Safety and immunogenicity of a high-dose quadrivalent influenza vaccine administered concomitantly with a third dose of the mRNA-1273 SARS-CoV-2 vaccine in adults aged ≥65 years: a phase 2, randomised, open-label study
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SciScore for 10.1101/2021.10.29.21265248: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All participants provided written informed consent.
Field Sample Permit: This work was carried out in collaboration with Moderna, Inc. and the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.Sex as a biological variable not detected. Randomization Procedures: Participants were randomised in a 1:1:1 ratio, using a permuted block method stratified by site and by age group (< 75 years and ≥ 75 years), to receive concomitant administration of QIV-HD and mRNA-1273 vaccine (Coad group), QIV-HD alone (QIV-HD group), or mRNA-1273 vaccine alone … SciScore for 10.1101/2021.10.29.21265248: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All participants provided written informed consent.
Field Sample Permit: This work was carried out in collaboration with Moderna, Inc. and the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.Sex as a biological variable not detected. Randomization Procedures: Participants were randomised in a 1:1:1 ratio, using a permuted block method stratified by site and by age group (< 75 years and ≥ 75 years), to receive concomitant administration of QIV-HD and mRNA-1273 vaccine (Coad group), QIV-HD alone (QIV-HD group), or mRNA-1273 vaccine alone (mRNA-1273 group). Blinding not detected. Power Analysis not detected. Cell Line Authentication Authentication: The SARS-CoV-2 Pre-Spike IgG enzyme-linked immunosorbent assay was a validated assay, performed by Nexelis (Laval, Quebec, Canada) as previously described. Table 2: Resources
Antibodies Sentences Resources To describe the SARS-CoV-2 binding antibody response, the following endpoints were reported for each treatment group: geometric mean concentration (GMCs) of anti-S binding IgG on D1 and D22, and D22/D1 ratios; ≥ two-fold-rise and ≥ four-fold-rise in anti-S binding IgG on D22. anti-S binding IgGsuggested: (Imported from the IEDB Cat# mAb 201, RRID:AB_2848089)D22suggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04969276 Recruiting Study of a Quadrivalent High-Dose Influenza Vaccine and a Mo… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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