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

September 26, 2013 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1046

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW1W 9SZ
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of spontaneous abortion
Time Frame: Weeks 1-23 of gestation
Weeks 1-23 of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of spontaneous abortion
Time Frame: Weeks 1-19 of gestation
Weeks 1-19 of gestation
Occurrence of other pregnancy outcomes
Time Frame: 12 months after last menstrual period
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.
12 months after last menstrual period
Baby's death
Time Frame: First 12 weeks of baby's life
First 12 weeks of baby's life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Clinical Practice Research Datalink

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Estimate)

September 30, 2013

Last Update Submitted That Met QC Criteria

September 26, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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