TABLE 7

Summary of Outcomes of Pregnancies During Study 001

9vHPV Vaccine (n = 7092)qHPV Vaccine (n = 7093)
OverallConception DateaOverallConception Datea
Within 30 d of VaccinationNot Within 30 d of VaccinationWithin 30 d of VaccinationNot Within 30 d of Vaccination
No. of subjects with pregnancies12898511221239881172
No. of pregnanciesb14828613961459881371
No. of pregnancies with known outcomeb14598513741435871348
Live births (%)
 Number of live births/number of pregnancies with known outcome1168/1459 (80.1)42/85 (49.4)1126/1374 (82.0)1137/1435 (79.2)47/87 (54.0)1090/1348 (80.9)
  Normal1128/1459 (77.3)40/85 (47.1)1088/1374 (79.2)1101/1435 (76.7)44/87 (50.6)1057/1348 (78.4)
  Abnormal29/1459 (2.0)0/85 (0.0)29/1374 (2.1)31/1435 (2.2)2/87 (2.3)29/1348 (2.2)
   Congenital anomaly23/1459 (1.6)0/85 (0.0)23/1374 (1.7)21/1435 (1.5)1/87 (1.1)20/1348 (1.5)
   Other abnormality9/1459 (0.6)0/85 (0.0)9/1374 (0.7)11/1435 (0.8)1/87 (1.1)10/1348 (0.7)
  Unknown11/1459 (0.8)2/85 (2.4)9/1374 (0.7)5/1435 (0.3)1/87 (1.1)4/1348 (0.3)
 Method of delivery
  Cesarean342/1459 (23.4)9/85 (10.6)333/1374 (24.2)380/1435 (26.5)14/87 (16.1)366/1348 (27.2)
  Vaginal826/1459 (56.6)33/85 (38.8)793/1374 (57.7)757/1435 (52.8)33/87 (37.9)724/1348 (53.7)
Fetal loss (%)
 Number of fetal losses/number of pregnancies with known outcome291/1459 (19.9)43/85 (50.6)248/1374 (18.0)298/1435 (20.8)40/87 (46.0)258/1348 (19.1)
 Type of loss
  Ectopic pregnancy14/1459 (1.0)0/85 (0.0)14/1374 (1.0)10/1435 (0.7)1/87 (1.1)9/1348 (0.7)
  Spontaneous abortion133/1459 (9.1)17/85 (20.0)116/1374 (8.4)159/1435 (11.1)8/87 (9.2)151/1348 (11.2)
  Late fetal death4/1459 (0.3)1/85 (1.2)3/1374 (0.2)4/1435 (0.3)0/87 (0.0)4/1348 (0.3)
  Elective abortion140/1459 (9.6)25/85 (29.4)115/1374 (8.4)125/1435 (8.7)31/87 (35.6)94/1348 (7.0)
 Fetal outcome
  Normal56/1459 (3.8)11/85 (12.9)45/1374 (3.3)48/1435 (3.3)11/87 (12.6)37/1348 (2.7)
  Abnormal8/1459 (0.5)0/85 (0.0)8/1374 (0.6)4/1435 (0.3)0/87 (0.0)4/1348 (0.3)
   Congenital anomaly6/1459 (0.4)0/85 (0.0)6/1374 (0.4)3/1435 (0.2)0/87 (0.0)3/1348 (0.2)
   Other abnormality2/1459 (0.1)0/85 (0.0)2/1374 (0.1)1/1435 (0.1)0/87 (0.0)1/1348 (0.1)
  Unknown227/1459 (15.6)32/85 (37.6)195/1374 (14.2)246/1435 (17.1)29/87 (33.3)217/1348 (16.1)
  • n = Number of subjects as-treated who received at least 1 dose of the indicated vaccine.

  • a Conception date was calculated as date of last menstrual period plus 14 d.

  • b A subject may have >1 pregnancy during the study. Each pregnancy is counted in this summary. A pregnancy with multiple fetuses is counted as a single pregnancy, but outcome for each fetus/infant is counted individually.