Trial NCT04636697
Publication Gobeil P, medRxiv, 2021
Primary outcome on the report: Primary safety outcomes were the occurrence(s) of i) immediate AEs within 30 minutes after each vaccination; ii) solicited local and systemic AEs up to 7 days after each vaccination; iii) unsolicited AEs, serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and deaths up to 21 days after each vaccination; iv) normal and abnormal urine, haematological, and biochemical values. Primary immunogenicity outcomes were i) neutralizing antibody (NAb) titers measured using a pseudovirion neutralization assays and ii) interferon (IFN)-γ and IL-4 ELISpot responses at 21 days after each dose of vaccine.

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: "Randomization was managed by Syneos Health with Medicago oversight using Medidata Rave RTSM interactive randomization tool (2021.2.0, Medidata, USA)."
Comment: Allocation sequence random. Allocation sequence probably concealed.
Imbalances in baseline characteristics appear to be compatible with chance.
Deviations from intervention
* 		This outcome-specific domain was not assessed; Pending contact with authors.
No review-specific outcomes reported/extracted.
Missing outcome data
* 		This outcome-specific domain was not assessed; Pending contact with authors.
No review-specific outcomes reported/extracted.
Measurement of the outcome
* 		This outcome-specific domain was not assessed; Pending contact with authors.
No review-specific outcomes reported/extracted.
Selection of the reported results
* 		This outcome-specific domain was not assessed; Pending contact with authors.
No review-specific outcomes reported/extracted.
Overall risk of bias
*