Table 3.
Summary of safety and pregnancy outcomes from Month 0 to Month 60 (total vaccinated cohort; irrespective of serostatus and DNA status prior to vaccination)
| HPV-16/18 vaccine [N = 553] | HPV-6/11/16/18 vaccine [N = 553] | |
|---|---|---|
| Safety Outcomes | ||
| Number of subjects with safety outcomes | ||
| Serious adverse event, n (%) [95% CI] | 44 (8.0) [5.8, 10.5] | 37 (6.7) [4.8, 9.1] |
| Medically significant condition, n (%) [95% CI] | 259 (46.8) [42.6, 51.1] | 226 (40.9) [36.7, 45.1] |
| New onset chronic disease, n (%) [95% CI] | 39 (7.1) [5.1, 9.5] | 43 (7.8) [5.7, 10.3] |
| New onset autoimmune disease, n (%) [95% CI] | 7 (1.3) [0.5, 2.6] | 13 (2.4) [1.3, 4.0] |
| Pregnancy Outcomes | ||
| Number of subjects with pregnancies | 96 | 76 |
| Live infant NO apparent congenital anomaly, n (%) | 69 (71.9) | 56 (73.7) |
| Live infant congenital anomaly, n (%) | 0 | 2 (2.6) |
| Elective termination NO apparent congenital anomaly, n (%) | 6 (6.3) | 3 (3.9) |
| Ectopic pregnancy, n (%) | 1 (1.0) | 0 |
| Spontaneous abortion NO apparent congenital anomaly, n (%) | 15 (15.6) | 11 (14.5) |
| Stillbirth NO apparent congenital anomaly, n (%) | 1 (1.0) | 0 |
| Lost to follow-up, n (%) | 2 (2.1) | 3 (3.9) |
| Pregnancy ongoing, n (%) | 2 (2.1) | 1 (1.3) |
95% CI, exact 95% confidence interval; N, number of subjects with at least one administered dose; n (%), number (percentage) of subjects with event. Medically significant conditions were adverse events prompting an emergency room or physician visit that were not related to common diseases. As described previously2, all adverse events reported during the trial were compared with a pre-defined list of potential chronic diseases derived from the Medical Dictionary for Regulatory Activities. Determination of whether a chronic disease was of new onset was based on blinded review of the reported symptoms and the subject's pre-vaccination medical history by a physician from GlaxoSmithKline. A separate list, restricted to potential autoimmune events which excluded allergy-related events or isolated signs and symptoms and events not considered to be autoimmune in origin, was used to identify new onset autoimmune diseases among events identified as new onset chronic diseases.