The Internet-based study adds a new tool for collecting subjects that goes well beyond using introductory psychology students, phone and mail surveys, and the exhausting effort of soliciting subjects from the community.
"I think trying to read a broad spectrum of publications was highly valuable because we were soliciting subjects for improvisational scenes from the audience every night".
18, 19 In addition to soliciting subjects for the occurrence of symptoms that could be expected in response to a live DENV vaccine, we also collected all spontaneous reports of adverse events (unsolicited symptoms) for 31 days after each vaccination and SAEs throughout the study.
By soliciting feedback from subject matter experts, family leaders, and the lay public, we improved the likelihood that the questionnaire items will be understood and interpreted as intended.
Adverse experiences were solicited from subjects by general questioning at study visits and using a vaccine report card (VRC).
The most important endpoints for safety were injection site and general symptoms that we solicited from subjects by asking them to maintain a diary for 21 days after each vaccination.
To solicit selected subjects to participate in the NESCaV project, an official letter was sent by the investigators to explain the study objectives, relevance to public health policies, ways of participation, tests to be performed, and participant's rights.
