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

Not Applicable

Completed

• Conditions: Pain; Vaccination Adverse Event
• Interventions: Device: Intradermal injection in the forearm (0,1cc NaCl 0,9%); Device: Intradermal injection in the upper arm (0,1cc NaCl 0,9%); Drug: Intramuscular injection in the upper arm (0,5cc NaCl 0,9%)

• Registration Number: NCT01963338
• Lead Sponsor: Pierre Van Damme

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-16
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• healthy adults

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intradermal group	Intradermal injection in the forearm (0,1cc NaCl 0,9%)	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 group	Intradermal injection in the upper arm (0,1cc NaCl 0,9%)	These group participants received two intradermal injections with the newly developed device, one in the forearm and one in the upper arm (deltoid region).
Intramuscular group	Intramuscular injection in the upper arm (0,5cc NaCl 0,9%)	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.
Intramuscular group	Intradermal injection in the forearm (0,1cc NaCl 0,9%)	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.

Primary Outcome Measures

Name	Time	Method
Adverse events after an injection with an intradermal delivery device and/or intramuscular injection with syringe and needle	during 5 days after the injections	Volunteers were asked to fill a daily electronic diary for 5 days after the injections. The diary surveyed the presence of local reactions (pain at injection site, redness, swelling, ecchymosis and hardening) and systemic adverse events (headache, malaise, chills, myalgia, arthralgia, weakness/fatigue and temperature). In case of local reactions, participants were asked to measure the size of the reaction (in mm). For this purpose, a transparent ruler was provided to the participants at the study day.
Acceptability (e.g. pain) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle	1 day (directly after the injections)	Each of the volunteers was asked to complete two questionnaires: first questionnaire surveyed demographic parameters, including gender, age, health care related job or education, number of vaccinations and blood samples taken during the last 5 years, second questionnaire surveyed the experience of ID and/or IM injection, such as anxiety, pain during injection and duration of injection. Also the perception of the participant towards injections into the forearm, which could be perceived as an unnatural site for vaccination, and perception towards the need to undress for IM vaccination, i.e. preparing the upper arm for injection, was asked. The Visual Analogue Scale (1=no agreement; 10=full agreement) was used to score the statements.

Secondary Outcome Measures

Name	Time	Method
Usability (e.g. handling) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle	Within one day after administering the injections	At the end of a study day, the nurses performing the injections received a questionnaire that assessed the usability of VAX-ID. The nurses were requested to rate the attractiveness, handling, solidity, safety and ease of use. Some questions assessed their experience relating to painful(ness), speed and injection sites. Also their thoughts on the usability by non-medical staff (with or without any manual) and on self-administration by patients were inquired.; The Visual Analogue Scale (1=no agreement; 10=full agreement) was used to score the statements. An expert panel was organized in order to gather additional comments, remarks and proposed improvements on the use of the VAX-ID.

Trial Locations

Locations (1)

University of Antwerp; 🇧🇪 Wilrijk, Antwerp, Belgium