Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000050257
Ethics application status
Approved
Date submitted
18/11/2008
Date registered
22/01/2009
Date last updated
16/09/2021
Date data sharing statement initially provided
16/09/2021
Date results provided
16/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Descriptive study using ultrasound to assess the appropriate needle angle for intramuscular vaccine administration to ensure muscle penetration in adults, adolescents, children, toddlers and infants.
Scientific title
Descriptive study using ultrasound to assess the appropriate needle angle for intramuscular vaccine administration to ensure muscle penetration in adults, adolescents, children, toddlers and infants.
Universal Trial Number (UTN)
Trial acronym
DEVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vaccine preventable diseases 3997 0
Condition category
Condition code
Public Health 4196 4196 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two immunisations will be given appromximately 1-6 months apart (depending on cohort) whilst an ultrasound is performed over the area of injection. The first immunisation administrered with the angle of needle administration at 60 or 90 degrees. The second vaccination will be administered at the alternative angle under ultrasound examination. The ultrasound procedure will aim to view the tissues surrounding the injection site to visualise the entry of the needle and where the vaccinate is deposited.
Intervention code [1] 3721 0
Prevention
Comparator / control treatment
immunisation with angle of needle at 90 degrees
Control group
Active

Outcomes
Primary outcome [1] 5092 0
To describe the deposition of vaccinate during vaccine administration for needle administration at a 60 degree and 90 degree angle to the arm or thigh.
Timepoint [1] 5092 0
For adult and toddler cohorts - at vaccination occuring at randomisation and again 6 months later. For adolescent and children cohorts, at vaccinations occuring 1 and 6 months post randomisation. For infants, at vaccinations which occur at 4 and 6 months of age
Secondary outcome [1] 8551 0
To compare safety of vaccine administration at 60 or 90 angle. This will be measured using a seven day diary card which will record any local redness, swelling or pain that occurs following immunisation.
Timepoint [1] 8551 0
For adult and toddler cohorts - at vaccination occuring at randomisation and again 6 months later. For adolescent and children cohorts, at vaccinations occuring 1 and 6 months post randomisation. For infants, at vaccinations which occur at 4 and 6 months of age

Eligibility
Key inclusion criteria
1. Male or female subject in the age categories defined below:
· Adult : A male or female aged between and including 18 to 60 years of age.
· Adolescents : A male or female aged between and including 12 to 15 years of age
· Children: A male or female aged between and including 4 to 11 years of age
· Toddlers: A male of female aged between and including 1 to 3 years of age
· Infants: A male or female aged between and including 2 to 6 months of age
2. Written informed consent obtained from the participant.
3. Eligible to receive an intramuscular vaccination in the deltoid or anterior thigh of a licensed vaccine
4. Free of serious health problems as established by medical history ( and history directed examination only) before entering the study.
Minimum age
2 Months
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Contraindications to vaccine administration according to recommendations in the 9th edition of the Australian Immunisation Handbook including history of allergy to any component of the vaccine (including yeast).

2. Previous vaccination with the licensed vaccine offered
· Adults: previous Hepatitis A vaccine
· Adolescents/children: previous hepatitis A and hepatitis B vaccine
· Toddlers: previous Hepatitis A vaccine
· Infants: routine 4 and 6 month immunisations

3. Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs during a period starting from 2 weeks prior to enrolment.

4. History of allergy to aquasonic contact gel which will be used in the ultrasound examination (this gel is routinely used for all ultrasound examinations in the WCH radiology department).

5. Previous infection with Hepatitis A (VAQTA, Twinrix, Haxrix) or Hepatitis B (Twinrix)

6. No bleeding disorder or condition associated with a prolonged bleeding time that would contraindicate intramuscular injection including use of any anti-coagulants

7. Not pregnant or breast feeding at time of enrolment in the study and for the duration of the study

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)
Subjects will be randomised following consent to the study to either administration at a 60° angle or 90° angle. The second vaccination will be administered at the alternative angle under ultrasound examination. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation list will be available to randomise subjects in each group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
This is a descriptive study using ultrasound to assess the appropriate angle of administration for intramuscular vaccinations. License vaccines will be administered and site of administration will be consistent with recommendations in the Australian Immunisation Handbook.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
3/12/2008
Date of last participant enrolment
Anticipated
Actual
29/11/2010
Date of last data collection
Anticipated
Actual
18/08/2011
Sample size
Target
18
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 4185 0
Self funded/Unfunded
Name [1] 4185 0
Country [1] 4185 0
Primary sponsor type
Hospital
Name
Women's and Children's Health Network
Address
72 King William Road
North Adelaide, SA 5006
Country
Australia
Secondary sponsor category [1] 3760 0
Individual
Name [1] 3760 0
Dr Helen Marshall
Address [1] 3760 0
Discipline of Paediatrics Women's and Children's Hospital 72 King William Road North Adelaide SA 5006
Country [1] 3760 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6240 0
Children, Youth and Women's Health Service Research Ethics Committee
Ethics committee address [1] 6240 0
Ethics committee country [1] 6240 0
Australia
Date submitted for ethics approval [1] 6240 0
18/07/2008
Approval date [1] 6240 0
15/10/2008
Ethics approval number [1] 6240 0
2093/8/2011

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

Contacts
Principal investigator
Name 29145 0
Prof Helen Marshall
Address 29145 0
Women's and Children's Hospital 72 King William Road North Adelaide, SA 5006
Country 29145 0
Australia
Phone 29145 0
+6181618115
Fax 29145 0
Email 29145 0
[email protected]
Contact person for public queries
Name 12302 0
Dr Helen Marshall
Address 12302 0
Discipline of Paediatrics Women's and Children's Hospital 72 King William Road North Adelaide, SA 5006
Country 12302 0
Australia
Phone 12302 0
(08) 8161 8115
Fax 12302 0
(08) 8161 7031
Email 12302 0
[email protected]
Contact person for scientific queries
Name 3230 0
Dr Helen Marshall
Address 3230 0
Discipline of Paediatrics Women's and Children's Hospital 72 King William Road North Adelaide, SA 5006
Country 3230 0
Australia
Phone 3230 0
(08) 8161 8115
Fax 3230 0
(08) 8161 7031
Email 3230 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• requests for data will be reviewed by investigators and approved by WCHN HREC prior to release

Conditions for requesting access:
• -

What individual participant data might be shared?
• Deidentified participant data

What types of analyses could be done with individual participant data?
• analyses relevant to the study objectives

When can requests for individual participant data be made (start and end dates)?
From:
30 Jul 2021-30 Jul 2022

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• email request to [email protected] or [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13226Study protocol  [email protected]
13227Ethical approval  [email protected]



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.