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

Infections, Papillomavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905462
• Other study ID #: 114101
• Status: Completed
• Phase: N/A
• First received: July 18, 2013
• Last updated: September 26, 2013
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: European Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1046
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 25 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Infections, Papillomavirus

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Clinical Practice Research Datalink

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of spontaneous abortion		Weeks 1-23 of gestation	No
Secondary	Occurrence of spontaneous abortion		Weeks 1-19 of gestation	No
Secondary	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	No
Secondary	Baby's death		First 12 weeks of baby's life	No