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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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31 October 2016 |
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Main ID: |
NCT02477254 |
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Date of registration:
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17/06/2015 |
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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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Long-term Immunogenicity of a HPV Vaccine in SLE
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Scientific title:
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Long-term Immunogenicity of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus: a Case-control Study |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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84 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02477254 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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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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CC Mok, MD |
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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 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
SLE patients
1. Female patients aged 18-35 years
2. Fulfilling the American College of Rheumatology (ACR) criteria for the classification
of SLE
3. Having participated in the investigators' original HPV study in 2010
4. Able to give written informed consent
Controls
1. Women aged 18-35 years, matched those of SLE patients recruited
2. No known chronic medical diseases
3. Having participated in our HPV study in 2010
Age minimum:
18 Years
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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Biological: Vaccination
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Primary Outcome(s)
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Neutralizing antibodies to HPV serotypes 6,11,16 and 18
[Time Frame: 5 years]
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Secondary Outcome(s)
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Neutralizing antibodies to HPV serotypes 6,11,16 and 18
[Time Frame: 5 years]
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Secondary ID(s)
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NTWC/CREC/15035
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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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