GARDASIL™ Vaccine Impact in Population Study
18 Years
45 Years
Female
Human Papillomavirus Infections
Trial Information
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.
Inclusion Criteria:
- Registry Data:
- Female residents of participating Nordic countries who are/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
- Subjects 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
Type of Study:
Observational
Study Design:
Observational Model: Ecologic or Community
Outcome Measure:
Incidence of histologically confirmed cervical intraepithelial neoplasia (CIN)
Outcome Time Frame:
2004-2006 and 2011-2012
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Norway: Norwegian Medicines Agency
Study ID:
2010_018
NCT ID:
NCT01077856
Start Date:
May 2007
Completion Date:
December 2014
Related Keywords:
- Human Papillomavirus Infections
- congenital anomaly
- pregnancy
- GARDASIL®
- Nordic
- population-based
- Warts
- Papillomavirus Infections
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