Table 3.

Adverse events up to 28 days after vaccination and serious adverse events throughout follow-up

		Fractional dose group (n=126)	Standard dose group (n=124)
Overall
At least one adverse event		49 (39%)	61 (49%)
Vaccine-related adverse events		18 (14%)	33 (27%)
Severity
	Mild	48 (38%)	59 (48%)
	Moderate	1 (<1%)	2 (2%)
	Severe	0	0
	Life threatening	0	0
Serious adverse events		2 (2%)	5 (4%)
By MedDRA system organ classes and preferred terms
General disorders and administration site conditions		0	2 (2%)
	Death	0	1 (<1%)
	Sudden death, cause unknows	0	1 (<1%)
Infections and infestations		1 (<1%)	0 (0%)
	Burn infection	1 (<1%)	0 (0%)
Injury, poisoning, and procedural complaints		1 (<1%)	2 (2%)
	Subdural haematoma	0	1 (<1%)
	Tibia fracture	0	1 (<1%)
	Trauma	1 (<1%)	0
Renal and urinary disorders		0 (0%)	1 (<1%)
	Acute kidney injury secondary to tenofovir nephropathy	0 (0%)	1 (<1%)

Data are n (%).