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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00911521 |
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Date of registration:
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28/05/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled Study
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Scientific title:
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Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus (SLE): a Controlled Study |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00911521 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Chi Chiu Mok, MD, FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tuen Mun Hospital, Hong Kong, China |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
SLE patients
- Female patients aged = 35 years
- Fulfilling the American College of Rheumatology (ACR) criteria for the classification
of SLE
- Having received a stable dose of prednisolone and/or other immunosuppressive agents
within 3 months of study entry
- Able to give written informed consent
Controls
- Women aged = 35 years, matched those of SLE patients recruited
- No known chronic medical diseases
- Not receiving any long-term medications including herbs
Exclusion Criteria:
- History of allergy to HPV vaccines
Age minimum:
N/A
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: human papillomavirus vaccination (Gardasil)
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Primary Outcome(s)
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antibody titers against 4 strains of human papillomavirus
[Time Frame: baseline, month 7 and month 12]
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Secondary ID(s)
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NTWC/CREC/704/09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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