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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infections, Papillomavirus

Intervention / Treatment
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* Other: Data Collection
* Biological: Cervarix


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed cohort<br>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<br>* Analyses of data collected within the CPRD GOLD database.<br>Biological: Cervarix<br>* 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.<br>|
| Non-exposed cohort<br>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<br>* Analyses of data collected within the CPRD GOLD database.<br>Biological: Cervarix<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of spontaneous abortion |  | Weeks 1-19 of gestation | 
| Occurrence of other pregnancy outcomes | 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 |  | First 12 weeks of baby's life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervarix, Spontaneous abortion, Vaccine, Human Papillomavirus