Clinical trial design
non-Pharma
An open label, non-randomized academic (non-Pharma sponsored) clinical trial was conducted in order to assess safety and immunological responses of concomitant vaccination with three currently licensed flavivirus vaccines. The trial was conducted at the Karolinska University Hospital, Stockholm, Sweden. An independent data monitoring process was setup by the Karolinska Trial Alliance (KTA) support organization (KTA Support) in order to review safety data and the progress of the study according to the clinical trial protocol. The monitoring process also included review of the trial’s conductance in accordance with principles of good clinical practice (ICH-GCP) [