The safety of influenza vaccine in clinically cured leprosy patients in China

Figures & data

Figure 1. Flowchart of the safety study.

Figure 2. The proportion of participants reporting solicited injection-sites AEs.

Figure 3. The proportion of participants reporting solicited systemic AEs.

Table 1. Population Demographics.

Characteristic	Leprosy group	Control group	P value
Sex, n(%)
Male	28(75.7)	41 (42.3)	0.0005
Female	9(24.3)	56 (57.7)
Age (years), mean ± SD	70.3 ± 8.3	72.7 ± 5.1	0.9780
Age, n (%)
<65 y	13	38	0.6667
≥65 y	24	59
Race, n (%)
Han	37(100)	97(100)	—
Other	0(0)	0(0)
Any significant medical history	2(5.4)	6(6.2)	1.0000

Table 2. number of subjects experiencing adverse reactions within 28 days of vaccination.

	Leprosy group		Control group
variables	Male	Female	Male	Female	P^*
Solicited injection-sites adverse events
subtotal	0	0	5	7	—
pain	0	0	1	2
itching	0	0	4	4
erythema	0	0	1	0
swelling	0	0	0	1
induration	0	0	0	1
ecchymosis	0	0	0	0
Solicited systemic adverse events
subtotal	1	0	4	3	0.4438
fever	1	0	2	2
malaise	0	0	2	1
headache	0	0	1	1
myalgia	0	0	0	0
vomiting	0	0	0	0
diarrhea	0	0	0	0
shivering	0	0	0	0
Unsolicited adverse events
Bleeding	1	0	0	0	—-
Total	2	0	7	8	0.1522

* P value were calculated by Fisher Exact test.

Table 3. Characteristics of leprosy type and nerve function impairment.

	Any AEs (N)	Non AEs (N)	P
Leprosy type
LL+BL+BB	1	18	1.0000^#
TT+BT	1	17
EHF score
0	1	1	0.0180^*
1	0	2
2	1	32

* Cochran-Mantel-Haenszel test.

^# Fisher Exact test.

LL: Lepromatous leprosy; BL: borderline Lepromatous leprosy; BB: midborderline leprosy.

TT: Turberculoid leprosy; BT: borderline Tuberculoid leprosy.

EHF score: Eye – Hand – Foot score.

Table 4. Characteristics of the Ulcers.

	Any AEs (N)	Non AEs (N)	Total (N)
Site
Plantar	2	9	11(73.3%)
Palm	0	1	1(6.3%)
Gluteal	0	1	1(6.3%)
Ankle	0	2	2(13.3%)
Volume of ulcer (mL)
0.5∼2	2	13	15(100.0%)
2～4	0	0	0(0.0%)
>4	0	0	0(0.0%)