FluMist

Clinical Pharmacology

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Clinical Pharmacology

FluMist

In the primary efficacy analysis, FluMist demonstrated a 44.5% (95%CI: 22.4, 60.6) reduction in influenza rate compared to active control as measured by culture-confirmed modified CDC-ILI caused by wild-type strains antigenically similar to those contained in the vaccine. See Table 3 for a description of the results by strain and antigenic similarity.

Table 3 Comparative Efficacy against Culture-Confirmed Modified CDC-ILIa Caused by Wild-Type Strains in Children < 5 Years of Age

	FluMist			Active Control^b			% Reduction in Rate forFluMist^c	95% CI
	N	# of Cases	Rate (cases/N)	N	# of Cases	Rate (cases/N)	% Reduction in Rate forFluMist^c	95% CI
Matched Strains
All strains	3916	53	1.4%	3936	93	2.4%	44.5%	22.4, 60.6
A/H1N1	3916	3	0.1%	3936	27	0.7%	89.2%	67.7, 97.4
A/H3N2	3916	0	0.0%	3936	0	0.0%	--	--
B	3916	50	1.3%	3936	67	1.7%	27.3%	-4.8, 49.9
Mismatched Strains
All strains	3916	102	2.6%	3936	245	6.2%	58.2%	47.4, 67.0
A/H1N1	3916	0	0.0%	3936	0	0.0%	--	--
A/H3N2	3916	37	0.9%	3936	178	4.5%	79.2%	70.6, 85.7
B	3916	66	1.7%	3936	71	1.8%	6.3%	-31.6, 33.3
Regardless of Match
All strains	3916	153	3.9%	3936	338	8.6%	54.9%	45.4, 62.9
A/H1N1	3916	3	0.1%	3936	27	0.7%	89.2%	67.7, 97.4
A/H3N2	3916	37	0.9%	3936	178	4.5%	79.2%	70.6, 85.7
B	3916	115	2.9%	3936	136	3.5%	16.1%	-7.7, 34.7
ATP Population. ^a Modified CDC-ILI was defined as fever (temperature ≥ 100°F oral or equivalent) plus cough, sore throat, or runny nose/nasal congestion on thesame or consecutive days. ^b Injectable influenza vaccine. ^cReduction in rate was adjusted for country, age, prior influenza vaccination status, and wheezing history status.