Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10963482 | Vaccine | 2015 | 8 Pages |
Abstract
Phase III lots can be produced in a consistent manner with predictable immune response and acceptable safety profile similar to previously characterised phase II lots. The phase III lots may be considered as not clinically different as statistical equivalence was shown for serotypes 1, 3 and 4 across the phase III lots. For serotype 2, although equivalence was not shown between two lots, the GMTs observed in the phase III lots were consistently higher than those for the phase II lot. As such, in our view, biological equivalence for all serotypes was demonstrated.
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Authors
Joseph Torresi, Leon G. Heron, Ming Qiao, Joanne Marjason, Laurent Chambonneau, Alain Bouckenooghe, Mark Boaz, Diane van der Vliet, Derek Wallace, Yanee Hutagalung, Michael D. Nissen, Peter C. Richmond,