Safety & Tolerability Data in Children

Summary of Solicited Events in Children1

	Placebo Studies		Active-controlled Study
Event	2 Years to 6 Years of Age*		2 Years to 5 Years of Age†‡
	FluMist (n=876-1,764) %	Placebo (n=424-1,036) %	FluMist (n=2,170) %	Flu shot (n=2,165) %
Runny nose/nasal congestion	58	50	51	42
Decreased appetite	21	17	13	12
Irritability	21	19	12	11
Decreases activity (lethargy)	14	11	7	6
Sore throat	11	9	5	6
Headache	9	7	3	3
Muscle aches	6	3	2	2
Chills	4	3	2	2
Fever
100°-101°F Oral	9	6	6	4
101°-102°F Oral	4	3	4	3

• * Solicited events occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo observed within 10 days after dose 1 for vaccine and placebo recipients.
• † A randomized, double-blind, double-dummy comparison of FluMist intranasal mist and TIV intramuscular injection that included children 24 months to 59 months of age in the 2004-2005 influenza season (N=4,335).
• ‡ Solicited events observed within 10 days after dose 1 in children 24 months to 59 months of age.

Additional adverse reactions observed in the above trials that occurred in at least 1% of FluMist recipients, and at a higher rate compared to placebo, were abdominal pain, otitis media, diarrhea and sneezing.

In a trial of children 9 years to 17 years of age, and in a trial comparing the refrigerated and frozen formulation in children and adults 5 years to 49 years of age, solicited events and other adverse reactions were generally consistent with observations from previous trials.

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