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Table 5 Summary of 30-day post-vaccination safety in the total vaccinated cohort

From: Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults

  Primary vaccine group
AS03A-H5N1 Non-adjuvanted-H5N1
Month 6 booster N = 265 N = 236
No. subjects with ≥1 unsolicited symptom 65 (24.5%) 54 (22.9%)
No. of events by MedDRA preferred term 88 78
No. of Grade 3 events by MedDRA preferred term 6 6
No. of events by MedDRA preferred term related to vaccination 26 18
Month 12 booster N = 188 _
No. subjects with ≥1 unsolicited symptom 44 (23.4%) _
No. of events by MedDRA preferred term 67 _
No. of Grade 3 events by MedDRA preferred term 8 _
No. of events by MedDRA preferred term related to vaccination 25 _
Month 36 booster N = 390 _
No. subjects with ≥1 unsolicited symptom 85 (21.8%)
No. subjects with Grade 3 unsolicited symptom 9 (2.3%) _
No. subjects with unsolicited symptom related to vaccination 34 (8.7%) _
  1. Based on investigators’ assessment of causality; Symptoms reported by participant after a given dose with the same preferred term were counted once; N, number of subjects in group; Subjects in the AS03-H5N1 primary vaccine group received one booster dose at allocated time-point, and subjects in the non-adjuvanted H5N1 primary group received two doses of booster vaccine at Month 6; primary vaccine strain, H5N1/A/Vietnam/1194/2004; booster strain H5N1/A/Indonesia/5/2005.