Human Papilloma Virus (HPV) Vaccination in Special Risk Groups

Phase 3

Completed

• Conditions: Special Risk Groups1. Paediatric Rheumatalogical Disease2. Inflammatory Bowel Disease3. Acute Lymphoblastic Leukaemia4. Solid Organ Transplant Recipients (kidney and liver)5. Chronic Renal Disease6. Bone Marrow TranssplantThe response to the HPV vaccine will be studied within these 6 special risk groups.; Special Risk Groups; 1. Paediatric Rheumatalogical Disease; 2. Inflammatory Bowel Disease; 3. Acute Lymphoblastic Leukaemia; 4. Solid Organ Transplant Recipients (kidney and liver); 5. Chronic Renal Disease; 6. Bone Marrow Transsplant; The response to the HPV vaccine will be studied within these 6 special risk groups.; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12609000571279
• Lead Sponsor: ational Health and Medical Research Council & Clinical Centre of Research Excellence(NHMRC CCRE) in Childhood and Adolescent Immunisation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Females aged 12-26 years
Have been diagnosed by a specialist with one of the six chronic medical conditions described.
Special Risk Groups
1. Paediatric Rheumatalogical Disease
2. Inflammatory Bowel Disease
3. Acute Lymphoblastic Leukaemia
4. Solid Organ Transplant Recipients (kidney and liver)
5. Chronic Renal Disease
6. Bone Marrow Transsplant

Exclusion Criteria

Previous immunisation with HPV vaccine
Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[One month post third HPV vaccination]

Secondary Outcome Measures

Name	Time	Method
Describe the safety of the HPV vaccine in the six study groups using self reports and liason with treating sub specialist team.[One month post third HPV vaccination]