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Completed

NCT Number: NCT01905462

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

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.

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Key information

Conditions

Infections, Papillomavirus Abortion, Spontaneous Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases and Pregnancy Complications Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

15 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site

London, SW1W 9SZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

Analyses of data collected within the CPRD GOLD database.

Cervarix

Biological

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.

Primary outcomes

  1. Occurrence of spontaneous abortion

    Time frame: Weeks 1-23 of gestation

Secondary outcomes

  1. Occurrence of spontaneous abortion

    Time frame: Weeks 1-19 of gestation

  2. 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.

  3. Baby's death

    Time frame: First 12 weeks of baby's life

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Clinical Practice Research Datalink

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 23, 2013
Registry last updated
Sep 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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