Figures & data
Table 1. Lot-to-lot-consistency among investigational vaccine lots, non-inferiority for pooled investigational vaccine vs. comparator and post-Dose 3 GMT of pooled investigational vaccine vs. comparator as per per-protocol analysis set in cohort 2.
Table 2. Seroprotection/seroresponse rate & Geometric Mean Concentrations of cohort 1.
Figure 1. Percentage of subjects in cohort 2 demonstrating a 4 Fold or more rise of anti-PT and anti-FHA antibody titers (Lot A, B and C refer to investigational vaccine).
Figure 2. RCDC (Reverse Cumulative Distribution Curves) for all investigational vs. comparator Pre-Primary and Post-Dose 3 in cohort 2 for Anti HBS antibody response.
Table 3. Incidence of solicited adverse reactions in cohort 2 as observed over 28 d of follow up period after each dose.
Table 4. Details of SAEs observed in cohort 2.
Table 5. Kit/Lab developed Assay and the cut-off values of seroprotection/seroresponse for different antibodies.
Figure 3. RCDC (Reverse Cumulative Distribution Curves) for all investigational vs. comparator Pre-Primary and Post-Dose 3 in cohort 2 for whole cell pertussis antibody response.
Figure 4. Cohort 2 Subject Disposition Flow Chart.
