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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.
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
Published on BioPortfolio: 2014-08-27T03:54:03-0400
A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women
This study is to assess the tolerability and efficacy of a vaccine being evaluated to reduce the incidence of human papillomavirus (HPV) infection and disease (external genital warts and v...
The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females
This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.
This is a study of V501 [quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1 Virus-Like Particle (VLP) vaccine] in healthy Japanese boys. This study will consist of two peri...
To evaluate the validity and acceptability of at-home self-collection to test for high-risk human papillomavirus (HPV) and sexually transmitted infections among women overdue for cervical cancer scree...
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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