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

Stopped early

Conditions studied: Infections, Papillomavirus

In brief

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.

Key facts

Study ID

NCT01290393

Run by

GlaxoSmithKline

People needed

2

Starts

2011-09-26

Expected to finish

2012-12-20

Last updated by the study team

2018-07-26

Who can join

Age: 15 and older, up to 25. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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