Table 3.

Adverse events during the MenACWY-TT booster phase (total booster-vaccinated cohort).

Type of event, n (%)	MenACWY-TT (toddlers) n = 67	MenC-CRM n = 16	MenACWY-TT (children) n = 77	MenACWY-PS n = 21
All AEs	16 (23.9)	5 (31.3)	27 (35.1)	11 (52.4)
AEs reported in ≥5% of subjects in any group
Pyrexia	2 (3.0)	2 (12.5)	1 (1.3)	0
Upper respiratory tract infection	1 (1.5)	1 (6.3)	7 (9.1)	2 (9.5)
Headache	4 (6.0)	1 (6.3)	3 (3.9)	0
Injection site pruritus	1 (1.5)	1 (6.3)	1 (1.3)	0
Nasopharyngitis	0	1 (6.3)	1 (1.3)	1 (4.8)
Respiratory tract infection	0	1 (6.3)	0	1 (4.8)
Fatigue	0	1 (6.3)	0	0
Foot fracture	0	1 (6.3)	0	0
Relateda AEs	3 (4.5)	1 (6.3)	12 (15.6)	1 (4.8)
Lymph node pain	0	0	1 (1.3)	0
Axillary pain	1 (1.5)	0	0	1 (4.8)
Injection site bruising	2 (3.0)	0	0	0
Injection site hypoesthesia	0	0	1 (1.3)	0
Injection site pruritus	1 (1.5)	1 (6.3)	1 (1.3)	0
Muscle tightness	0	0	1 (1.3)	0
Musculoskeletal pain	0	0	1 (1.3)	0
Hypoesthesia	0	0	1 (1.3)	0
Insomnia	0	0	1 (1.3)	0
Cough	0	0	1 (1.3)	0
Oropharyngeal pain	0	0	1 (1.3)	0
All SAEs	0	0	1 (1.3)	0
Abdominal pain	0	0	1 (1.3)	0
Relateda SAEs	0	0	0	0
Fatal SAEs	0	0	0	0
All severe AEs	5 (7.5)	1 (6.3)	2 (2.6)	2 (9.5)
Relateda severe AEs	0	0	0	0

AE = adverse event; n (%) = number (percentage) of subjects reporting the event at least once; SAE = serious adverse event.

^aRelationship to MenACWY-TT as assessed by the investigator.

The classification of AEs is based on the Medical Dictionary for Regulatory Activities Version 21.0.