27.0–59.1
Fatigue	Grade 3	1	2.5	0.1–13.2	NR			NR
Fever	All	18	45.0	29.3–61.5	15	38.5	23.4–55.4	13	32.5	18.6–49.1
Fever	Grade 3	1	2.5	0.1–13.2	NR			1	2.5	0.1–13.2
Headache	All	28	70.0	53.5–83.4	10	25.6	13.0–42.1	17	42.5	27.0–59.1
Headache	Grade 3	1	2.5	0.1–13.2	NR			NR
Muscle aches	All	19	47.5	31.5–63.9	9	23.1	11.1–39.3	10	25.0	12.7–41.2
Nausea	All	7	17.5	7.3–32.8	2	5.1	0.6–17.3	4	10.0	2.8–23.7
Nausea	Grade 3	1	2.5	0.1–13.2	NR			NR
Pain behind eyes	All	16	40.0	24.9–56.7	7	17.9	7.5–33.5	9	22.5	10.8–38.5
Abdominal pain	All	4	10.0	2.8–23.7	3	7.7	1.6–20.9	4	10.0	2.8–23.7
Arthralgia	All	6	15.0	5.7–29.8	3	7.7	1.6–20.9	1	2.5	0.1–13.2
Photophobia	All	4	10.0	2.8–23.7	1	2.6	0.1–13.5	3	7.5	1.6–20.4
Pruritus	All	9	22.5	10.8–38.5	7	17.9	7.5–33.5	7	17.5	7.3–32.8
Pruritus	Grade 3	1	2.5	0.1–13.2	NR			NR
Rash	All	9	22.5	10.8–38.5	3	7.7	1.6–20.9	4	10.0	2.8–23.7
Rash	Grade 3	2	5.0	0.6–16.9	NR			NR
Vomiting	All	1	2.5	0.1–13.2	1	2.6	0.1–13.5	1	2.5	0.1–13.2

No grade 3 symptoms were reported for abdominal pain, arthralgia, muscle aches, pain behind eyes, photophobia, and vomiting. All = includes all grades (1–3) reported after both doses; fever = oral temperature ≥ 37.5°C; grade 3 fever = oral temperature > 39.0°C; N = number of subjects with at least one documented dose; n/% = number/percentage of subjects reporting the symptom at least one time; NR = none reported; Gr 3 = grade 3; 95% CI = exact 95% confidence interval.