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

This study has been terminated.
(Low accrual of subjects primarily attributable to the low uptake of Cervarix in the US and Canada in women aged 15 to 25 years of age.)
Sponsor:
Collaborator:
The Organization of Teratology Information Specialists
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01290393
First received: February 3, 2011
Last updated: May 2, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Spontaneous Abortions
 Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Safety Study to Assess the Risk of Spontaneous Abortion Following Administration of CERVARIX in the United States and Canada

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of other adverse pregnancy outcomes [ Time Frame: This outcome measure will be recorded between zero and six weeks after end of pregnancy ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 Other: Data collection
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.
 Other: Data collection
Data collection from hard copy interview forms routinely used by the Organization of Teratology Information Specialists (OTIS).

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.

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290393

Sponsors and Collaborators
GlaxoSmithKline
The Organization of Teratology Information Specialists
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01290393     History of Changes
Other Study ID Numbers: 114176
Study First Received: February 3, 2011
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
vaccine
Spontaneous abortions
Human papillomavirus
 HPV
Cervarix
pregnancy

Additional relevant MeSH terms:
Abortion, Spontaneous
Pregnancy Complications

ClinicalTrials.gov processed this record on June 18, 2013