Table 4.
Safety and pregnancy outcomes at the time of event-triggered final analysis (TVC)
| Vaccine N = 3026 | Control N = 3025 | |
|---|---|---|
| Unsolicited symptoms within 30 days postvaccination, n (%) | ||
| Any | 793 (26.2) | 775 (25.6) |
| Grade 3 | 18 (0.6) | 18 (0.6) |
| Related to vaccination1 | 35 (1.2) | 32 (1.1) |
| Serious and other significant adverse events, n (%) | ||
| Serious adverse events | 29 (1.0) | 55 (1.8) |
| Number of serious adverse events | 36 | 57 |
| Number of serious adverse events related to vaccination1 | *1* | *1* |
| Fatal adverse events | *1* | *1* |
| Adverse events leading to premature discontinuation | 5 (0.2) | 4 (0.1) |
| Medically significant conditions | 158 (5.2) | 156 (5.2) |
| New onset chronic diseases | 8 (0.3) | 11 (0.4) |
| New onset autoimmune diseases | 2 (0.1) | 2 (0.1) |
| Pregnancy outcomes, n (%) | ||
| Live infant: no apparent congenital anomaly | 106 (56.4) | 124 (54.1) |
| Live infant: congenital anomaly2 | *1* | *1* |
| Elective termination: no apparent congenital anomaly | 41 (21.8) | 65 (28.4) |
| Elective termination: congenital anomaly2 | *1* | *1* |
| Spontaneous abortion: no apparent congenital anomaly | 7 (3.7) | 9 (3.9) |
| Still birth: no apparent congenital anomaly | *1* | *1* |
| Ectopic pregnancy | 4 (2.1) | 6 (2.6) |
| Pregnancy ongoing | 27 (14.4) | 23 (10.0) |
N: number of evaluable women in each group; n (%): number (percentage) of subjects with the event.
*n*: number present in one group only and duplicated to avoid unblinding of ongoing study.
1
Assessed as causally related by the investigator.
2
The congenital anomalies for the live births were acleistocardia, congenital muscular torticollis and cleft lip and palate. The congenital anomaly for the elective termination was cyst on head and hydrocephalus.