Condition: COVID 19 · Influenza · Rheumatoid Arthritis (RA) · Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC). The main questions it aims to answer are: 1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later? 2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals? Researchers will compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month afte…
This description comes directly from the study's public registry record.
Ruth Sapir-Pichhadze, B.Med.Sc, MD, MSc, PhD, FRCPC · 5149341934 · ruth.sapir-pichhadze.med@ssss.gouv.qc.ca
Always discuss trial participation with your own doctor first.
| Maisonneuve -Rosemont Installation | Montreal, Quebec, Canada | Recruiting |
| Centre hospitalier de l'Université de Montréal (CHUM) | Montreal, Quebec, Canada | Recruiting |
| Research Institute of McGill University Health Centre | Montreal, Quebec, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06599658