Immunogenicity and safety of a single booster dose of NVX-CoV2373 (TAK-019) in healthy Japanese adults who had previously received a primary series of COVID-19 mRNA vaccine: Primary analysis report of a phase 3 open-label trial.

"appendix a supplementary material the following are the supplementary data to this article: supplementary data 1 data availability the datasets including the redacted study protocol redacted statistical analysis plan and individual participant data supporting the results of the completed study will be made available after the publication of the final study results within 3 months from initial request to researchers who provide a methodologically sound proposal."

"Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Kenji Kuriyama reports a relationship with Takeda Pharmaceutical Company Ltd that includes: employment. Kyoko Murakami reports a relationship with Takeda Pharmaceutical Company Ltd that includes: employment and equity or stocks. Taisei Masuda reports a relationship with Takeda Pharmaceutical Company Ltd that includes: employment. Kenkichi Sugiura reports a relationship with Takeda Pharmaceutical Company Ltd that includes: employment. Sho Sakui reports a relationship with Takeda Pharmaceutical Company Ltd that includes: employment. Ron P. Schuring reports a relationship with Takeda Pharmaceuticals International AG that includes: employment. Mitsuhiro Mori reports a relationship with Takeda Pharmaceutical Company Ltd that includes: employment]."

"Funding This study was funded by Takeda Pharmaceutical Company Limited, Tokyo, Japan and the Ministry of Health, Labour and Welfare, Tokyo, Japan."

"This was a phase 3, single-arm, open-label trial conducted at two centres in Japan (ClinicalTrials.gov identifier NCT05299359). The study commenced on 15 April 2022 and is ongoing at the time of writing. The study was conducted in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines and the Declaration of Helsinki ethical principles. In accordance with guidance from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, the trial design was developed to assess non-inferiority of the geometric mean titre (GMT) ratio of titres of serum neutralizing antibodies (nAbs) against the SARS-CoV-2 ancestral strain in this study, compared with those observed after the second vaccination of participants in the TAK-019-1501 study (NCT04712110) . To ensure comparability between the two studies, the participant population, sample size, serum nAb assay method and measurement facility were matched. The study protocol and amendments were approved by the Institutional Review Board at each study centre. All participants provided written informed consent before enrolment. Participants from the TAK-019-1501 study had provided written informed consent for the secondary use of clinical data obtained from them."