Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix Residing in UK

This study has been completed.
Sponsor:
Collaborator:
Clinical Practice Research Datalink General Practitioner OnLine Database
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01905462
First received: July 18, 2013
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Infections, Papillomavirus
Other: Data Collection
Biological: Cervarix

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix in the United Kingdom

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of spontaneous abortion [ Time Frame: Weeks 1-23 of gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of spontaneous abortion [ Time Frame: Weeks 1-19 of gestation ] [ Designated as safety issue: No ]
  • Occurrence of other pregnancy outcomes [ Time Frame: 12 months after last menstrual period ] [ Designated as safety issue: No ]
    Induced/therapeutic and other abortions; Stillbirth; Birth defects identified among all pregnancies with known outcome classified as live births, stillbirths and abortions. For live births, birth defects identified within the first 12 weeks of life will be included; Small/large for gestational age at birth; Pre-term and post-term delivery.

  • Baby's death [ Time Frame: First 12 weeks of baby's life ] [ Designated as safety issue: No ]

Enrollment: 1046
Study Start Date: November 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Exposed cohort
Women with the first day of LMP between 30 days before and 45 days after any Cervarix dose and between 30 days before and 90 days after any Cervarix dose.
Other: Data Collection
Analyses of data collected within the CPRD GOLD database.
Biological: Cervarix
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 and women with LMP between 120 days and 18 months after the last Cervarix dose.
Non-exposed cohort
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).
Other: Data Collection
Analyses of data collected within the CPRD GOLD database.
Biological: Cervarix
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 and women with LMP between 120 days and 18 months after the last Cervarix dose.

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

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01905462

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, SW1W 9SZ
Sponsors and Collaborators
GlaxoSmithKline
Clinical Practice Research Datalink General Practitioner OnLine Database
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01905462     History of Changes
Other Study ID Numbers: 114101
Study First Received: July 18, 2013
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: European Medicines Agency

Keywords provided by GlaxoSmithKline:
Cervarix
Spontaneous abortion
Vaccine
Human Papillomavirus

Additional relevant MeSH terms:
Abortion, Spontaneous
Pregnancy Complications

ClinicalTrials.gov processed this record on April 16, 2014