Trial registration
MAY
The study protocol was approved by the Institutional Review Board on 26 May 2021, and enrollment in part A of the study was initiated on 28 May 2021, before the trial posting date of 14 June 2021 on the clintrials.gov registration website as we were emergently advancing COVID-19 booster vaccine candidates to combat the SARS-CoV-2 pandemic (the objective of this trial). Nonetheless, the trial was registered within 21 days after the first participant was enrolled, compliant per clinicaltrials.gov guidance (The trial is being conducted across 23 US sites, in accordance with the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Good Clinical Practice guidelines. The central Institutional Review Board (Advarra, Inc., 6100 Merriweather Drive, Columbia, MD 21044) approved the protocol and consent forms. All participants provided written informed consent. The study was funded by the sponsor, Moderna, Inc. and was involved in the study design as well as the collection, analysis and interpretation of the data.