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

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.

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.