Table 2.

Solicited and unsolicited adverse reactions^a

Variable	Inactivated vaccine (n = 100)	Ad5-nCoV (n = 100)	p
All solicited adverse reactions within 0–14 daysb
Total	25 (25.0)	55 (55.0)	<0.001
Grade 1	22 (22.0)	32 (32.0)	0.111
Grade 2	3 (3.0)	13 (13.0)	0.009
Grade 3	0 (0.0)	10 (10.0)	0.001
Injection site adverse reactions within 0–14 days
Total	18 (18.0)	44 (44.0)	<0.001
Pain	16 (16.0)	39 (39.0)	<0.001
Induration	3 (3.0)	13 (13.0)	0.121
Redness	3 (3.0)	8 (8.0)	0.121
Swelling	3 (3.0)	11 (11.0)	0.009
Grade 3	0 (0.0)	2 (2.0)	0.497
Rash	1 (1.0)	0 (0.0)	1.000
Itch	2 (2.0)	11 (11.0)	0.010
Systemic adverse reactions within 0–14 daysc
Total	12 (12.0)	35 (35.0)	<0.001
Nausea	0 (0.0)	1 (1.0)	1.000
Fever	2 (0.0)	20 (20.0)	<0.001
Grade 3	0 (0.0)	7 (7.0)	0.014
Diarrhea	3 (3.0)	4 (4.0)	1.000
Arthralgia	0 (0.0)	12 (12.0)	<0.001
Cough	0 (0.0)	5 (5.0)	0.059
Runny nose	3 (3.0)	4 (4.0)	1.000
Sneeze	1 (1.0)	2 (2.0)	1.000
Fatigue	7 (7.0)	25 (25.0)	0.001
Grade 3	0 (0.0)	1 (1.0)	1.000
Headache	3 (3.0)	19 (19.0)	<0.001
Appetite impaired	1 (1.0)	3 (3.0)	0.621
Oropharyngeal pain	1 (1.0)	4 (4.0)	0.369
Myalgia	0 (0.0)	10 (10.0)	0.001
Unsolicited adverse events within 28 days post vaccination
Total	7 (7.0)	2 (2.0)	0.170

Data are n (%). P-values of less than 0.05 were considered statistically significant.

^aSolicited adverse reactions of maximum severity were recorded for each participant over the 14 days post-vaccination. Total refers to all participants with any grade adverse reaction or event. Adverse reactions and events were graded according to the scale issued by the China State Food and Drug Administration. Grade 3 = severe (i.e., prevented activity).

^bThere were no grade 4 solicited events reported in the trial.

^cNo events were reported for cellulitis, vomiting, or chest pain. Comparisons were analyzed by Fisher’s exact test or Chi-squared test.