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

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

	Primary vaccine group
	AS03_A-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%)	_

^†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.

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