An evaluation of a test-negative design for EV-71 vaccine from a randomized controlled trial

Figures & data

Table 1. Comparison of demographic characteristics between cases and controls in mITT and PPS

Modified intention-to-treat population	cases(52)	controls(7276)	P
sex(male,%)	30(57.7%)	4117(56.6%)	0.8749
age(month)	19.5 ± 8.3	18.3 ± 8.0	0.2957
height(cm)	82.8 ± 9.0	81.4 ± 8.1	0.1997
weight(kg)	12.9 ± 2.7	12.4 ± 2.2	0.2523
Per-protocol population	cases(49)	controls(7091)
sex(male,%)	29(59.2%)	400(56.4%)	0.6988
age(month)	19.8 ± 8.3	18.4 ± 8.0	0.2084
height(cm)	83.2 ± 9.0	81.4 ± 8.1	0.1203
weight(kg)	13.0 ± 2.7	12.5 ± 2.2	0.1560

Sex: percent of male, P value was examined by Chi2 Test; Age: mean±SD, P value was examined by Anova; Height: mean±SD, P value was examined by Anova; Weight: mean±SD, P value was examined by Anova; Cases were detected EV71 positive while controls were detected EV71 negative.

Table 2. VE-TND and VE-RCT results

Modified intention-to-treat population	Case^#	Controls^#	VE-TND%(95%CI)	VE-RCT%(95%CI)
EV71-associated disease	8/44	3628/3645	81.7(61.1,91.4)	81.9(61.5,91.5)
EV71-associated HFMD	3/33	720/697	91.2(71.2,97.3)	90.9(70.4,97.2)
EV71-associated other cases	5/11	2908/2948	53.9(−32.9,84.0)	54.6(–30.6,84.2)
Per-protocol population
EV71-associated disease	8/41	3522/3566	80.2(57.8,90.8)	80.4(58.2,90.8)
EV71-associated HFMD	3/30	705/686	90.3(68.0,97.0)	90.0(67.1,96.9)
EV71-associated other cases	5/11	2817/2880	53.5(−33.9,83.9)	54.3(–31.4,84.1)

#:Vaccination/Placebo; Data about VE-RCT was from the original phase 3 trial. VE-TND was calculated by Logistic regression. Cases were detected EV71 positive while controls were detected EV71 negative.

Figure 1. VE-TND and VE-RCT and 95% confidence intervals in mITT

Figure 2. VE-TND and VE-RCT and 95% confidence intervals in PPS

Figure 3. Suspected EV71 infected cases epidemic curves in mITT and PPS