A Phase IV, open label, single arm trial to assess the safety and immunogenicity of BIMERVAX® XFG.1.1 against SARS-CoV-2 Omicron XFG.1.1 variant.

COVID-19

Number, percentage, and characteristics of solicited local reactions and systemic events through Day 7 after vaccination., Number, percentage, and characteristics of unsolicited adverse events (AEs) through the end of the study., Number and percentage of serious adverse events (SAEs) through the end of the study., Number and percentage of adverse events of special interest (AESIs) through the end of the study., Number and percentage of related medically attended adverse events (MAAEs) through the end of the study., Neutralisation titres against Omicron XFG.1.1 variant, measured as inhibitory dilution 50 (ID50) by pseudovirion-based neutralisation assay (PBNA) and reported as reciprocal dilution for each individual sample and geometric mean titre (GMT), at Baseline and at Day 14., Geometric mean fold rise (GMFR) in neutralising antibody titres against Omicron XFG.1.1 variant from Baseline to Day 14.

Binding antibody titres measured by an electrochemiluminescence immunoassay (ECLIA) for each individual sample and GMT at Baseline and at Day 14., Percentage of participants experiencing an increase of ≥ 2-fold in binding antibody titres against SARS-CoV-2 measured by ECLIA from Baseline to Day 14.

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