Table 3.

Local and systemic reactions in the 7 days after vaccination and protocol-defined wheezing illness at any time

	LAIV (n=1174)			Placebo (n=587)			Whole population (n=1761)
	Mild	Moderate	Severe	Mild	Moderate	Severe	Mild	Moderate	Severe
Local and systemic reactions
Fever (≥38°C)	17 (1·4%)	20 (1·1%)	0	8 (1·4%)	8 (1·4%)	0	25 (1·4%)	28 (1·6%)	0
Nasal congestion	1 (0·1%)	0	0	1 (0·2%)	0	0	2 (0·1%)	0	0
Runny nose	68 (5·8%)	0	0	39 (6·6%)	0	0	107 (6·1%)	0	0
Cough	72 (6·1%)	1 (0·1%)	0	43 (7·3%)	0	0	115 (6·5%)	1 (0·1%)	0
Sore throat	4 (0·3%)	0	0	2 (0·3%)	0	0	6 (0·3%)	0	0
Ear pain	2 (0·2%)	0	0	3 (0·5%)	0	0	5 (0·3%)	0	0
Headache	0	0	0	1 (0·2%)	0	0	1 (0·1%)	0	0
Vomiting	4 (0·3%)	0	0	5 (0·9%)	1 (0·2%)	0	9 (0·5%)	1 (0·1%)	0
Chills	0	0	0	0	0	0	0	0	0
Irritability or decreased activity	1 (0·1%)	0	0	0	0	0	1 (0·1%)	0	0
Muscle/joint pain	3 (0·3%)	1 (0·1%)	0	0	0	0	3 (0·2%)	1 (0·1%)	0
Tachypnoea*	77 (6·6%)	9 (0·5%)	0	53 (9·0%)	1 (0·2%)	0	130 (7·4%)	10 (0·6%)	0
Protocol-defined wheezing illness
Days 0–7	4 (0·3%)	0	0	1 (0·2%)	0	0	5 (0·3%)	0	0
Days 8–42	16 (1·4%)	0	0	9 (1·5%)	0	0	25 (1·4%)	0	0
Day 43 to 6 months	38 (3·2%)	1 (0·1%)	0	31 (5·3%)	1 (0·2%)	0	69 (3·9%)	2 (0·1%)	0
Day 0 to 6 months	53 (4·5%)	1 (0·1%)	0	37 (6·3%)	1 (0·2%)	0	90 (5·1%)	2 (0·1%)	0
Anytime†	78 (6·6%)	3 (0·3%)	0	46 (7·8%)	4 (0·7%)	0	124 (7·0%)	7 (0·4%)	0

LAIV=live attenuated influenza vaccine.

^*Mild 31–40 breaths per min, moderate 41–50 breaths per min, and severe ≥51 breaths per min.

^†Including events occurring >6 months after vaccination.