PainNCT01963338
A Study to Assess the Acceptability and Usability of a New Device for Intradermal Vaccination
A study testing Intradermal injection in the forearm (0,1cc NaCl 0,9%), Intradermal injection in the upper arm (0,1cc NaCl 0,9%) and Intramuscular injection in the upper arm (0,5cc NaCl 0,9%) in people with Pain and Vaccination Adverse Event, run by Pierre Van Damme at 1 site in Belgium.
Trial summary
The aim of this study was to assess the acceptability and usability of a newly developed intradermal device in healthy adults Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Vaccination Adverse Event
- What is being tested?
- Intradermal injection in the forearm (0,1cc NaCl 0,9%), Intradermal injection in the upper arm (0,1cc NaCl 0,9%) and Intramuscular injection in the upper arm (0,5cc NaCl 0,9%)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2012to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults
Who cannot join
- people who have regular experience with needle injections, e.g. diabetic patients
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study to Assess the Acceptability and Usability of New Delivery Device for Intradermal Vaccination in Healthy Volunteers
The aim of this study was to assess the acceptability and usability of a newly developed intradermal device in healthy adults
- Conditions
- Pain, Vaccination Adverse Event
- Being tested
- Intradermal injection in the forearm (0,1cc NaCl 0,9%), Intradermal injection in the upper arm (0,1cc NaCl 0,9%), Intramuscular injection in the upper arm (0,5cc NaCl 0,9%)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal injection in the forearm (0,1cc NaCl 0,9%)Device
This injection is conducted by the newly developed device.
Intradermal injection in the upper arm (0,1cc NaCl 0,9%)Device
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%)Drug
This injection is conducted by needle and syringe in the upper arm (deltoid region).
| Study group | Role | What they receive |
|---|---|---|
| Intradermal group | Experimental | These group participants received two intradermal injections with the newly developed device, one in the forearm and one in the upper arm (deltoid region). Receives: 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 | 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. Receives: Device: Intradermal injection in the forearm (0,1cc NaCl 0,9%); Drug: Intramuscular injection in the upper arm (0,5cc NaCl 0,9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day (directly after the injections)
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.
Measured: during 5 days after the injections
Secondary outcomes (1)
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.
Measured: Within one day after administering the injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startApr 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Van Damme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierre Van Damme, Universiteit Antwerpen
- Investigators
- Pierre Van Damme, Prof., Study director, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963338
- Sponsor's protocol ID
- cev2012-vaxid
- Status last verified
- Mar 2016
- First submitted
- 7 Oct 2013
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25531808
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Assess the Acceptability and Usability of New Delivery Device for Intradermal Vaccination in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01963338
- Acronym / sponsor ID
- cev2012-vaxid
- Conditions
- Pain, Vaccination Adverse Event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Pierre Van DammeUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to assess the acceptability and usability of a newly developed intradermal device in healthy adults
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradermal group | Experimental | Device: Intradermal injection in the forearm (0,1cc NaCl 0,9%), Device: 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 | Experimental | Device: Intradermal injection in the forearm (0,1cc NaCl 0,9%), Drug: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults
Key exclusion criteria (2 listed)
- people who have regular experience with needle injections, e.g. diabetic patients
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal injection in the forearm (0,1cc NaCl 0,9%)This injection is conducted by the newly developed device. | Device | Intradermal group, Intramuscular group |
| 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). | Device | Intradermal group |
| 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). | Drug | Intramuscular group |
Primary outcome
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.
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Derived from this study: PubMed 25531808Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Van Damme, Prof. study director
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradermal injection in the forearm (0,1cc NaCl 0,9%), Intradermal injection in the upper arm (0,1cc NaCl 0,9%) and Intramuscular injection in the upper arm (0,5cc NaCl 0,9%) in people with Pain and Vaccination Adverse Event, run by Pierre Van Damme at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.