Clinical trial NCT01905462: Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix Residing in UK
Official title: Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix in the United Kingdom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Papillomavirus
Keywords: Cervarix
Spontaneous abortion
Vaccine
Human Papillomavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Clinical Practice Research Datalink
First posted: 2013-07-23
Enrollment: 1046
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women aged 15 to 25 years, residing in UK, exposed to Cervarix and whose data is recorded in the CPRD GOLD.

Brief summary: This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the UK, will be analysed in this study.

Detailed description: Convenience sampling will be used in this study. It is planned to include all eligible pregnant women (included in CPRD GOLD and who fulfil to the inclusion/exclusion criteria) in each of the two cohorts.

Eligibility criteria: Inclusion Criteria:

For the exposed cohort:

All subjects must satisfy all of the following criteria at entry into the exposed cohort:

* Full date of first day of LMP available in the database or calculated from Estimated date of delivery (EDD).
* Female, aged between, and including, 15 and 25 years of age at LMP.
* Recorded in the CPRD GOLD for at least 12 months at LMP.
* First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011.
* At least one dose of Cervarix received between September 1st 2008 and June 30th 2011.
* Full date of Cervarix vaccination(s) available.
* First day of LMP available in the database or calculated from EDD between 30 days before and 90 days after any dose of Cervarix.
* Subject defined as acceptable in CPRD GOLD.

For the non-exposed cohort:

All subjects must satisfy all of the following criteria at entry into the non-exposed cohort:

* Full date of first day of LMP available in the database or calculated from EDD.
* Female, aged between, and including, 15 and 25 years of age at LMP.
* Recorded in the CPRD GOLD since at least 12 months at LMP.
* First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011.
* At least one dose of Cervarix received between September 1st 2008 and June 30th 2011.
* Full date of Cervarix vaccination(s) available.
* First day of LMP available in the database or calculated from EDD between 120 days and 18 months after the last dose of Cervarix.
* Subject defined as acceptable in CPRD GOLD.

Exclusion Criteria:

For the exposed cohort:

• Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.

For the non-exposed cohort:

* Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.
* Female included for a previous pregnancy in the exposed cohort.

Primary outcomes:
measure: Occurrence of spontaneous abortion
timeFrame: Weeks 1-23 of gestation
Secondary outcomes:
measure: Occurrence of spontaneous abortion
timeFrame: Weeks 1-19 of gestation
measure: Occurrence of other pregnancy outcomes
timeFrame: 12 months after last menstrual period
measure: Baby's death
timeFrame: First 12 weeks of baby's life
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: