Table 4.

Overall summary of adverse events

	Statistics	Test Vaccine(N = 240)	Reference Vaccine(N = 240)	Total(N = 480)
Number of Participants Without Any TEAE	n (%)	238 (99.2%)	239 (99.6%)	477 (99.4%)
Number of Participants With at Least One TEAE	n (%) E	2 (0.8%) 2	1 (0.4%) 1	3 (0.6%) 3
Number of Participants With at Least One Severe TEAE	n (%) E	0	0	0
Number of Participants With at Least One TEAE with a Reasonable Possibility for a Causal Relationship	n (%) E	0	0	0
Number of Participants With at Least One SAE	n (%) E	0	0	0
Number of Participants With at Least One TEAE Leading to Study Termination	n (%) E	0	0	0
Number of Participants With at Least One TESAE	n (%) E	0	0	0
Number of Deaths	n (%) E	0	0	0
Number of TE Deaths	n (%) E	0	0	0

Abbreviation:TE: Treatment emergent, TEAE: Treatment emergent adverse event

Notes: n: Number of participants, E: Number of events

Percentages are based on the number of participants in the safety participant sample.

A TEAE is defined as an AE that started or worsened in severity on or after the first study vaccination.

TEAEs leading to study termination are TEAEs reported on the Adverse Event Case report form (CRF) with “Led to Study Termination” = ‘yes’.

Severe = severity reported as severe or missing.

Reasonable possibility for a causal relationship = drug-event relationship reported as possible, probable or missing.

[TE] Death is defined as a fatal outcome of a [TE](S)AE.