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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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6 October 2015 |
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Main ID: |
NCT02276521 |
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Date of registration:
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21/10/2014 |
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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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Evaluation of Long Term Immunity Following HPV Vaccination
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Scientific title:
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Evaluation of Long-term Immunological Responses Following Reduced Dose Quadrivalent Human Papillomavirus (HPV) Vaccine Schedules: A Phase II/III Clinical Trial |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02276521 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Phase:
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Countries of recruitment
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Fiji
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Contacts
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Name:
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Edward K Mulholland |
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Address:
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Telephone:
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Email:
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Affiliation:
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Murdoch Childrens Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Girls who live in Suva and were previously vaccinated with one, two or three
Gardasil® doses or were eligible but did not receive Gardasil® vaccine in the 2008/9
campaign will be eligible for the study.
Exclusion Criteria:
- Any participant who had anaphylaxis following a previous dose of the vaccine,
anaphylaxis to any vaccine component, or possible pregnancy will be excluded from
this study.
- In addition, any participant whose dates of previous Gardasil® vaccination are
uncertain, or has received Cervarix® vaccine previously, or has an axillary
temperature greater than 38°C will be excluded from this study.
Age minimum:
15 Years
Age maximum:
17 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Anogenital Warts
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Cervical Cancer
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Intervention(s)
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Biological: Cervarix®
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Primary Outcome(s)
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GMCs of HPV- specific antibody titres against HPV 6, 11, 16 and 18
[Time Frame: 6 months]
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Secondary Outcome(s)
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GMCs of HPV- specific antibody titres against HPV 6, 11, 16 and 18 one month post Cervarix®
[Time Frame: 6 months]
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Number of HPV- specific memory B- and T- cells against HPV 6, 11, 16 and 18 pre and one month post Cervarix®
[Time Frame: 11 months]
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Fold change in the gene expression profiles in immune cells both pre- and one month post Cervarix®
[Time Frame: 11 months]
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Secondary ID(s)
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2014.5.FNRERC.5.SU
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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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