Table 3.
Efficacy of Trivalent Inactivated Influenza Vaccination of Human Immunodeficiency Virus–Uninfected Women up to 24 Weeks Postpartum
| Maternal Efficacy Endpoint Outcome | 2011 Cohort | 2012 Cohort | Overall Cohort | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IIV (n = 77) | Placebo (n = 82) | VE (95% CI) |
P Value | IIV (n = 84) |
Placebo (n = 78) |
VE (95% CI) |
P Value | IIV (n = 161) |
Placebo (n = 160) |
VE (95% CI) |
P Value | |
| PCR-CI including B/Yamagata | 1 (1.3) | 3 (3.7) | 64.5 (–234.0 to 96.2) |
.621 | 2 (2.4) | 6 (7.7) | 69.0 (–48.8 to 93.6) |
.156 | 3 (1.9) | 9 (5.6) | 66.9 (–20.1 to 90.9) |
.086 |
| PCR-CI excluding B/Yamagata | 1 (1.3) | 2 (2.4) | 46.8 (–475.4 to 95.1) |
.999 | 2 (2.4) | 6 (7.7) | 69.0 (–48.8 to 93.6) |
.156 | 3 (1.9) | 8 (5.0) | 62.7 (–37.9 to 89.9) |
.138 |
| Serologically diagnosed A/H1N1pdm09 | 1 (1.3) | 13 (15.9) | 91.8 (38.9–98.6) |
.001 | 4 (4.8) | 4 (5.1) | 71.4 (–258.6 to 76.0) |
.999 | 5 (3.1) | 17 (10.6) | 70.8 (22.7–89.0) |
.008 |
| Serologically diagnosed A/H3N2 | 5 (6.5) | 17 (20.7) | 68.7 (19.2–87.9) |
.011 | 15 (17.9) | 20 (25.6) | 30.4 (–26.2 to 61.6) |
.229 | 20 (12.4) | 37 (23.1) | 46.3 (11.6–67.4) |
.012 |
| Serologically diagnosed B/Victoria | 1 (1.3) | 14 (17.1) | 92.4 (43.5–99.0) |
.001 | 0 | 3 (3.8) | 1 | .109 | 1 (0.6) | 17 (10.6) | 94.2 (56.6–99.2) |
<.001 |
| Serologically diagnosed infection for at least 1 strain | 7 (9.1) | 32 (39.0) | 76.7 (50.4–89.1) |
<.001 | 16 (19.0) | 24 (30.8) | 38.1 (–75.6 to 64.4) |
.084 | 23 (14.3) | 56 (35.0) | 59.2 (37.0–73.5) |
<.001 |
| Composite SDI or PCR-CI A/H1N1pdm09 | 1 (1.3) | 13 (15.9) | 91.8 (38.9–98.6) |
.001 | 4 (4.8) | 4 (5.1) | 71.4 (–258.6 to 76.0) |
.999 | 5 (3.1) | 17 (10.6) | 70.8 (22.7–89.0) |
.008 |
| Composite SDI or PCR-CI A/H3N2 | 6 (7.8) | 17 (20.7) | 62.4 (9.6–84.4) |
.020 | 16 (19.0) | 22 (28.2) | 32.5 (–188.7 to 61.6) |
.169 | 22 (13.7) | 39 (24.5) | 43.9 (9.9–65.1) |
.015 |
| Composite SDI or PCR-CI B/Victoria | 1 (1.3) | 14 (17.1) | 92.4 (43.5–99.0) |
.001 | 0 | 4 (5.1) | 1 | .052 | 1 (6.2) | 18 (11.3) | 94.5 (59.1–99.3) |
<.001 |
| Overall composite SDI or PCR-CI (including B/Yamagata) | 8 (10.4) | 32 (39.0) | 73.4 (45.9–87.9) |
<.001 | 17 (20.2) | 27 (34.6) | 41.5 (1.4–65.3) |
.040 | 25 (15.5) | 59 (36.9) | 57.9 (36.3–72.1) |
<.001 |
| Overall composite SDI or PCR-CI (excluding B/Yamagata) | 8 (10.4) | 32 (39.0) | 73.4 (45.9–87.9) |
<.001 | 17 (20.2) | 27 (34.6) | 41.5 (1.4–65.3) |
.040 | 25 (15.5) | 59 (36.9) | 57.9 (36.3–72.1) |
<.001 |
Abbreviations: CI, confidence interval; IIV, trivalent inactivated influenza vaccine; PCR-CI, polymerase chain reaction–confirmed influenza illness; SD, standard deviation; SDI, serologically diagnosed influenza infection; VE, vaccine efficacy.