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Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females

NCT00693615 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-09-16

No results posted yet for this study

Summary

The goals of this study are to describe the safety, reactogenicity and immunogenicity of MEDI-517 with and without adjuvant in HPV-naïve humans. Long-term immune data is collected.

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

IM injection

BIOLOGICAL

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

IM injection

BIOLOGICAL

MEDI-517 HPV-16/18 VLP vaccine without adjuvant

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
2000-10-31
Primary Completion
2005-01-31
Completion
2005-01-31

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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 NCT00693615 on ClinicalTrials.gov