None listed
Conditions
Brief summary
This is a descriptive study using ultrasound to assess the appropriate angle of administration for intramuscular vaccinations. The primary aim of this study is to use ultrasound assessment to accurately describe where the vaccine is delivered during vaccine administration for needle administration at a 60° and 90° angle to the arm or thigh. The study will also compare any reactions (such as redness, swelling, pain) for 7 days following immunisation when the vaccine is administered at either 60° or 90° angle.
Interventions
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 depos
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.
Sponsors
Women's and Children's Health Network
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Months to 60 Years
Healthy volunteers
Yes
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
Outcome results
None listed