The brunt of what you are asking is done, like you said by statistics and the likelihood the results were seen due to chance (lower is better, and generally less than 5% chance is accepted). Further, you could quantify your results (and then use statistics) by saying what percentage reduction in infection do we see –> this is how we might determine the efficacy of the drug, or what percent reduction in severity, and so on.
However, another major reason for these larger trials is to test for their safety, to find uncommon side effects, as smaller trials are sufficient to determine efficacy (or at least good enough efficacy for the vaccine to be worth it. What I mean by this is if in a trial of 40 people, you can’t tell if the vaccine is efficacious, it means it has a low efficacy and then it’s probably not worth it).
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