Table 2.
Adverse events
| Patients in population | Two doses of V935 (low dose) | Three doses of V934 and two doses of V935 (low dose) | Two doses of V935 (high dose) | Three doses of V934 and two doses of V935 (high dose) | Five doses of V934 and two doses of V935 (high dose) | Total |
|---|---|---|---|---|---|---|
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
| With follow-up | 3 (100.0) | 3 (100.0) | 10 (100.0) | 11 (100.0) | 10 (100.0) | 37 (100.0) |
| With one or more adverse events | 3 (100.0) | 3 (100.0) | 8 (80.0) | 11 (100.0) | 10 (100.0) | 35 (94.6) |
| Injection-site | 1 (33.3) | 2 (66.7) | 3 (30.0) | 10 (90.9) | 10 (100.0) | 26 (70.3) |
| Non-injection-site | 3 (100.0) | 2 (66.7) | 8 (80.0) | 10 (90.9) | 10 (100.0) | 33 (89.2) |
| With no adverse event | 0 (0.0) | 0 (0.0) | 2 (20.0) | 0 (0.0) | 0 (0.0) | 2 (5.4) |
| With vaccine-relateda adverse events | 2 (66.7) | 3 (100.0) | 4 (40.0) | 11 (100.0) | 10 (100.0) | 30 (81.1) |
| Injection site | 1 (33.3) | 2 (66.7) | 3 (30.0) | 10 (90.9) | 10 (100.0) | 26 (70.3) |
| Non-injection site | 1 (33.3) | 1 (33.3) | 1 (10.0) | 5 (45.5) | 5 (50.0) | 13 (35.1) |
| With serious adverse events | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (18.2) | 1 (10.0) | 3 (8.1) |
| With serious vaccine-related adverse events | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Who died | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Discontinuedb due to an adverse event | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Discontinued due to a vaccine-related adverse event | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Discontinued due to a serious adverse event | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Discontinued due to a serious vaccine-related adverse event | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
aDetermined by the investigator to be related to the vaccine
bStudy medication withdrawn