Post-marketing Study to Assess the Safety of CERVARIX When Used in the United States and in Canada

July 25, 2018 updated by: GlaxoSmithKline

Post-marketing Safety Study to Assess the Risk of Spontaneous Abortion Following Administration of CERVARIX in the United States and Canada

This study will assess the risk of spontaneous abortion during weeks 1-19 of gestation, and other pregnancy outcomes, in an Exposed vaccinated cohort, i.e. women with last menstrual period between 30 days before and 90 days after any dose of CERVARIX, when compared to a Non-exposed vaccinated cohort, i.e. women with last menstrual period between 120 days and 18 months after the last CERVARIX or GARDASIL dose.

Study Overview

Status

Terminated

Intervention / Treatment

Detailed Description

The present study will be conducted by the OTIS (Organization of Teratology Information Specialists) network. OTIS is a non-profit organization specialised to assess exposures during pregnancy and dedicated to providing accurate evidence-based, clinical information to patients and health care professionals about exposures during pregnancy and lactation. OTIS is based on voluntary phone calls. Women call when they have questions and concerns about risks potentially associated with any kind of exposure during pregnancy or breastfeeding, including medications, chemicals, pesticides, diseases, infections, and vaccinations.

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92123
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged 15 to 25 years and residing in the United States or in Canada

Description

Inclusion Criteria:

For Exposed vaccinated cohort:

  • Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
  • Aged between, and including, 15 and 25 years of age.
  • Residing within the US or Canada.
  • Subjects who received at least one dose of CERVARIX.
  • Gestational age at inclusion should be 19 completed weeks (i.e. 133 days of gestation) or less.
  • Last menstrual period between 30 days before and 90 days after any dose of CERVARIX with a maximum of 20% of subjects with last menstrual period between 46 and 90 days after any dose of CERVARIX.
  • Subjects who the Investigator believes can and will comply with the requirements of the protocol (e.g. available for phone interviews). Or subjects who the Investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.

For Non-exposed vaccinated cohort:

  • Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
  • Aged between, and including, 15 and 25 years of age.
  • Residing within the US or Canada.
  • Subjects who received at least one dose of CERVARIX or at least one dose of GARDASIL.
  • Gestational age at inclusion should be 19 completed weeks (i.e. 133 days of gestation) or less.
  • Last menstrual period between 120 days and 18 months after the last dose of CERVARIX/ GARDASIL.
  • Subjects who the Investigator believes can and will comply with the requirements of the protocol (e.g. available for phone interviews). Or subjects who the Investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.

Exclusion Criteria:

For Exposed vaccinated cohort:

  • Last menstrual period between 30 days before and 90 days after any GARDASIL dose.
  • Ongoing pregnancy with foetus known to be non-viable.
  • Ongoing pregnancy with pre-enrolment knowledge by prenatal diagnosis of a major structural defect.
  • Use of any investigational or non-registered product (drug or vaccine) during the study period.

For Non-exposed vaccinated cohort:

  • Ongoing pregnancy with foetus known to be non-viable.
  • Ongoing pregnancy with pre-enrolment knowledge by prenatal diagnosis of a major structural defect.
  • Use of any investigational or non-registered product (drug or vaccine) during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed vaccinated cohort
Women with last menstrual period between 30 days before and 90 days after any CERVARIX dose. The target sample size of the Exposed vaccinated cohort is 150 subjects.
Data collection from hard copy interview forms routinely used by the Organization of Teratology Information Specialists (OTIS).
Non-exposed vaccinated cohort
Women with last menstrual period between 120 days and 18 months after the last CERVARIX or GARDASIL dose. The target sample size of the Non-exposed vaccinated cohort is 300 subjects.
Data collection from hard copy interview forms routinely used by the Organization of Teratology Information Specialists (OTIS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of spontaneous abortion during weeks 1-19 of gestation
Time Frame: This outcome measure will be recorded between zero and six weeks after end of pregnancy
This outcome measure will be recorded between zero and six weeks after end of pregnancy

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of other adverse pregnancy outcomes
Time Frame: This outcome measure will be recorded between zero and six weeks after end of pregnancy
This outcome measure will be recorded between zero and six weeks after end of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2011

Primary Completion (Actual)

December 20, 2012

Study Completion (Actual)

December 20, 2012

Study Registration Dates

First Submitted

February 3, 2011

First Submitted That Met QC Criteria

February 3, 2011

First Posted (Estimate)

February 7, 2011

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 25, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114176

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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