How can I define a bio-equivalence margin in a vaccine trial?

20 June 2014 1 5K Report

If GMT ratio of two lots of vaccine are not 1... 2 times higher in one lot.

it depends which vaccine you are testing and whether there are WHO or other institutional recommendations for that vaccine. Usually the non inferiority with 10% margin has to be evaluated for new vaccines as compared to licensed ones (i.e. D,T, pertussis, Hep B , Hib). The endpoint is the proprotion of responders/seroconversion not the GMTs/GMCs

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