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.

Category Primary study
Registry of TrialsANZCTR
Year 2009
INTERVENTION: 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. CONDITION: vaccine preventable diseases PRIMARY OUTCOME: 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. SECONDARY OUTCOME: 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. 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.
Epistemonikos ID: b7b4c879de71dbbb02213d83efb10ee112003cd8
First added on: Aug 25, 2024