Fig. 2: Study flow chart showing the disposition of participants throughout the various phases of the study. | Nature Communications

Fig. 2: Study flow chart showing the disposition of participants throughout the various phases of the study.

From: Safety, immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine: pooled phase 1, 2, 3a and 3b randomized, controlled trials

Fig. 2

Numbers and percentages are based on those randomized; participants could be excluded from the analysis sets for more than one reason. Analysis sets: ITT, Intent-to-treat; mITT, modified Intent-to-treat; PP, Per protocol set; RAS, Reactogenicity analysis set; SAS, Safety analysis set; IAS, immunogenicity analysis set. In Phase 1/2/3a 1 participant randomized to ARCT-154 received Placebo as Dose 1 giving 748 receiving ARCT-154 and 253 receiving Placebo as Dose 1. Phase 3b: 7 participants randomized to Placebo did not receive Dose 1 giving 8041 in the SAS Placebo group; two participants who received ARCT-154 as Dose 1 but placebo as Dose 2 were removed from the ARCT-154 Dose 2 SAS arm giving 7867, and 6 participants randomized to Placebo received incorrect investigational product and were removed from the Placebo Dose 2 SAS arm giving 7822.

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