Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01896986




Registration number
NCT01896986
Ethics application status
Date submitted
25/06/2013
Date registered
11/07/2013
Date last updated
15/06/2017

Titles & IDs
Public title
HPV Vaccination in Special Risk Groups: 5 Year Follow-up
Scientific title
HPV Immunisation Protecting Special Risk Group Patients From Cervical Cancer: 5 Year Follow-up Post-vaccination
Secondary ID [1] 0 0
HPV girls 5year followup
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PRD (Paediatric Rheumatological Disease) 0 0
IBD (Inflammatory Bowel Disease) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
PRD patrients - Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)
Subgroups:
receiving immunosuppressant therapy
not on immunosuppressant therapy

IBD patients - Children/adolescent females 12-26 years diagnosed with IBD.
Subgroups:
3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Immunogenicity to HPV Vaccine Gardasil
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
- Females who participated in the initial HPV vaccine immunogenicity study in 2007.
Minimum age
12 Years
Maximum age
26 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to provide informed consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Childrens Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2106 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash Medical Centre
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
In 2007-2009 the investigators conducted a study to determine the immunogenicity response to
HPV vaccine in special risk patients known to be at increased risk of abnormal cervical
cytology. The serological response to the vaccine was measured 1 month post the third and
final dose (n=70) finding a robust response overall.

The aim of this follow-on study is to provide data on the long-term protection offered by the
HPV vaccination. The persistence of antibody 5 years post immunisation is unknown and the
impact on cervical cytology abnormalities in these special risk groups is important.

The study results will help inform national immunisation program recommendations re- booster
HPV vaccine doses.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01896986
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nigel Crawford, PhDMPHMBBS
Address 0 0
Royal Childrens Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01896986