Trial NCT04683484
Publication Nguyen T, Lancet, 2022
Primary outcome on the report: Number and percentage of participants with solicited local and systemic adverse events occurred within 7 days after vaccination andlaboratory results (serum biochemistry and hematology) at days 0, 7, 28, 35 according to FDA toxicity scoring; anti-S IgG responses to Nanocovax evaluated by chemiluminescence immunoassay (CLIA)

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: “Computer randomization was done with full allocation concealment within the secure web platform used for the study electronic case report form (service provided by Medprove company).”
Comment: Allocation sequence random. Allocation sequence concealed.
Deviations from intervention
Low 		Quote: “Open-label”
Comment: Unblinded study (participants and personnel/carers)
Deviations from intended intervention arising because of the study context:
No participant cross-over.
Hence, deviations did not arise because of the trial context.
Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention.
Risk assessed to be low for the outcomes: Serious adverse events.
Missing outcome data
Low 		Comment: 60 participants randomized; 60 participants analyzed.
Data available for all participants randomized.
Risk assessed to be low for the outcomes: Serious adverse events.
Measurement of the outcome
Some concerns 		Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Unblinded study (outcome assessor).
The authors reported on withdrawals due to adverse events and serious adverse events that may contain both clinically- and laboratory-detected events, which can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic.
Risk assessed to be some concerns for the outcomes: Serious adverse events.
Selection of the reported results
Low 		Comment: The trial registry was available.
Outcomes were 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: Serious adverse events.
Overall risk of bias
Some concerns