Table 1.

Summary of Solicited and Unsolicited Adverse Events, All Ages Combined (N = 165 Immunized Participants)

Adverse Event	All Vaccine (n = 112)		All Placebo (n = 53)
	All AEs	Possibly, Probably, or Definitely Related AEs	All AEs	Possibly, Probably, or Definitely Related AEs
Participants with at least 1 solicited AE within 7 d of immunization	40 (35.7)	30 (26.8)	22 (41.5)	19 (35.8)
Participants with a solicited grade 3 AE	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Participants with at least 1 solicited local AE	23 (20.5)	23 (20.5)	12 (22.6)	12 (22.6)
Participants with at least 1 solicited systemic AE	21 (18.8)	10 (8.9)	14 (26.4)	8 (15.1)
Participants with at least 1 unsolicited AE within 28 d of immunization	94 (83.9)	9 (8.0)	49 (92.5)	1 (1.9)
Participants with an unsolicited grade 3 AE	3 (2.7)	0 (0.0)	1 (1.9)	0 (0.0)
Participants experiencing an SAE	3 (2.7)	0 (0.0)	0 (0.0)	0 (0.0)
Total No. of SAEs (maximum severity grade)	3 (grade 3)	0 (…)	0 (…)	0 (…)

Data are presented as no. (%). Unsolicited, nonserious AEs are included in this summary if they occurred within 28 days postvaccination, but serious AEs are summarized for the duration of the study period in accordance with the protocol.

Abbreviations: AE, adverse event; SAE, serious adverse event.