Information for Healthcare Professionals

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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