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临床试验/ACTRN12609000050257
ACTRN12609000050257已完成未知

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 个研究点目标入组 19 人开始时间: 2009年1月22日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
19

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
2 Months 至 60 Years(—)
性别
All

入选标准

  • 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.

排除标准

  • 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

研究者

发起方
Women's and Children's Health Network

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