Table 2.

Solicited safety events from days 0 to 13—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
Acute allergic reaction				0	0	0	0
Local solicited adverse events
	MNP application site
		Any local solicited event*
			Total	50 (83%)	18 (30%)	46 (77%)	18 (30%)
			Mild (grade 1)	50 (83%)	18 (30%)	46 (77%)	18 (30%)
		Tenderness
			Total	1 (2%)	1 (2%)	0	0
			Mild (grade 1)	1 (2%)	1 (2%)	0	0
		Erythema
			Total	10 (17%)	9 (15%)	18 (30%)	14 (23%)
			Mild (grade 1)	10 (17%)	9 (15%)	18 (30%)	14 (23%)
		Induration
			Total	46 (77%)	9 (15%)	39 (65%)	6 (10%)
			Mild (grade 1)	46 (77%)	9 (15%)	39 (65%)	6 (10%)
SC injection site
	Any local solicited event*
		Any reaction		8 (13%)	5 (8%)	2 (3%)	4 (7%)
			Mild (grade 1)	6 (10%)	5 (8%)	2 (3%)	4 (7%)
			Moderate (grade 2)	2 (3%)	0	0	0
Systemic solicited adverse events
	Fever
		Total		5 (8%)	11 (18%)	8 (13%)	4 (7%)
			Mild (grade 1)	1 (2%)	9 (15%)	5 (8%)	4 (7%)
			Moderate (grade 2)	4 (7%)	1 (2%)	3 (5%)	0
			Severe (grade 3)	0	1 (2%)	0	0
	Any systemic solicited event†
		Total		27 (45%)	30 (50%)	31 (52%)	24 (40%)
			Mild (grade 1)	24 (40%)	23 (38%)	28 (47%)	23 (38%)
			Moderate (grade 2)	3 (5%)	7 (12%)	3 (5%)	1 (2%)

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

^*Tenderness, erythema, and induration.

^†Vomiting, diarrhoea, irritability, drowsiness, reduced feeding, and rash.