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

NCT01905462 | Completed

• 1 other identifier: 114101
• Study Type: observational
• Target: 1,046
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infections, Papillomavirus

Keywords

Cervarix; Spontaneous abortion; Vaccine; Human Papillomavirus

Outcome Measures

Primary Outcomes (1)

• Occurrence of spontaneous abortion

  Weeks 1-23 of gestation

Secondary Outcomes (3)

• Occurrence of spontaneous abortion

  Weeks 1-19 of gestation

• Occurrence of other pregnancy outcomes

  12 months after last menstrual period

• Baby's death

  First 12 weeks of baby's life

Study Arms (2)

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; Biological: Cervarix

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; Biological: Cervarix

Interventions

Data Collection OTHER

Analyses of data collected within the CPRD GOLD database.

Exposed cohort; Non-exposed cohort

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.

Exposed cohort; Non-exposed cohort

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Clinical Practice Research Datalink: collaborator

Study Sites (1)

GSK Investigational Site

London, SW1W 9SZ, United Kingdom

Location

MeSH Terms

Conditions

Papillomavirus Infections; Abortion, Spontaneous

Interventions

Data Collection; human papillomavirus vaccine, L1 type 16, 18

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: November 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 30, 2013

Record last verified: 2013-09

Locations

GB (1)