PASSReviewer 1· 85% conf
Methods are sufficiently detailed, the trial is registered, outcomes appear consistently reported, limitations are discussed, conclusions are proportionate, and funding/COI are disclosed; no reporting checklist (e.g., CONSORT) is referenced.
Evidence
direct quote[Methods, Study oversight]
“ClinicalTrials.gov (https://ClinicalTrials.gov) number, NCT05048875 (https://clinicaltrials.gov/ct2/show/NCT05048875)”direct quote[Discussion, paragraph 5]
“Findings from those studies must be confirmed in larger safety and efficacy studies in the target population since CHIM studies do not reflect field conditions.”direct quote[Funding Statement]
“This study was funded in part by the Intramural Research Program of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) and Johnson & Johnson.”PASSReviewer 2· 85% conf
Methods are detailed, the trial is registered (NCT05048875), outcomes are reported including negatives, limitations are discussed, conclusions are proportional, and funding/COI are disclosed; only a reporting-guideline (CONSORT) reference is missing.
Evidence
direct quote[Methods, Study oversight]
“ClinicalTrials.gov (https://ClinicalTrials.gov) number, NCT05048875 (https://clinicaltrials.gov/ct2/show/NCT05048875)”direct quote[Funding Statement]
“This study was funded in part by the Intramural Research Program of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) and Johnson & Johnson.”PASSReviewer 3· 85% conf
Trial registration, methods, funding/COI, limitations, and proportional conclusions are all reported; only a CONSORT-style reporting-guideline reference is missing.
Evidence
direct quote[Methods, Study oversight]
“ClinicalTrials.gov (https://ClinicalTrials.gov) number, NCT05048875”direct quote[Discussion]
“Findings from those studies must be confirmed in larger safety and efficacy studies in the target population since CHIM studies do not reflect field conditions.”direct quote[Funding Statement]
“This study was funded in part by the Intramural Research Program of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) and Johnson & Johnson.”