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GARDASIL™ Vaccine Impact in Population Study

2014-08-27 03:15:35 | BioPortfolio

Summary

This study will assess the impact of GARDASIL™ in the general female population by utilizing nationwide registry databases in the participating Nordic countries.

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.

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.

Study Design

Observational Model: Ecologic or Community

Conditions

Human Papillomavirus Infections

Status

Active, not recruiting

Source

Merck

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:35-0400

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Medical and Biotech [MESH] Definitions

A type of human papillomavirus especially associated with malignant tumors of the genital and RESPIRATORY MUCOSA.

Vaccines or candidate vaccines used to prevent PAPILLOMAVIRUS INFECTIONS. Human vaccines are intended to reduce the incidence of UTERINE CERVICAL NEOPLASMS, so they are sometimes considered a type of CANCER VACCINES. They are often composed of CAPSID PROTEINS, especially L1 protein, from various types of ALPHAPAPILLOMAVIRUS.

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Respiratory and conjunctival infections caused by 33 identified serotypes of human adenoviruses.

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