A Study of Gardasil (V501) in Preadolescents and Adolescents

2014-08-27 03:54:03 | BioPortfolio


This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).


The original base protocol (V501-018)(NCT00092547) was extended in amendments 05 and 06 to provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the base study were given 3 doses of open-label GARDASIL™ (V501) at Months 30, 32, and 36.

The study was extended again in amendment V501-018-10(NCT00092547) to allow a follow-up period to Month 126.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Healthy Papillomavirus Infections


V501, Comparator: Placebo, V501


Active, not recruiting



Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:54:03-0400

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Medical and Biotech [MESH] Definitions

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.

ONCOGENE PROTEINS from papillomavirus that deregulate the CELL CYCLE of infected cells and lead to NEOPLASTIC CELL TRANSFORMATION. Papillomavirus E7 proteins have been shown to interact with various regulators of the cell cycle including RETINOBLASTOMA PROTEIN and certain cyclin-dependent kinase inhibitors.

A type of XIPAPILLOMAVIRUS causing alimentary carcinoma in cattle. It is related to Bovine papillomavirus 3.

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

Neoplasms of the skin and mucous membranes caused by papillomaviruses. They are usually benign but some have a high risk for malignant progression.

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