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Table 5 Relative risk of fever ≥38.0 °C for IIV4-I versus IIV4, within 7 days post-vaccination, in infants 6–35 months in the total vaccinated 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

Axillary temperature, °C

IIV4-I n/N; %

IIV4 n/N; %

IIV4-I/IIV4 RR (95% CI)

p-value

Dose 1

≥38.0

39/462; 8.4

42/ 470; 8.9

0.94 (0.59, 1.50)

0.8851

Dose 2

≥38.0

40/420; 9.5

40/421; 9.5

1.00 (0.63, 1.59)

1.000

Overall

≥38.0

72/462; 15.6

69/470;14.7

1.06 (0.75, 1.50)

0.7868

  1. IIV4-I quadrivalent inactivated influenza vaccine manufacturing by investigational process, IIV4 licensed quadrivalent inactivated influenza vaccine, RR relative risk, N, number of subjects with ≥1 vaccine dose and returned diary cards; n, number of subjects reporting the event