Table 5.

On-treatment safety and tolerability

Adverse events	V1: vaccine vs. placebo N (%) p*	V2: vaccine vs. placebo N (%) p*	V3: vaccine vs. placebo N (%) p*
Total AE	36 (54.4) vs. 55 (87.3) 0.0001	59 (89.4) vs. 62 (98.4) 0.06	44 (66.7) vs. 57 (91.9) 0.0001
Injection-site pain	37 (56.1) vs. 53 (83.6) 0.0001	58 (87.8) vs. 62 (98.4) 0.0001	45 (67.7) vs. 57 (91.9) 0.0001
Local itching	10 (15.1) vs. 5 (8) 0.13	1 (1.5) vs. 1 (1.6) 0.37	1 (1.5) vs. 0 0.33
Syncope	2 (3) vs. 0 0.5	1 (1.5) vs. 0 0.33	1 (1.5) vs. 0 0.33
AE leading to treatment discontinuation	0 vs. 0	0 vs. 0	0 vs. 0
Deaths	0 vs. 0	0 vs. 0	0 vs. 0
Serious AE	0 vs. 0	0 vs. 0	0 vs. 0
Grade 3 or 4 abnormalities	0 vs. 0	0 vs. 0	0 vs. 0

Treatment-emergent grade 3 or 4 abnormalities defined by laboratory values: ALT >5.0 × upper limit of normal (ULN); AST >5.0 × ULN; total bilirubin >2.5 × ULN

* p < 0.05