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.

Not Applicable

Completed

• Conditions: vaccine preventable diseases; Public Health - Health service research

• Registration Number: ACTRN12609000050257
• Lead Sponsor: Women's and Children's Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-22
• Study Completion: 2011-08-18
• Last Update Posted: 20 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[For adult and toddler cohorts - at vaccination occuring at randomisation and again 6 months later.<br>For adolescent and children cohorts, at vaccinations occuring 1 and 6 months post randomisation.<br>For infants, at vaccinations which occur at 4 and 6 months of age]

Secondary Outcome Measures

Name	Time	Method
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.[For adult and toddler cohorts - at vaccination occuring at randomisation and again 6 months later.<br>For adolescent and children cohorts, at vaccinations occuring 1 and 6 months post randomisation.<br>For infants, at vaccinations which occur at 4 and 6 months of age]