Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women

Completed · Not applicable

Conditions studied: Systemic Lupus Erythematosus

In brief

The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.

Key facts

Study ID

NCT00786409

Run by

University of Chicago

People needed

27

Starts

2008-11-01

Expected to finish

2011-12-01

Last updated by the study team

2018-02-15

Who can join

Age: 9 and older, up to 26. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age: 9 to 26 years of age
• Gender: Female
• All patients must fulfill the revised American College of Rheumatology Classification Criteria for SLE diagnosis.
• Current SLEDAI score ≤ 6
• Written, witnessed informed consent and/or assent will be obtained from the subject and the subject's parents (if under 18 years of age) or legally acceptable representative prior to enrollment

You may not qualify if…

• Acute exacerbation of disease within past 30 days which required increase in corticosteroid dose, initiation of a new immunosuppressive medication, or hospitalization
• Current SLEDAI score > 6
• Patients who have received rituximab in the last 6 months, or are currently on cyclophosphamide treatment
• History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine
• Previous administration of any HPV vaccine

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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