A Study to Assess the Acceptability and Usability of a New Device for Intradermal Vaccination
NCT ID: NCT01963338
Last Updated: 2016-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2012-04-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Intradermal group
These group participants received two intradermal injections with the newly developed device, one in the forearm and one in the upper arm (deltoid region).
Intradermal injection in the forearm (0,1cc NaCl 0,9%)
This injection is conducted by the newly developed device.
Intradermal injection in the upper arm (0,1cc NaCl 0,9%)
This injection is conducted by the newly developed device in the upper arm (deltoid region).
Intramuscular group
These group participants received one intramuscular injection in the upper arm(deltoid region) using needle and syringe and one intradermal injection in the forearm using the newly developed device.
Intradermal injection in the forearm (0,1cc NaCl 0,9%)
This injection is conducted by the newly developed device.
Intramuscular injection in the upper arm (0,5cc NaCl 0,9%)
This injection is conducted by needle and syringe in the upper arm (deltoid region).
Interventions
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Intradermal injection in the forearm (0,1cc NaCl 0,9%)
This injection is conducted by the newly developed device.
Intradermal injection in the upper arm (0,1cc NaCl 0,9%)
This injection is conducted by the newly developed device in the upper arm (deltoid region).
Intramuscular injection in the upper arm (0,5cc NaCl 0,9%)
This injection is conducted by needle and syringe in the upper arm (deltoid region).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pregnant women
18 Years
65 Years
ALL
Yes
Sponsors
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Pierre Van Damme
OTHER
Responsible Party
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Pierre Van Damme
Professor
Principal Investigators
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Pierre Van Damme, Prof.
Role: STUDY_DIRECTOR
Universiteit Antwerpen
Locations
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University of Antwerp
Wilrijk, Antwerp, Belgium
Countries
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References
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Van Mulder TJ, Verwulgen S, Beyers KC, Scheelen L, Elseviers MM, Van Damme P, Vankerckhoven V. Assessment of acceptability and usability of new delivery prototype device for intradermal vaccination in healthy subjects. Hum Vaccin Immunother. 2014;10(12):3746-53. doi: 10.4161/21645515.2014.979655.
Other Identifiers
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cev2012-vaxid
Identifier Type: -
Identifier Source: org_study_id
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