Primary Day-28 Analysis of a Phase 2/3 Open-Label Study
The study, identified by the clinical trial number NCT05975060, was a collaborative effort between Novavax, Inc. and the investigators, focusing on the protocol, data analysis, interpretation, and preparation of the paper. It was conducted in accordance with the International Conference on Harmonization Good Clinical Practice Guideline and adhered to the principles of the Declaration of Helsinki, alongside all applicable national, state, and local laws and regulations. The ethical approval for the study was granted by Advarra, Inc. (Columbia, MD, USA), ensuring that all necessary patient/participant consent was obtained and archived appropriately. The study's integrity was maintained by ensuring that patient/participant/sample identifiers were not disclosed outside the research group, safeguarding participant confidentiality. The research reporting followed the EQUATOR Network research reporting checklist(s) and other pertinent materials, confirming the study's adherence to high standards of clinical trial reporting.