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

From: 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

  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*
  1. 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.
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