Описание
Welcome to the Noro202 Study:
The purpose of this study is to assess the immune response of the Bivalent GI.1/GII.4 vaccine against Norovirus in healthy adults, as well as how safe the vaccine is.
New (investigational) medications, drugs and devices must be approved for use by the United States Food and Drug Administration (FDA).
The Bivalent GI.1/GII.4 vaccine is an experimental vaccine. This means that it is not an approved vaccine to prevent healthy adults from acquiring Norovirus in the United States or in any other country.
This research is being sponsored and conducted by Vaxart Inc.
Subject Journey
A subject who is identified as eligible for this study during screening will be invited to download the Noro202 Study App via e-mail.
Upon download, the participants create an account and is contacted by a study team member to complete the Informed Consent process. A series of screens explains the parameters of the study, including:
o Privacy Policy
o Data Gathering & Usage
o Study Tasks & Surveys
o Time Commitment
o Option to Withdraw
Subjects will connect with a member of the study team to ask questions and obtain a comprehensive understanding of the study prior to signing the informed consent form.
Intervention Period: Daily Tasks
Subjects will contribute data to the study by completing questionnaires and data uploads over a baseline period and 8 day active trial period. Subjects can interact with the study team via secure chat as needed.