We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01290393
Recruitment Status : 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.)
First Posted : February 7, 2011
Last Update Posted : May 6, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Spontaneous Abortions Other: Data collection

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 Design

Study Type : Observational
Actual Enrollment : 2 participants
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
Study Start Date : September 2011
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage
U.S. FDA Resources

Groups and Cohorts

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.
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).


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Occurrence of other adverse pregnancy outcomes [ Time Frame: This outcome measure will be recorded between zero and six weeks after end of pregnancy ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290393


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01290393     History of Changes
Other Study ID Numbers: 114176
First Posted: February 7, 2011    Key Record Dates
Last Update Posted: May 6, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Abortion, Spontaneous
Pregnancy Complications