Reactogenicity and safety of AS03B-adjuvanted H5N1 influenza vaccine in children: an open-label, one-way, crossover trial

Figures & Tables

AE type	TVC (N = 155)

	n	% (95% CI)
Days 0–42
≥1 AE(s)	41	26.5 (19.7, 34.1)
≥1 Grade 3 AE(s)	3	1.9 (0.4, 5.6)
≥1 AE(s) causally related to vaccination Causal relationship with vaccination based on the medical assessment by the investigator	3	1.9 (0.4, 5.6)
Days 0–385
≥1 MAE(s)	36	23.2 (16.8, 30.7)
≥1 SAE(s)	2	1.3 (0.2, 4.6)
≥1 pIMD	0	–

Solicited symptom				TVC Includes all children who received at least one dose of vaccine for whom diary cards of solicited events were available (N = 154)
		All events				Grade 3

	n			% (95% CI)	n			% (95% CI)

Injection site
Pain	111			72.1 (64.3, 79.0)	8			5.2 (2.3, 10.0)
Redness	6			3.9 (1.4, 8.3)	0			0.0 (0.0, 2.4)
Swelling	5			3.2 (1.1, 7.4)	0			0.0 (0.0, 2.4)

		<6 years (n = 79)				6–<18 years (n = 75)

	All events		Grade 3		All events		Grade 3

	n	% (95% CI)	n	% (95% CI)	n	% (95% CI)	n	% (95% CI)

General
Drowsiness	23	29.1 (19.4, 40.4)	1	1.3 (0.0, 6.9)	–		–
Irritability/fussiness	28	35.4 (25.0, 47.0)	1	1.3 (0.0, 6.9)	–		–
Loss of appetite	18	22.8 (14.1, 33.6)	0	0.0 (0.0, 4.6)	–		–
Increased temperature	4	5.1 (1.4, 12.5)	2	2.5 (0.3, 8.8) ≥39°C	1	1.3 (0.0, 7.2)	0	0.0 (0.0, 4.8) ≥39°C
Fatigue	–		–		18	24.0 (14.9, 35.3)	1	1.3 (0.0, 7.2)
Gastrointestinal disorder	–		–		7	9.3 (3.8, 18.3)	0	0.0 (0.0, 4.8)
Headache	–		–		24	32.0 (21.7, 43.8)	1	1.3 (0.0, 7.2)
Increased sweating	–		–		5	6.7 (2.2, 14.9)	0	0.0 (0.0, 4.8)
Joint pain	–		–		14	18.7 (10.6, 29.3)	0	0.0 (0.0, 4.8)
Muscle aches	–		–		34	45.3 (33.8, 57.3)	0	0.0 (0.0, 4.8)
Shivering (chills)	–		–		7	9.3 (3.8, 18.3)	2	2.7 (0.3, 9.3)