- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01963338
A Study to Assess the Acceptability and Usability of a New Device for Intradermal Vaccination
A Randomized Controlled Study to Assess the Acceptability and Usability of New Delivery Device for Intradermal Vaccination in Healthy Volunteers
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Antwerp
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Wilrijk, Antwerp, Belgium, 2650
- University of Antwerp
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy adults
Exclusion Criteria:
- people who have regular experience with needle injections, e.g. diabetic patients
- pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
This injection is conducted by the newly developed device.
This injection is conducted by the newly developed device in the upper arm (deltoid region).
|
Experimental: 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.
|
This injection is conducted by the newly developed device.
This injection is conducted by needle and syringe in the upper arm (deltoid region).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability (e.g. pain) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle
Time Frame: 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.
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1 day (directly after the injections)
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Adverse events after an injection with an intradermal delivery device and/or intramuscular injection with syringe and needle
Time Frame: during 5 days after the injections
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability (e.g. handling) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle
Time Frame: Within one day after administering the injections
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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
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pierre Van Damme, Prof., Universiteit Antwerpen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- cev2012-vaxid
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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