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Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females

NCT00693966 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2016-09-16

No results posted yet for this study

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.

Conditions

  • Infections, Papillomavirus

Interventions

BIOLOGICAL

MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)

IM injection

BIOLOGICAL

MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2)

IM injection

BIOLOGICAL

MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3)

IM injection

BIOLOGICAL

MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)

IM injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-10-31
Primary Completion
2004-09-30
Completion
2004-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00693966 on ClinicalTrials.gov