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: "Eligible participants were sequentially assigned a randomisation
number, according to a blocked randomisation list (block size 4) generated by an independent statistician using SAS software (version 9.4) Pre-existing adenovirus type-5 neutralising antibody is slightly higher in the experimental arm
Comment: Allocation sequence random /probably random. Allocation sequence concealed |
| Deviations from intervention |
Low |
Comment: Blinded 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. ITT analysis was performed on the outcomes. As we are assessing the effect of assignment to intervention, the analysis method performed on these safety outcomes, was considered appropriate. Risk assessed to be low for the outcomes: Local adverse events. Systemic adverse events. Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: [508] participants randomized; [508] participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes:Local adverse events. Systemic adverse events. 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: Local adverse events. Systemic adverse events. Adverse events. Serious adverse events. , |
| Selection of the reported results |
Low |
Comment: The registry was available (April 10, 2020)
Outcomes pre-specified. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Local adverse events. Systemic adverse events. Adverse events. Serious adverse events. |
| Overall risk of bias |
Low |