Intanza^® 9 µg intradermal seasonal influenza vaccine for adults 18 to 59 years of age

Figures & data

Figure 1. The Intanza 9 μg system. (A) Features of the Intanza 9 μg system. The enlarged area shows images of the microinjection needle and a regular IM needle. (B) ID injection with the Intanza 9 μg system.

Table 1. Clinical studies in which Intanza 9 μg was evaluated in adults 18 to 59 y of age

Clinical trial registration no.	Influenza season	Phase	Number of subjects	Reference
NCT00703651	2005/06 (year 3 of 3)^a	II	828	Beran et al. 2009^55
NCT00258934	2005/06	II	978	Leroux-Roels et al. 2008^56
NCT00383539	2006/07	III	2255	Arnou et al. 2010^57

^a The final version of Intanza 9 μg was used only in the last year of this 3-y study.

Table 2. Immunogenicity of Intanza 9 μg and the IM reference vaccine (Vaxigrip) in adults 18 to 59 y of age

Study	Measure	Strain A/H1N1		Strain A/H3N2		Strain B
		ID 9 μg	IM 15 μg	ID 9 μg	IM 15 μg	ID 9 μg	IM 15 μg
NCT00703651 (Year 3)	Seroprotection (%)	90.7 [83.6;95.5]	91.3 [84.2;96.0]	100.0 [96.6;100.0]	99.0 [94.8;100.0]	83.3 [74.9;89.8]	81.4 [72.4;88.4]
	Seroconversion (%)	14.8 [8.7;22.9]	18.3 [11.4;27.1]	60.2 [50.3;69.5]	45.2 [35.4;55.3]	24.1 [16.4;33.3]	19.6 [12.4;28.6]
	GMT ratio	2.0 [1.7;2.4]	2.1 [1.7;2.5]	4.6 [3.8;5.6]	3.5 [2.8;4.4]	2.3 [1.9;2.7]	2.3 [1.9;2.8]
NCT00258934	Seroprotection (%)	92.4% [89.3;94.9]	88.8% [85.3;91.8]	99.7% [98.6;100.0]	98.7% [97.0;99.6]	90.6% [87.2;93.3]	85.5% [81.5;88.8]
	Seroconversion (%)	74.3% [69.7;78.7]	70.4% [65.6;74.9]	85.1% [81.2;88.5]	79.2% [74.8;83.1]	76.4% [71.9;80.6]	73.5% [68.8;77.8]
	GMT ratio	16.2 [13.7;19.2]	13.8 [11.6;16.4]	28.2 [23.7;33.5]	20.7 [17.5;24.4]	12.1 [10.5;13.8]	10.84 [9.56;12.29]
NCT00383539	Seroprotection (%)	87.2 [85.2;89.0]	86.2 [82.6;89.3]	93.5 [92.0;94.8]	95.4 [93.0;97.2]	72.9 [70.4;75.3]	74.8 [70.4;78.8]
	Seroconversion (%)	57.5 [54.7;60.2]	56.4 [51.6;61.1]	66.5 [63.8;69.0]	69.3 [64.7;73.6]	56.7 [54.0;59.4]	60.8 [56.0;65.4]
	GMT ratio	9.17 [8.33;10.1]	9.71 [8.19;11.5]	11.5 [10.4;12.7]	11.2 [9.58;13.1]	6.39 [5.96;6.84]	6.63 [5.90;7.46]

Values are means with 95% confidence intervals in brackets. As described in the CPMP Note for Guidance,⁵⁴ seroprotection was defined as a HI titer ≥ 40, seroconversion as a post-vaccination HI titer ≥ 40 in seronegative subjects or a ≥ 4-fold increase in HI titer, and GMT ratio as the ratio of post-vaccination HI GMT to pre-vaccination HI GMT. GMT, geometric mean titer.

Table 3. Percentage of clinical trial subjects 18 to 59 y of age with solicited reactions within 7 d of vaccination with Intanza 9 μg and the IM reference vaccine (Vaxigrip)

	NCT00703651 (Year 3)		NCT00258934 (year 1)		NCT00383539
Reaction	Intanza® 9 μg	Vaxigrip®	Intanza® 9 μg	Vaxigrip®	Intanza® 9 μg	Vaxigrip®
Solicited injection site reactions	75.8	45.5	94.3 [92.1;96.1]	49.5 [44.4;54.6]	92.2 [90.9;93.4]	66.3 [61.7;70.7]
Erythema	65.6	12.2	86.8 [83.7;89.4]	11.5 [8.5;15.1]	84.4 [82.6;86.0]	25.5 [21.5;29.8]
Swelling	NR	NR	65.2 [61.2;69.1]	8.1 [5.6;11.3]	61.9 [59.6;64.1]	20.7 [17.0;24.8]
Induration	39.7	12.0	63.5 [59.4;67.4]	12.8 [9.6;16.5]	60.8 [58.5;63.1]	26.1 [22.1;30.5]
Pain	43.1	37.1	38.1 [34.1;42.2]	38.8 [33.9;43.9]	43.1 [40.8;45.5]	48.4 [43.7;53.2]
Pruritus	28.9	7.6	36.3 [32.4;40.4]	4.4 [2.6;7.0]	44.8 [42.5;47.2]	13.1 [10.1;16.6]
Ecchymosis	3.3	3.2	3.1 [1.9;4.9]	2.6 [1.3;4.7]	10.0 [8.6;11.5]	9.9 [7.3;13.1]
Edema	35.9	8.0	NR	NR	NR	NR
Solicited systemic reactions	29.4	24.6	45.3 [41.2;49.5]	49.7 [44.6;54.9]	44.4 [42.1;46.8]	47.9 [43.1;52.6]
Fever	2.4	0.5	3.5 [2.1;5.3]	3.6 [2.0;6.0]	3.9 [3.0;4.9]	3.4 [1.9;5.5]
Asthenia	17.9	12.7	NR	NR	NR	NR
Headache	16.5	13.9	33.2 [29.4;37.2]	30.2 [25.7;35.1]	29.2 [27.1;31.3]	30.0 [25.7;34.5]
Arthralgia	6.2	2.0	NR	NR	NR	NR
Myalgia	11.2	10.0	19.7 [16.6;23.2]	29.4 [24.9;34.3]	23.5 [21.6;25.6]	29.5 [25.3;34.0]
Shivering	8.4	7.6	6.6 [4.7;8.9]	8.6 [6.0;11.9]	9.4 [8.1;10.9]	7.4 [5.2;10.3]
Increased sweating	6.7	6.1	NR	NR	NR	NR
Malaise	4.3	5.4	14.5 [11.8;17.7]	17.2 [13.5;21.3]	18.2 [16.4;20.1]	19.4 [15.8;23.4]

Values are means with 95% confidence intervals (where available) in brackets. NR, not reported.

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