Table 4.

Percentage of Safety Substudy Participants Reporting Solicited Adverse Events by Time Period During Days 5–28 by Vaccination Status (Vaccinated n = 204; Unvaccinated n = 230)^a

Solicited Adverse Event	Days 5–7	Days 8–14	Days 15–21	Days 22–28	Total Days 5–28b,c
Joint Paind
Vaccinated—N (%)	8 (4.0)	15 (7.4)	17 (8.5)	13 (6.5)	34 (16.7)
Unvaccinated—N (%)	4 (1.7)	2 (0.9)	3 (1.4)	2 (0.9)	11 (4.8)
P valuee	.177	<.001	<.001	.002	<.001
Joint Swelling
Vaccinated—N (%)	1 (0.5)	1 (0.5)	1 (0.5)	0	3 (1.5)
Unvaccinated—N (%)	1 (0.4)	0	0	0	1 (0.4)
P value	.996	.361	.361	-	.303
Rash
Vaccinated—N (%)	2 (1.0)	10 (5.0)	7 (3.5)	8 (4.0)	16 (7.8)
Unvaccinated—N (%)	0 (0)	1 (0.4)	2 (0.9)	2 (0.9)	4 (1.7)
P value	.144	.003	.066	.038	.003
Skin Vesicles
Vaccinated—N (%)	3 (1.5)	4 (2.0)	3 (1.5)	1 (0.5)	5 (2.5)
Unvaccinated—N (%)	0	0	1 (0.5)	2 (0.9)	2 (0.9)
P value	.068	.035	.305	.720	.228
Oral Ulcers
Vaccinated—N (%)	1 (0.5)	4 (2.0)	1 (0.5)	1 (0.5)	5 (2.5)
Unvaccinated—N (%)	0	0	1 (0.5)	1 (0.5)	2 (0.9)
P value	.360	.035	.998	.998	.228

^aExcludes 2 of the 436 substudy participants who did not have follow-up on or after day 5; for each time period, N varied from 199 to 204 for vaccinated participants and 221 to 230 for unvaccinated participants.

^bThe total may be greater than the sum of the time periods if a participant had the symptom during >1 time period.

^cThe mean proportion of days with active symptoms among vaccinated versus unvaccinated participants reporting the symptom during days 5–28 was 2.9% versus 0.3% (P < .001) for joint pain, 0.1% versus 0.0% for joint swelling (P = .260), 2.6% versus 0.4% (P = .002) for rash, 1.0% versus 0.1% (P = .189) for skin vesicles, and 0.3% versus 0.0% (P = .189) for oral ulcers.

^dOne vaccinated participant reported severe joint pain on days 21–23. This participant also reported an SAE of malaria and AE of vaginal discharge during this time period.

^e P value for difference in proportion of vaccinated and unvaccinated participants by Barnard’s exact unconditional test.