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Clinical Trial Summary

This study will assess the impact of GARDASIL™ human papillomavirus (HPV) vaccine in the general female population by utilizing nationwide registry databases in the participating Nordic countries.


Clinical Trial Description

Time perspective: The study will be conducted using data collected both retrospectively/concurrently from registries and prospectively by questionnaire survey. Baseline survey data were collected during a prior study from 2004-2005. Safety Monitoring: An expert panel on teratology consisting of one teratologist from each of the participating countries will review all available medical records related to any congenital anomalies to search for any emerging patterns that may be indicative of an association between GARDASIL™ exposure in the mother and the subsequent congenital anomalies in the babies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01077856
Study type Observational
Source Merck Sharp & Dohme LLC
Contact
Status Completed
Phase
Start date May 29, 2007
Completion date December 2, 2014

See also
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