Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix Residing in UK
NCT ID: NCT01905462
Last Updated: 2013-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1046 participants
OBSERVATIONAL
2012-11-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
Data Collection
Analyses of data collected within the CPRD GOLD database.
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).
Data Collection
Analyses of data collected within the CPRD GOLD database.
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.
Interventions
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Data Collection
Analyses of data collected within the CPRD GOLD database.
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.
Eligibility Criteria
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Inclusion Criteria
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
• 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.
15 Years
25 Years
FEMALE
Yes
Sponsors
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Clinical Practice Research Datalink
OTHER_GOV
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
London, , United Kingdom
Countries
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Other Identifiers
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114101
Identifier Type: -
Identifier Source: org_study_id