Table 3.

Unsolicited adverse events—toddler and infant cohorts

			Toddlers				Infants
			MRV-MNP and placebo-SC, n=60		MRV-SC and placebo-MNP, n=60		MRV-MNP and placebo-SC, n=60		MRV-SC and placebo-MNP, n=60
			n (%)	E	n (%)	E	n (%)	E	n (%)	E
Adverse events
Total			59 (98%)	203	56 (93%)	187	60 (100%)	347	59 (98%)	285
	Mild (grade 1)		47 (78%)	190	38 (63%)	162	39 (65%)	315	44 (73%)	267
	Moderate (grade 2)		11 (18%)	12	13 (22%)	20	21 (35%)	32	14 (23%)	17
	Severe (grade 3)		1 (2%)	1	5 (8%)	5	0	0	1 (2%)	1
Serious adverse events			1 (2%)	1	7 (12%)	8	1 (2%)	1	1 (2%)	1
Adverse events resulting in discontinuation from the study			0	0	0	0	0	0	0	0
Related adverse events
Total			35 (58%)	43	16 (27%)	16	57 (95%)	75	38 (63%)	41
	Mild (grade 1)		35 (58%)	42	16 (27%)	16	57 (95%)	75	38 (63%)	41
		MNP site discolouration	29 (48%)	29	12 (20%)	12	50 (83%)	50	32 (53%)	32
		MNP site exfoliation	5 (8%)	5	1 (2%)	1	14 (23%)	14	6 (10%)	6
		MNP site induration	3 (5%)	3	0	0	7 (12%)	7	1 (2%)	1
		Other	5 (8%)	5*	3 (5%)	3†	4 (7%)	4‡	2 (3%)	2§
	Moderate (grade 2)		1 (2%)	1¶	0	0	0	0	0	0
Related serious adverse events			0	0	0	0	0	0	0	0

Data are n (%), where n=number of participants experiencing event by maximum severity grading, unless otherwise stated. MRV=measles and rubella vaccine. MNP=microneedle patch. SC=subcutaneous. E=number of events by maximum severity grade.

^*Two MNP site papules, one MNP site pruritus, two SC injection site induration.

^†One MNP site papules, two generalised maculopapular rash.

^‡One MNP site macule, one generalised rash, one generalised papular rash; one poor infant feeding.

^§One MNP site papules, one diarrhoea.

^¶One generalised papular rash.