Table 3.
Strain (fHBP Variant) and Time Point | Bivalent rLP2086 + DTaP/IPV |
Saline + DTaP/IPV |
||
---|---|---|---|---|
na | hSBA GMT (95% CI)b,c | na | hSBA GMT (95% CI)b,c | |
PMB80 (A22) | ||||
Vaccination 2 | 154 | 35.5 (30.3–41.6) | 166 | 11.2 (10.0–12.5) |
Vaccination 3 | 158 | 63.4 (55.3–72.8) | 166 | 11.0 (9.9–12.3) |
PMB2001 (A56) | ||||
Vaccination 2 | 149 | 91.1 (78.0–106.5) | 151 | 8.3 (6.8–10.3) |
Vaccination 3 | 148 | 151.5 (131.5–174.6) | 152 | 8.5 (6.9–10.5) |
PMB2948 (B24) | ||||
Vaccination 2 | 153 | 15.9 (13.6–18.6) | 167 | 4.8 (4.4–5.2) |
Vaccination 3 | 157 | 28.3 (24.5–32.7) | 170 | 4.8 (4.4–5.2) |
PMB2707 (B44) | ||||
Vaccination 2 | 146 | 14.6 (11.6–18.4) | 159 | 4.7 (4.2–5.1) |
Vaccination 3 | 146 | 36.5 (28.9–46.2) | 159 | 4.7 (4.3–5.2) |
Abbreviations: CI, confidence interval; DTaP/IPV, diphtheria, tetanus, and acellular pertussis and inactivated poliovirus vaccine; GMT, geometric mean titer; hSBA, serum bactericidal assay using human complement.
an = number of participants with a valid and determinate hSBA titer result for the given strain. There were 637 participants in the bivalent rLP2086 immunogenicity population, including 307 participants in the bivalent rLP2086 + DTaP/IPV group and 330 participants in the saline + DTaP/IPV group.
bCIs are back transformations of CIs based on the Student t test distribution for the mean logarithm of the hSBA titers.
cSera from approximately 50% of the participants from each vaccination group were tested in hSBAs for strains A22 and B24, and sera from the remaining 50% of the participants were tested for strains A56 and B44.