A Study to Assess the Acceptability and Usability of a New Device for Intradermal Vaccination

Pierre Van Damme

Status: Completed

Conditions: Vaccination Adverse Event; Pain

Treatments: Drug: Intramuscular injection in the upper arm (0,5cc NaCl 0,9%); Device: Intradermal injection in the upper arm (0,1cc NaCl 0,9%); Device: Intradermal injection in the forearm (0,1cc NaCl 0,9%)

Study type: Interventional

Funder types: Other

Identifiers

NCT01963338

cev2012-vaxid

Details and patient eligibility

About

The aim of this study was to assess the acceptability and usability of a newly developed intradermal device in healthy adults

Enrollment: 102 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy adults

Exclusion criteria

• people who have regular experience with needle injections, e.g. diabetic patients
• pregnant women

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Intradermal group

Experimental group

Description:

These group participants received two intradermal injections with the newly developed device, one in the forearm and one in the upper arm (deltoid region).

Treatment:

Device: Intradermal injection in the forearm (0,1cc NaCl 0,9%)

Device: Intradermal injection in the upper arm (0,1cc NaCl 0,9%)

Intramuscular group

Experimental group

Description:

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.

Treatment:

Device: Intradermal injection in the forearm (0,1cc NaCl 0,9%)

Drug: Intramuscular injection in the upper arm (0,5cc NaCl 0,9%)