114101 - Post-marketing safety study to assess the risk of spontaneous abortions in women exposed to Cervarix in the United Kingdom

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BM02) papillomavirus (human types 16, 18)
• Medical condition to be studied:
  Human papilloma virus immunisation

Population studied

• Short description of the study population:
  Pregnant women were defined based on exposure to Cervarix as recorded in the CPRD GOLD.; 1. The exposed cohort included women with the first day of LMP: between 30 days before and 45 days after any Cervarix dose, as requested by the FDA, and between 30 days before and 90 days after any Cervarix dose, as defined in the study EPIHPV-020 and as used for the pooled analysis by Wacholder; 2. The non-exposed cohort included women with the first day of LMP between 120 days and 18 months after their last Cervarix dose (and no further Cervarix dose before the outcome)
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1046

Study design details

• Main study objective:
  To assess the risk of spontaneous abortion during weeks 1 to 23 of gestation (UK definition) in women aged 15 to 25 years with the first day of last menstrual period (LMP) between 30 days before and 45 days after any dose of Cervarix.
• Outcomes:
  Occurrence of spontaneous abortion during weeks 1-23 of gestation, Occurrence of spontaneous abortion during weeks 1-19 of gestation,Occurrence of other pregnancy outcomes up to 12 months after last menstrual period,Baby’s death in the first 12 weeks of life.
• Data analysis plan:
  The primary analysis will be the comparison of the risk of spontaneous abortion during the first 23 weeks of gestation and during the first 19 weeks of gestation in the exposed cohort and the non-exposed cohort using a Cox regression model with spontaneous abortion as the dependent variable, a dichotomous exposure as the independent variable and with age at first day of gestation as a covariate. The hazard ratio and its 95% confidence interval (CI) will be derived. The analysis will be done for two risk periods for the exposed subjects: the 30 days before to 45 days after any dose of Cervarix period and the 30 days before to 90 days after any dose of Cervarix period.For subjects with no spontaneous abortion, time-to-event will be censored at: the end of week 23 (or week 19), date of induced or therapeutic abortion, date of death, date of last available pregnancy data whichever occurs first.

Documents

Study results

114101-Clinical-Study-Report-Redact-V1