Sign Out
Clinical Trials: The safety and immunogenicity of this vaccine were evaluated in a phase III, randomized, double-blind and non-inferiority study designed with a positive control of imported similar vaccine. The blood samples were collected pre-immunization as well as on Day 30 and 35 post-immunization, respectively. The ELISA assay was used to detect the pneumococcal antibody concentrations of 23 serotypes. The percentages of subjects with 2-fold increase in the antibody concentrations of each serotype were compared to those obtained pre-immunization for both the PPSV23 group and the PNEUMOVAX 23 group. The overall percentage of subjects with 2-fold increase in the antibody concentrations of all 23 serotypes and the geometric mean antibody concentrations (GMCs) were also determined.
A total of 1660 subjects were enrolled in the phase III study, among which 1619 cases (97.53%) completed all study procedures, and 41 cases (2.47%) dropped out, resulting in 1619 cases (97.53%) included in the Full Analysis Set (FAS), and 1606 cases (96.75%) in the Per-Protocol Set (PPS). All subjects were involved in the safety analysis. FAS was determined as the primary analysis set, and the results obtained from FAS were basically consistent with those from PPS (Table 2 and Table 3). (See Tables 2 and 3.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
Continue with Google