Trial Information
Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result
Inclusion Criteria:
- Females aged 12-26 years
- Have been diagnosed by a specialist with one of the six chronic medical conditions
described:
1. Paediatric Rheumatological Disease
2. Inflammatory Bowel Disease
3. Acute Lymphoblastic Leukaemia
4. Solid Organ Transplant Recipients (kidney and liver)
5. Chronic Renal Disease
6. Bone Marrow Transplant
Exclusion Criteria:
- Previous immunisation with HPV vaccine Recognised contraindication to the receipt of
the vaccine e.g. anaphylaxis
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
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.
Outcome Time Frame:
One Month post HPV vaccination
Safety Issue:
Yes
Principal Investigator
Jim Buttery
Investigator Role:
Principal Investigator
Investigator Affiliation:
NHMRC CCRE in Childhood and Adolescent Immunisation
Authority:
Australia: National Health and Medical Research Council
Study ID:
RCH CA27091
NCT ID:
NCT00964210
Start Date:
March 2008
Completion Date:
April 2011
Related Keywords:
- Cervical Cancer
- Juvenile Idiopathic Arthritis
- Inflammatory Bowel Disease
- Acute Lymphoblastic Leukemia
- Chronic Renal Disease
- Solid Organ Transplant
- Uterine Cervical Neoplasms
- Papilloma