Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000395033
Ethics application status
Approved
Date submitted
5/05/2010
Date registered
17/05/2010
Date last updated
6/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Individual factors associated with vaccine reactogenicity - a randomised controlled trial in young women aged 14 - 26
Scientific title
Injection technique and individual characteristics associated with local reactogenicity to quadrivalent human papillomavirus vaccine in young women
Secondary ID [1] 251717 0
Nil
Universal Trial Number (UTN)
111-111-9806
Trial acronym
FAR Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
injection site reactions following vaccination 251896 0
Condition category
Condition code
Inflammatory and Immune System 252071 252071 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive one of the three injection techniques below:
1. Fast without aspiration – Administration into the deltoid at 90 degrees. This involves a rapid plunge, no aspiration, & withdrawal of the needle following immunisation lasting less than 1 second.
2. Slow with aspiration – Administration into the deltoid at 90 degrees. This involves a slow plunge, aspiration, & slow withdrawal of the needle following immunisation over a period lasting 5-10 seconds and
3. Slow without asperation - Administration into the deltoid at 90 degrees. This involves a slow plunge, no aspiration, & slow withdrawal of the needle following immunisation over a period lasting 5-10 seconds.
Intervention code [1] 241325 0
Other interventions
Intervention code [2] 256443 0
Prevention
Comparator / control treatment
The 3 different injection techniques will be compared.
Control group
Active

Outcomes
Primary outcome [1] 252965 0
Local injection site reaction: Pain
Assessed using participant held diary with pain scale 0 - 3
0= no pain
1= mild, still able to move arm normally
2=moderate, hurts to move arm normally or to touch
3=severe, unable to move arm
Timepoint [1] 252965 0
Each day followng injection for 7 days.
Primary outcome [2] 252966 0
Local injection site reaction: erythema
Assessed using participant held diary measured in mm using a measuring tool provided (clear acetate with circles of increasing diameter).
Timepoint [2] 252966 0
Each day followng injection for 7 days.
Primary outcome [3] 252967 0
Local injection site reaction: induration and swelling
Assessed using participant held diary measured in mm using a measuring tool provided (clear acetate with circles of increasing diameter).
Timepoint [3] 252967 0
Each day followng injection for 7 days.
Secondary outcome [1] 257703 0
Perceived pain on injection as measured by visual analogue pain scale
Timepoint [1] 257703 0
Measured immediatly following administration of vaccine.

Eligibility
Key inclusion criteria
Healthy girls and women aged between 14 and 26 years of age.
Minimum age
14 Years
Maximum age
26 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindication to receiving gardasil vaccine or unwell on the day of vaccination without a regualr telephone or who do not speak English

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to injection technique will be concealed at enrolment. There will be no attempt at conceament of the injection technique during the procedure. allocation will be in sealed opaque envelopes and revealed to the vaccinator at the time of vaccine administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment outside Australia
Country [1] 2151 0
New Zealand
State/province [1] 2151 0
Auckland

Funding & Sponsors
Funding source category [1] 243773 0
University
Name [1] 243773 0
Uniservices and University of Auckland
Country [1] 243773 0
New Zealand
Primary sponsor type
University
Name
Uniservices and University of Auckland
Address
School of Population Health
Tamaki Campus
261 Morrin rd
Glen Innes
Auckland 1072
Country
New Zealand
Secondary sponsor category [1] 237132 0
None
Name [1] 237132 0
Address [1] 237132 0
Country [1] 237132 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243903 0
Northern X Regional Ethics Committee
Ethics committee address [1] 243903 0
Ministry of health
650 Great South Rd
Penrose
Auckland 1051
Ethics committee country [1] 243903 0
New Zealand
Date submitted for ethics approval [1] 243903 0
Approval date [1] 243903 0
04/05/2009
Ethics approval number [1] 243903 0
NTX/09/02/001

Summary
Brief summary
To determine characteristics of vaccination technique & individuals which are associated with severity of common adverse events following immunisation.
Trial website
www.immune.org.nz/?t=997
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30318 0
Address 30318 0
Country 30318 0
Phone 30318 0
Fax 30318 0
Email 30318 0
Contact person for public queries
Name 13565 0
Helen Petousis-Harris
Address 13565 0
Immunisation Advisory Centre
Dept General Practice and Primary Health Care
School of Population Health, University of Auckland
Tamaki Campus
261 Morrin Rd, Glenn Innes
Auckland 1072
Country 13565 0
New Zealand
Phone 13565 0
64 09 9232078
Fax 13565 0
64 09 3737030
Email 13565 0
[email protected]
Contact person for scientific queries
Name 4493 0
Helen Petousis-Harris
Address 4493 0
Immunisation Advisory Centre
Dept General Practice and Primary Health Care
School of Population Health, University of Auckland
Tamaki Campus
261 Morrin Rd, Glenn Innes
Auckland 1072
Country 4493 0
New Zealand
Phone 4493 0
64 09 9232078
Fax 4493 0
64 09 3737030
Email 4493 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.