Trials / Completed
CompletedNCT01077856
GARDASIL™ Vaccine Impact in Population Study (V501-033)
GARDASIL™ Vaccine Impact in Population Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 54,516 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2007-05-29
- Primary completion
- 2014-12-02
- Completion
- 2014-12-02
- First posted
- 2010-03-01
- Last updated
- 2022-09-13
- Results posted
- 2015-12-10
Source: ClinicalTrials.gov record NCT01077856. Inclusion in this directory is not an endorsement.