Statistical Analysis of Influenza Vaccine Lot Consistency Studies

This paper presents an integrated statistical approach to the analysis of influenza vaccine lot consistency studies in which three lots are compared. The approach ensures that the overall Type I error rate (i.e., the probability of wrongly concluding that the lots are similar) is controlled. It is argued that the optimum efficacy measure is the geometric mean titer. The approach is demonstrated using data from a randomized, double-blind lot consistency study in which three consecutive production lots of Solvay Pharmaceutical' new, virosomal subunit influenza vaccine Invivac ® were compared.