Table 3.

Number of women and infants reporting unsolicited adverse events and serious adverse events

	HIV-infected, low CD4 cell count (90 women and 91 infants)	HIV-infected, high CD4 cell count (89 women and 88 infants)	HIV-uninfected (90 women and 87 infants)
Women
Any adverse event	67 (74%)	68 (76%)	70 (78%)
Adverse event possibly related to vaccine	6 (7%)	12 (13%)	21 (23%)
Serious adverse event*	25 (28%)	28 (31%)	29 (32%)
Adverse event leading to participant withdrawing from the trial	0	1 (1%)	0
Medically attended adverse event	42 (47%)	44 (49%)	49 (54%)
Death†	0	1 (1%)	0
Infants
Any adverse event	37 (41%)	43 (49%)	37 (43%)
Adverse event possibly related to vaccine	0	2 (2%)	1 (1%)
Serious adverse event*	17 (19%)	16 (18%)	16 (18%)
Adverse event leading to participant withdrawing from the trial	4 (4%)	2 (2%)	2 (2%)
Medically attended adverse event	21 (23%)	29 (33%)	21 (24%)
Death†	4 (4%)	2 (2%)	2 (2%)

^*No serious adverse events were deemed to be at least possibly related to vaccination.

^†See appendix for details of deaths.