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

Infections, Papillomavirus Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01290393
Study type Observational
Source GlaxoSmithKline
Contact
Status Terminated
Phase
Start date September 26, 2011
Completion date December 20, 2012
View Details
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