Trial NCT04588480
Publication Haranaka M, Nat. Commun., 2021
Primary outcome on the report: 1) local reactions or 2) systemic events for 7 days after each dose; 3) adverse events from dose 1 through 1 month after dose 2; 4) serious AEs (SAEs) collected from dose 1 through 12 months after dose 2 (reported to 1 month after dose 2 in this report); 5) hematology and clinical chemistry laboratory parameters up to 7 days after dose 2; 6) geometric mean titers (GMTs) of SARS-CoV-2 neutralization 1 month after dose 2; 7) geometric mean fold rises (GMFRs) of neutralizing titers from baseline to 1 month after dose 2.

Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.

Bias Author's judgement Support for judgement
Randomization
Low 		Quote: “interactive web-based response system”
Comment: Allocation sequence random.
Allocation sequence concealed.
Deviations from intervention
Low 		Quote: "Participants, investigators and other study staff were blinded; staff who dispensed/administered study medication were unblinded"
Comment: Blinded study (participants and personnel/carers).
ITT or available case analyses.
As we are assessing the effect of assignment to intervention, the analysis method performed on these outcomes was considered appropriate.
Risk assessed to be low for the outcomes: Mortality. Neutralizing antibody GMT. Adverse events. Withdrawals due to adverse events. Serious adverse events.
Missing outcome data
Low 		Comment: 160 participants randomized; 160 participants analyzed for safety; 157 participants analyzed for immunogenicicty.
Data available for all or nearly all participants randomized.
Risk assessed to be low for the outcomes: Mortality. Neutralizing antibody GMT. Adverse events. Withdrawals due to adverse events. Serious adverse events.
Measurement of the outcome
Low 		Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Blinded study (outcome assessor).
Risk assessed to be low for the outcomes: Mortality. Neutralizing antibody GMT. Adverse events. Withdrawals due to adverse events. Serious adverse events.
Selection of the reported results
Low 		Comment: The protocol, statistical analysis plan, and trial registry were available.
Outcome pre-specified.
Results were not selected from multiple outcome measurements or analyses of the data.
Trial analyzed as pre-specified.
Risk assessed to be low for the outcomes: Mortality. Neutralizing antibody GMT. Adverse events. Withdrawals due to adverse events. Serious adverse events.
Overall risk of bias
Low