ACTRN12609000050257
Completed
未知
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.
Women's and Children's Health Network0 sites19 target enrollmentJanuary 22, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Women's and Children's Health Network
- Enrollment
- 19
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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