Table 1 Comparison of Inclusion/Exclusion Criteria for the Per- Protocol (PP) and Modified Intention-to-Treat (MITT) Analyses
Criteria for Comparison | PP Analysis | MITT Analysis |
|---|---|---|
Infants Randomized but Not Vaccinateda | Excluded | Excluded |
Infants without Follow-up | Excludes infants where the end of follow up occurs before 14 days after dose 3 | Excludes infants where the end of follow up is the same day as the first vaccinationa |
Infants classified as not-evaluable (Infants are classified as not-evaluable if they have one or more episodes not-evaluable for rotavirus and no episodes positive for rotavirus) | Episodes were classified as not-evaluable if the stool specimen was positive for wild-type rotavirus prior to 14 days after dose 3, if there was incomplete clinical and/or laboratory results, or the stool specimen was collected outside the 14 day range after symptom onset | Episodes were classified as not-evaluable if the clinical and/or laboratory results were incomplete or the stool specimen was collected outside the 14 day range after symptom onset |
Infants with protocol violations | Excluded | Included |
Serotypes | Overall analysis was limited to RVGE due to G1-G4 serotypes | Overall analysis included all RVGE regardless of serotype |