Immunogenicity and reactogenicity of the human rotavirus vaccine, RIX4414 oral suspension, when co-administered with routine childhood vaccines in Chinese infants

Figures & data

Figure 1. Study profile for immunogenicity cohorts.

Table 1. Demographic characteristics (ATP immunogenicity cohort).

		RIX4414 group (N = 391)	Placebo group (N = 393)	Seperate cohort (N = 511)	Co-administration cohort (N = 275)
Mean age (in weeks) ± SD	RIX4414/placebo dose 1	10.0 (2.5)	10.1 (2.4)	10.1 (2.9)	10.0 (1.3)
	RIX4414/placebo dose 2	14.5 (2.6)	14.5 (2.5)	14.6 (3.0)	14.5 (1.3)
	OPV dose 1	—	—	—	10.0 (1.3)
	OPV dose 2/ DTPa dose 1	—	—	—	14.5 (1.3)
	OPV dose 3/ DTPa dose 2	—	—	—	19.0 (1.4)
	DTPa dose 3	—	—	—	23.5 (1.6)
Gender (n [%])	Female	196 (50.1)	198 (50.4)	253 (49.5)	138 (50.2)
	Male	195 (49.9)	195 (49.6)	258 (50.5)	137 (49.8)

seperate cohort: received DTPa/OPV vaccines and RIX4414/placebo at separate times.

co-adminstration cohort: received DTPa/OPV vaccines concomitantly with RIX4414/placebo.

N: number of infants included in each group.

n (%): number (percentage) of infants in each category.

DTPa: Diphtheria-tetanus-acellular pertussis.

OPV: Oral polio vaccine.

Figure 2. Anti-RV IgA seroconversion (one month post-dose-2)/seropositivity rates (at one year of age) and GMCs in seropositive subjects (separate and co-administration cohort [vaccine group]) (ATP- cohort): (a) Seroconversion / Seropositivity rates; (b) GMCs.

Table 2. Immune responses toward co-administered vaccines one month after the third vaccine dose (co-administration cohort).

		Seroprotection/ Seropositivity			Geometric mean concentration
Antibody	Group	N	n	% (95% CI)	value (95% CI)
Anti-Diphtheria ≥ 0.1 IU/ml	RIX4414	133	133	100 (97.3; 100)	0.4 (0.3; 0.4)
	Placebo	139	139	100 (97.4; 100)	0.3 (0.3; 0.4)
Anti-Tetanus ≥ 0.1 IU/ml	RIX4414	133	133	100 (97.3; 100)	1.3 (1.3; 1.3)
	Placebo	139	139	100 (97.4; 100)	1.3 (1.2; 1.5)
Anti-PT ≥ 5 EU/ml	RIX4414	133	133	100 (97.3; 100)	88.9 (84.9; 93.2)
	Placebo	139	139	100 (97.4; 100)	90.5 (86.4; 94.8)
Anti-FHA ≥ 5 EU/ml	RIX4414	133	133	100 (97.3; 100)	59.5 (55.8; 63.5)
	Placebo	139	139	100 (97.4; 100)	65.8 (61.3; 70.5)
Anti-PRN ≥ 5 EU/ml	RIX4414	133	133	100 (97.3; 100)	41.9 (37.6; 46.5)
	Placebo	139	139	100 (97.4; 100)	50.8 (44.3; 58.1)
Anti-Polio 1 ≥ 8 ED50	RIX4414	136	136	100 (97.3; 100)	2101.1 (1734.8; 2544.8)
	Placebo	139	139	100 (97.4; 100)	2259.4 (1844.4; 2767.9)
Anti-Polio 2 ≥ 8 ED50	RIX4414	136	136	100 (97.3; 100)	402.5 (334.8; 483.9)
	Placebo	139	139	100 (97.4; 100)	425.1 (371.0; 487.1)
Anti-Polio 3 ≥ 8 ED50	RIX4414	136	135	99.3 (96.0; 100)	426.6 (342.7; 531.0)
	Placebo	139	138	99.3 (96.1; 100)	360.3 (303.0; 428.3)

N: total number of infants in each group; n (%): number (percentage) of infants seroprotected/seropositive;

n': geometric mean concentration (U/ml) for all infants; 95% CI: 95% confidence interval.

PT: pertussis toxoid; FHA: filamentous haemagglutinin; PRN: pertactin.

IU: International units; EU: ELISA units; ED₅₀: Estimated dose 50%.

Table 3. Solicited symptoms (any symptom and general symptoms).

		Total vaccinated cohort Excluding co-administration cohort		Co-administration cohort
		RIX4414 (N=1513)	Placebo (N=1514)	RIX4414 (N=153)	Placebo (N=153)
		% (95% CI)	% (95% CI)	% (95% CI)	% (95% CI)
Any symptom		44.2 (41.7; 46.8)	47.3 (44.8; 49.8)	57.5 (49.3; 65.5)	52.9 (44.7; 61.1)
Grade 3		11.2 (9.7; 12.9)	10.1 (8.6; 11.7)	5.2 (2.3; 10.0)	4.6 (1.9; 9.2)
Causally related to vaccination		15.8 (14.0; 17.7)	14.7 (12.9; 16.5)	3.9 (1.5; 8.3)	2.6 (0.7; 6.6)
General symptoms
Cough/runny nose	All	20.7 (18.7; 22.8)	24.2 (22.0; 26.4)	—	—
	Grade 3	1.3 (0.8; 2.0)	0.5 (0.2; 1.0)	—	—
Diarrhea	All	8.4 (7.0; 9.9)	8.1 (6.8; 9.6)	—	—
	Grade 3	3.6 (2.8; 4.7)	4.0 (3.0; 5.1)	—	—
Irritability/Fussiness	All	27.4 (25.2; 29.8)	29.6 (27.3; 32.0)	36.6 (29.0; 44.8)	34.0 (26.5; 42.1)
	Grade 3	2.8 (2.1; 3.8)	2.6 (1.8; 3.5)	3.3 (1.1; 7.5)	2.6 (0.7; 6.6)
Loss of appetite	All	16.7 (14.9; 18.7)	16.5 (14.7; 18.5)	28.1 (21.1; 35.9)	20.9 (14.8; 28.2)
	Grade 3	0.2 (0.0; 0.6)	0.5 (0.2; 1.0)	0.7 (0.0; 3.6)	1.3 (0.2; 4.6)
Fever	All	5.5 (4.4; 6.8)	6.9 (5.6; 8.3)	3.9 (1.5; 8.3)	4.6 (1.9; 9.2)
	Grade 3	0.1 (0.0; 0.4)	0.1 (0.0; 0.5)	0.0 (0.0; 2.4)	0.7 (0.0; 3.6)
Vomiting	All	14.1 (12.4; 15.9)	15.3 (13.5; 17.2)	—	—
	Grade 3	5.3 (4.2; 6.5)	5.0 (3.9; 6.2)	—	—
Drowsiness	All	—	—	28.8 (21.7; 36.6)	24.8 (18.2; 32.5)
	Grade 3	—	—	2.0 (0.4; 5.6)	0.7 (0.0; 3.6)
Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain)	All	—	—	28.1 (21.1; 35.9)	24.8 (18.2; 32.5)
	Grade 3	—	—	1.3 (0.2; 4.6)	1.3 (0.2; 4.6)

N: total number of infants in each group; %: percentage of infants seroprotected/seropositive.

95% CI: 95% confidence interval.

Figure 3. Time points of vaccine administration and blood sampling.