Advertisement

Topics

A Study of Gardasil (V501) in Preadolescents and Adolescents

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

Summary

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).

Description

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

Conditions

Healthy Papillomavirus Infections

Intervention

V501, Comparator: Placebo, V501

Status

Active, not recruiting

Source

Merck

Results (where available)

View Results

Links

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

Clinical Trials [2017 Associated Clinical Trials listed on BioPortfolio]

V501 Efficacy Study in Women Aged 18 to 26

A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women

A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501) in Women (V501-019)

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...

V501 Immunogenicity Study in Females Age 9 to 17 Years

The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females

Human Papillomavirus (HPV) Registration Study (Gardasil)

This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.

Safety and Tolerability Study of V501 in Japanese Boys (V501-200)

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...

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.

More From BioPortfolio on "A Study of Gardasil (V501) in Preadolescents and Adolescents"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...


Searches Linking to this Trial