None listed
Conditions
Brief summary
To determine characteristics of vaccination technique & individuals which are associated with severity of common adverse events following immunisation.
Interventions
Participants will be randomised to receive one of the three injection techniques below:
1. Fast without aspiration – Administration into the deltoid at 90 degrees. This involves a rapid plunge, no aspiration, & withdrawal of the needle following immunisation lasting less than 1 second.
2. Slow with aspiration – Administration into the deltoid at 90 degrees. This involves a slow plunge, aspiration, & slow withdrawal of the needle following immunisation over a period lasting 5-10 seconds and
3.
Participants will be randomised to receive one of the three injection techniques below: 1. Fast without aspiration – Administration into the deltoid at 90 degrees. This involves a rapid plunge, no aspiration, & withdrawal of the needle following immunisation lasting less than 1 second. 2. Slow with aspiration – Administration into the deltoid at 90 degrees. This involves a slow plunge, aspiration, & slow withdrawal of the needle following immunisation over a period lasting 5-10 seconds and 3. Slow without asperation - Administration into the deltoid at 90 degrees. This involves a slow plunge, no aspiration, & slow withdrawal of the needle following immunisation over a period lasting 5-10 seconds.
Sponsors
Uniservices and University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
14 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy girls and women aged between 14 and 26 years of age.
Exclusion criteria
Contraindication to receiving gardasil vaccine or unwell on the day of vaccination without a regualr telephone or who do not speak English
Outcome results
None listed