GARDASIL™ Vaccine Impact in Population Study
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.
Enrollment/Sample Size: Registry Data: All appropriate data will be used; Survey Data: for
each country: 14,000; HPV Data: 2,500 cervical swab samples and 500 tissue samples.
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.
Observational Model: Ecologic or Community
Incidence of histologically confirmed cervical intraepithelial neoplasia (CIN)
2004-2006 and 2011-2012
Norway: Norwegian Medicines Agency