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Protecting Young Special Risk Females From Cervical Cancer Through Human Papilloma Virus (HPV) Vaccination

NCT00964210 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2011-04-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Licensed quadrivalent HPV vaccine, Gardasil

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.

Sponsors & Collaborators

  • Brockhoff Foundation Australia

    collaborator UNKNOWN

  • Shepherd Foundation Australia

    collaborator UNKNOWN

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Jim Buttery · NHMRC CCRE in Childhood and Adolescent Immunisation

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
26 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-12-31
Completion
2011-04-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00964210 on ClinicalTrials.gov