GARDASIL™ Vaccine Impact in Population Study (V501-033)
GARDASIL™ Vaccine Impact in Population Study (V501-033)
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.
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.
Inclusion Criteria: - Registry Data: * Female residents of participating Nordic countries
 who were alive on January 1st in the year the data will be used for analysis - Survey Data:
 --Female residents alive in the participating countries on July 1, 2011 --Women must
 provide consent to use questionnaire data and to link data to other registry databases -
 Cervical Sample Collection: --For HPV data in the general population: cervical samples from
 residents of the participating countries who are 45 years and under collected between 2006
 and 2007, or in 2011-2012 --For HPV data in lesional samples: cervical samples from women
 with a diagnosis of CIN or cervical cancer between 2004-2006 and 2011-2012 Exclusion
 Criteria: - Registry Data: * Women who participated in Protocol V501-015 (NCT00092534) and
 are included in the Long-Term Follow-Up study - Survey Data: --Women under 18 or above age
 45 on July 1, 2011 --Women who participated in Protocol V501-015 and are included in the
 Long-Term Follow-Up study - Cervical Sample Collection: --Samples from women who
 participated in Protocol V501-015 and are included in the Long-Term Follow-Up study
 --Samples with inadequate integrity for HPV testing