Table 4.
Maternal Efficacy Endpoint Outcome | IIV (n = 88) |
Placebo (n = 78) |
VE (95% CI) | P Value |
---|---|---|---|---|
PCR-CI including B/Yamagata | 7 (8.0) | 16 (20.5) | 61.2 (10.7–83.2) | .019 |
PCR-CI excluding B/Yamagata | 7 (8.0) | 13 (16.7) | 52.3 (−135.6 to 79.9) | .085 |
Serologically diagnosed A/H1N1pdm09 | 12 (13.6) | 27 (34.6) | 60.6 (27.7–78.5) | .002 |
Serologically diagnosed A/H3N2 | 3 (3.4) | 11 (14.1) | 75.8 (16.5–93.0) | .022 |
Serologically diagnosed B/Victoria | 6 (6.8) | 9 (11.5) | 40.9 (−58.6 to 78.0) | .290 |
Serologically diagnosed infection for at least 1 strain | 15 (17.0) | 34 (43.6) | 60.9 (33.9–76.9) | <.001 |
Composite SDI or PCR-CI A/H1N1pdm09 | 17 (19.3) | 31 (39.7) | 51.4 (19.3–70.7) | .004 |
Composite SDI or PCR-CI A/H3N2 | 4 (4.5) | 13 (16.7) | 72.7 (19.8–90.7) | .019 |
Composite SDI or PCR-CI B/Victoria | 6 (6.8) | 9 (11.5) | 40.9 (−58.6 to 78.0) | .290 |
Overall composite SDI or PCR-CI (including B/Yamagata) | 20 (22.7) | 42 (53.8) | 57.8 (34.7–72.7) | <.001 |
Overall composite SDI or PCR-CI (excluding B/Yamagata) | 20 (22.7) | 40 (51.3) | 55.7 (31.1–71.5) | <.001 |
Abbreviations: CI, confidence interval; IIV, trivalent inactivated influenza vaccine; PCR-CI, polymerase chain reaction–confirmed influenza illness; SDI, serologically diagnosed influenza infection; VE, vaccine efficacy.