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Table 2 Immunogenic non-inferiority 28 days after last vaccination for IIV4 versus IIV4-I in children and infants in the per-protocol immunogenicity cohort

From: Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults

 

IIV4-I

IIV4

IIV4/IIV4-I

Adjusted GMT

Adjusted GMT

Adjusted GMT ratio (95% CI)

Infants, 6–35 months

N = 431

N = 423a

 

 A/H1N1

98.0

105.3

1.07 (0.90, 1.28)

 A/H3N2

47.7

56.3

1.18 (1.00, 1.39)

 B/Yamagata

99.2

106.4

1.07 (0.91, 1.27)

 B/Victoria

32.2

37.7

1.17 (0.99, 1.38)

Children, 3–17 years

N = 403

N = 402

 

 A/H1N1

707.3

684.9

0.97 (0.85, 1.11)

 A/H3N2

160.6

168.8

1.05 (0.94, 1.18)

 B/Yamagata

496.0

509.4

1.03 (0.91, 1.16)

 B/Victoria

240.8

250.4

1.04 (0.90, 1.21)

  1. IIV4-I quadrivalent inactivated influenza vaccine manufacturing by investigational process, IIV4 licensed quadrivalent inactivated influenza vaccine, GMT geometric mean titer adjusted for age and pre-vaccination titers, CI confidence interval
  2. aA/H1N1, N = 424; N, number of subjects in the per-protocol cohort with both pre-and post-vaccination results available
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BMC Infectious Diseases

ISSN: 1471-2334

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