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

Pain Clinical Trial

Official title:

A Randomized Controlled Study to Assess the Acceptability and Usability of New Delivery Device for Intradermal Vaccination in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963338
• Other study ID #: cev2012-vaxid
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: March 15, 2016
• Start date: April 2012
• Est. completion date: May 2012

Study information

• Verified date: March 2016
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy adults

Exclusion Criteria:

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

• pregnant women

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain
• Vaccination Adverse Event

Intervention

Device:
• 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).

Drug:
• 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).

Locations

Country	Name	City	State
Belgium	University of Antwerp	Wilrijk	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Van Damme

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability (e.g. pain) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle	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.	1 day (directly after the injections)	No
Primary	Adverse events after an injection with an intradermal delivery device and/or intramuscular injection with syringe and needle	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.	during 5 days after the injections	No
Secondary	Usability (e.g. handling) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle	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.	Within one day after administering the injections	No