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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02263703




Registration number
NCT02263703
Ethics application status
Date submitted
3/10/2014
Date registered
13/10/2014

Titles & IDs
Public title
Immunogenicity of HPV Vaccine in Immunosuppressed Children
Scientific title
Immunogenicity and Duration of Immunity in Immunosuppressed Children Vaccinated With Quadrivalent HPV Vaccine
Secondary ID [1] 0 0
2007/028
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autoimmune Disease 0 0
Juvenile Idiopathic Arthritis 0 0
Inflammatory Bowel Disease 0 0
Evidence of Liver Transplantation 0 0
Kidney Transplant Infection 0 0
Bone Marrow Transplant Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Quadrivalent HPV vaccine

Experimental: HPV vaccine - Quadrivalent HPV vaccine


Treatment: Other: Quadrivalent HPV vaccine
Three 0.5 mL doses will be given at time 0, 2 months after the 1st dose and then 6 months after the initial dose. For kidney transplant recipients the first dose will be at least 6 months post-transplant.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Immunogenicity
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Duration of immunity
Timepoint [1] 0 0
5 years

Eligibility
Key inclusion criteria
- Immunosuppressed patients with following diseases; Bone marrow transplant recipients, liver transplant patients, renal transplant, Children with inflammatory bowel disease, juvenile Idiopathic arthritis and autoimmune conditions.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* A platelet count of <50
* Immunoglobulin therapy within 3 months.
* Yeast allergy
* Any other known allergies to one of the vaccine component

Study design
Purpose of the study
Prevention
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
School of Public Health and Community Medicine - Sydney
Recruitment postcode(s) [1] 0 0
2052 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sydney Children's Hospitals Network
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Women's and Children's Hospital, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Raina MacIntyre
Address 0 0
The University of New South Wales
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We would like to share publication(s) that may arise from the study when applicable.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal MacIntyre CR, Shaw P, Mackie FE, Boros C, Marshall... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT02263703