Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT00693966
Brief Summary:
The purpose of this Phase II study is to provide data regarding the safety and immunogenicity for a range of dose levels of MEDI-517 in women who are HPV-16/18 seronegative and negative for high-risk HPV DNA. The study is designed to evaluate safety and immunogenicity data for MEDI-517 when formulated with either AS04 or aluminum hydroxide. Extended follow-up will provide long-term immune response data.
This study was originally performed by MedImmune. However, GSK is now responsible for the clinical development of the HPV vaccine.
Detailed Description:
This is a Phase II double-blind, randomized, dose-comparison, multicenter study in the United States of three different dose levels of MEDI-517 (HPV-16/18 VLP AS04 vaccine) and one dose of MEDI-517 formulated with aluminum hydroxide, with doses administered at 0, 30 and 180 days. Healthy female volunteers 18 through 30 years of age will be entered into 4 treatment arms. The objectives of study are to evaluate reactogenicity, safety and immunogenicity.
Study:
NCT00693966
Study Brief:
Protocol Section:
NCT00693966