Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged ≥18 years

Table 6 Overview of unsolicited AEs and MAEs in the total vaccinated cohort

	QIV	TIV-Vic	TIV-Yam
	N = 3036	N = 1010	N = 610
Adverse events Day 0–20, n (%)
Subjects with ≥ 1 event	379 (12.5)	138 (13.7)	92 (15.1)
Subjects with ≥ 1 Grade 3 event	39 (1.3)	7 (0.7)	2 (0.3)
Subjects with ≥ 1 event related to vaccination^†	64 (2.1)	26 (2.6)	14 (2.3)
No. of events by MedDRA preferred term	558	195	125
No. of Grade 3 events by MedDRA preferred term	52	8	2
No. of events by MedDRA preferred term related to vaccination^†	89	38	16
Medically-attended adverse events Day 0–20, n (%)
Subjects with ≥ 1 event	193 (6.4)	60 (5.9)	47 (7.7)
No. of events by MedDRA preferred term	250	75	63
Medically-attended adverse events Day 0–180, n (%)
Subjects with ≥ 1 event	688 (22.7)	216 (21.4)	NA*
No. of events by MedDRA preferred term	1151	379	NA*

AE adverse event, MAE medically-attended adverse event, QIV inactivated quadrivalent influenza vaccine, TIV-Vic inactivated trivalent influenza vaccine Victoria lineage B strain, TIV-Yam inactivated trivalent influenza vaccine Yamagata lineage B strain, MedDRA Medical Dictionary for Regulatory Activities, NA not applicable, ^†Based on investigator’s assessment of causality; *TIV-YAM group was followed up until Day 21.

ISSN: 1471-2334