Immunogenicity and safety of a new hexavalent rotavirus vaccine in Chinese infants: A randomized, double-blind, placebo-controlled phase 2 clinical trial

Figures & data

Figure 1. Trial profile.

Table 1. Summary of demographic characteristics.

	High-dose vaccine group(N = 160)	Low-dose vaccine group（N = 160）	Placebo group（N = 160）	P
Sex, n (%)				.28
Men	79 (49.38)	74 (46.25)	88 (55.00)
Women	81(50.64)	86 (53.75)	72 (45.00)
Age, weeks				.74
Mean (SD)	8.57 (1.72)	8.69(1.95)	8.73 (2.00)
Race, n (%)				*1.00
Han	160 (100.00)	160 (100.00)	159 (99.38)
Other	0 (0.00)	0 (0.00)	1 (0.63)
Length, cm				.98
Mean (SD)	58.69 (2.531)	58.64 (2.38)	58.69 (2.44)
Weight, kg				.23
Mean (SD)	5.76 (0.79)	5.62 (0.75)	5.74 (0.84)

N: total number of vaccinations; Data are mean (SD) or n (%); *Fisher’s exact test.

Figure 2. Seroconversion rates of serum 28d after last vaccination in vaccine and placebo groups.

Table 2. Summary of IgA response to serotypes G1, G2, G3, G4, G8, and G9 in the per-protocol immunogenicity population.

Serotype	Parameter	High-dose vaccine group (n = 134)		Low-dose vaccine group(n = 134)		Placebo group (n = 127)		P
		GMC	95%CI	GMC	95%CI	GMC	95%CI
G1	Baseline	11.64	10.65–12.73	10.98	10.27–11.74	12.44	11.11–13.94	.16
	PD3	84.46	65.89–108.26	78.16	60.85–100.41	12.35	10.91–13.97	< .0001
G2	Baseline	11.45	10.56–12.40	11.02	10.28–11.82	11.61	10.54–12.78	.66
	PD3	81.47	63.19–105.04	79.81	62.10–102.55	12.28	10.84–13.91	< .0001
G3	Baseline	11.48	10.55–12.49	11.12	10.36–11.94	12.66	11.28–14.20	.12
	PD3	79.47	61.98–101.88	76.97	60.10–98.56	12.33	10.88–13.99	< .0001
G4	Baseline	11.74	10.67–12.92	11.52	10.63–12.47	13.12	11.51–14.96	.17
	PD3	79.25	61.97–101.35	78.40	61.31–100.25	12.71	11.17–14.46	< .0001
G8	Baseline	11.22	10.44–12.06	10.74	10.13–11.39	11.96	10.79–13.26	.17
	PD3	80.76	62.95–103.59	79.26	61.83–101.60	12.32	10.90–13.94	< .0001
G9	Baseline	11.6	10.57–12.73	11.27	10.45–12.17	13.07	11.54–14.80	.09
	PD3	84.17	65.83–107.60	81.88	63.70–105.24	12.53	11.05–14.22	< .0001

GMC: geometric mean concentrations; PD3: post-dose 3; n: in the per-protocol population for immunogenic evaluation on day 28 after the third dose; P: ANOVA.

Table 3. Summary of adverse events (AEs).

	High-dose vaccine group (N = 160)		Low-dose vaccine group（N = 160）		Placebo group （N = 160）		P
	n	%	n	%	n	%
All AE	134	83.75	137	85.63	128	80.00	.41
With vaccination-related AE	115	71.88	106	66.25	105	65.63	.43
Without vaccination-related AE	85	53.13	91	56.88	92	57.50	.72
Discontinued due to an AE	10	6.25	4	2.50	6	3.75
With serious AE	2	1.25	5	3.13	2	1.25	.52
Solicited AEs	114	71.25	106	66.25	104	65.00	.45
Unsolicited Aes	86	53.75	91	56.88	92	57.50	.78

N: total number of vaccinations; n: the total number of participants who had adverse reactions; %: n/N; P: Fisher’s exact test.

Table 4. Summary of solicited adverse events (AEs).

	High-dose vaccine group			Low-dose vaccine group			Placebo group			P
	N	n	%	N	n	%	N	n	%
Fever
Post1 Dose	160	69	43.13	160	58	36.25	160	54	33.75	.20
Post2 Dose	147	46	31.29	155	44	28.39	150	37	24.67	.44
Post3 Dose	145	25	17.24	155	31	20.00	149	33	22.15	.58
Post any Dose	160	93	58.13	160	83	51.88	160	84	52.50	.47
Diarrhoea
Post1 Dose	160	21	13.13	160	22	13.75	160	19	11.88	.91
Post2 Dose	147	10	6.80	155	12	7.74	150	19	12.67	.19
Post3 Dose	145	12	8.28	155	15	9.68	149	10	6.71	.65
Post any Dose	160	37	23.13	160	41	25.63	160	40	25.00	.89
Vomiting
Post1 Dose	160	8	5.00	160	6	3.75	160	6	3.75	.88
Post2 Dose	147	2	1.36	155	3	1.94	150	2	1.33	1.00
Post3 Dose	145	1	0.69	155	2	1.29	149	3	2.01	.70
Post any Dose	160	9	5.63	160	9	5.63	160	9	5.63	1.00
Anorexia
Post1 Dose	160	7	4.38	160	2	1.25	160	3	1.88	.26
Post2 Dose	147	2	1.36	155	0	0.00	150	0	0.00	.11
Post3 Dose	145	2	1.38	155	1	0.65	149	5	3.36	.21
Post any Dose	160	9	5.63	160	3	1.88	160	7	4.38	.20
Irritability/abnormal crying
Post1 Dose	160	18	11.25	160	8	5.00	160	10	6.25	.10
Post2 Dose	147	2	1.36	155	2	1.29	150	5	3.33	.48
Post3 Dose	145	4	2.76	155	3	1.94	149	3	2.01	.85
Post any Dose	160	20	12.50	160	12	7.50	160	15	9.38	.35
Drowsiness
Post1 Dose	160	5	3.13	160	5	3.13	160	3	1.88	.83
Post2 Dose	147	0	0.00	155	3	1.94	150	1	0.67	.33
Post3 Dose	145	1	0.69	155	0	0.00	149	3	2.01	.17
Post any Dose	160	6	3.75	160	8	5.00	160	5	3.13	.77
Allergy
Post1 Dose	160	0	0.00	160	3	1.88	160	0	0.00	.11
Post2 Dose	147	0	0.00	155	1	0.65	150	0	0.00	1.00
Post any Dose	160	0	0.00	160	4	2.50	160	0	0.00	.04

N: total number of vaccinations; n: the total number of participants who had adverse reactions; %: n/N; P: Fisher’s exact test.