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Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result


Phase 3
12 Years
26 Years
Not Enrolling
Female
Cervical Cancer

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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

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