A Phase 3 interventional study of Licensed quadrivalent HPV vaccine, Gardasil in Cervical Cancer, sponsored by Murdoch Childrens Research Institute. Completed at 1 site in Australia. Open to female participants aged 12 Years to 26 Years. Per ClinicalTrials.gov, last updated 2011-04-15.
Sponsored by Murdoch Childrens Research Institute · Phase 3, Interventional, and Prevention
A research project is currently being undertaken looking at Human Papilloma Virus (HPV) vaccination in special risk groups. It aims to see if young women with a chronic illness respond well to the HPV vaccine or whether they may require additional doses to ensure protective immunity. The four valent HPV vaccine protects against HPV types 16 \& 18, cervical cancer and HPV types 6 \& 11, anogenital warts.
The six special risk groups include:
Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow Transplants This immunity is measured by antibody levels of the HPV types, which requires a single blood test one month after the final dose of HPV vaccine.
This is compared to healthy controls using antibody response to HPV vaccine. This will assess directly whether these special risk groups respond as well to the HPV vaccine.
1,879 studies on the registry are indexed under Uterine Cervical Neoplasms; 565 are open to participants now.
This study's planned enrollment of 240 is above the median of 100 across 1,375 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Murdoch Childrens Research Institute is the lead sponsor of 96 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Have been diagnosed by a specialist with one of the six chronic medical conditions described:
Exclusion Criteria:
The dose of the four valent (4v) HPV vaccine is 0.5ml administered by intramuscular (IM)injection. The recommended schedule is 0, 2 and 6 months.
Determine the HPV vaccine immunogenicity in females 12-26 years with six special risk groups at one month post the third and final HPV vaccination. Blood analysis taken at one month post third and final HPV vaccine to assess immunogenicity.
Time frame: One Month post HPV vaccination
Describe the safety of the HPV vaccine in the six study groups using self reports and liaison with treating sub specialist team.
Time frame: One month post third HPV vaccination
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Murdoch Childrens Research Institute