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/study/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:

1. receiving immunosuppressant therapy
2. 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
Stopped early
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01896986