Antibody Levels in Mothers (Placebo Recipients) and Their Infants by Case/Control Outcome Status
| Marker . | Controlsa . | Cases, Endpoint 1b . | Cases, Endpoint 2c . | Case/Control Comparison . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comparison for Endpoint 1 Cases . | Comparison for Endpoint 1 Cases . | ||||||||||||
| No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | GMT or GMC Ratio (95% CI) . | GM Fold-Rise Ratio (95% CI) . | GMT or GMC Ratio (95% CI) . | GM Fold-Rise Ratio (95% CI) . | |
| EIA D0 | 724 | 549 (108–2783) | NA | 51 | 532 (122–2312) | NA | 27 | 565 (151–2119) | … | 1.0 (.1–8.7) | NA | 1.0 (.1–8.4) | NA |
| PCA D0 | 724 | 13 (4–48) | NA | 51 | 14 (4–49) | NA | 27 | 16 (5–54) | … | 1.1 (.2–6.4) | NA | 1.2 (.2–7.1) | NA |
| RSV-A D0 | 104 | 792 (167–3752) | NA | 51 | 681 (123–3760) | NA | 27 | 740 (130–4206) | … | 0.9 (.1–8.7) | NA | 0.9 (.1–9.6) | NA |
| RSV-B D0 | 104 | 583 (97–3503) | NA | 51 | 517 (61–4412) | NA | 27 | 509 (64–4040) | … | 0.9 (.1–14.5) | NA | 0.9 (.1–13.5) | NA |
| EIA D14 | 702 | 569 (114–2847) | 1 (0–3) | 47 | 527 (131–2122) | 1 (0–2) | 25 | 562 (154–2051) | 1 (0–2) | 0.9 (.1–7.8) | 1.0 (.3–3.5) | 1.0 (.1–7.8) | 1.0 (.3–3.4) |
| PCA D14 | 702 | 12 (3–45) | 1 (0–2) | 47 | 12 (4–36) | 1 (0–2) | 25 | 12 (4–34) | 1 (0–2) | 1.0 (.2–5.3) | 0.9 (.3–2.7) | 1.0 (.2–5.1) | 0.8 (.2–2.8) |
| RSV-A D14 | 104 | 772 (161–3692) | 1 (0–4) | 51 | 668 (133–3367) | 1 (0–3) | 27 | 660 (149–2925) | 1 (0–3) | 0.9 (.1–8.2) | 1.0 (.2–6.4) | 0.9 (.1–7.4) | 0.9 (.2–5.3) |
| RSV-B D14 | 104 | 556 (76–4063) | 1 (0–3) | 51 | 465 (70–3115) | 1 (0–3) | 27 | 430 (69–2665) | 1 (0–2) | 0.8 (.1–13.1) | 0.9 (.2–5.0) | 0.8 (.1–11.5) | 0.9 (.2–4.1) |
| EIA Cord | 686 | 625 (127–3071) | 1 (0–4) | 48 | 648 (153–2755) | 1 (0–4) | 25 | 664 (166–2646) | 1 (0–3) | 1.0 (.1–8.9) | 1.1 (.2–5.6) | 1.1 (.1–8.8) | 1.0 (.2–4.8) |
| PCA Cord | 680 | 13 (3–48) | 1 (0–3) | 48 | 14 (5–41) | 1 (0–2) | 25 | 14 (5–40) | 1 (0–2) | 1.1 (.2–6.0) | 1.0 (.3–3.8) | 1.1 (.2–6.0) | 0.9 (.2–3.8) |
| RSV-A Cord | 104 | 694 (151–3186) | 1 (0–3) | 51 | 614 (121–3111) | 1 (0–3) | 27 | 663 (142–3104) | 1 (0–3) | 0.9 (.1–8.2) | 1.0 (.2–5.1) | 1.0 (.1–8.4) | 1.0 (.2–5.3) |
| RSV-B Cord | 104 | 582 (83–4083) | 1 (0–4) | 51 | 506 (58–4435) | 1 (0–4) | 27 | 510 (50–5178) | 1 (0–3) | 0.9 (.0–16.1) | 1.0 (.1–7.3) | 0.9 (.0–18.1) | 1.0 (.2–6.5) |
| Marker . | Controlsa . | Cases, Endpoint 1b . | Cases, Endpoint 2c . | Case/Control Comparison . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comparison for Endpoint 1 Cases . | Comparison for Endpoint 1 Cases . | ||||||||||||
| No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | GMT or GMC Ratio (95% CI) . | GM Fold-Rise Ratio (95% CI) . | GMT or GMC Ratio (95% CI) . | GM Fold-Rise Ratio (95% CI) . | |
| EIA D0 | 724 | 549 (108–2783) | NA | 51 | 532 (122–2312) | NA | 27 | 565 (151–2119) | … | 1.0 (.1–8.7) | NA | 1.0 (.1–8.4) | NA |
| PCA D0 | 724 | 13 (4–48) | NA | 51 | 14 (4–49) | NA | 27 | 16 (5–54) | … | 1.1 (.2–6.4) | NA | 1.2 (.2–7.1) | NA |
| RSV-A D0 | 104 | 792 (167–3752) | NA | 51 | 681 (123–3760) | NA | 27 | 740 (130–4206) | … | 0.9 (.1–8.7) | NA | 0.9 (.1–9.6) | NA |
| RSV-B D0 | 104 | 583 (97–3503) | NA | 51 | 517 (61–4412) | NA | 27 | 509 (64–4040) | … | 0.9 (.1–14.5) | NA | 0.9 (.1–13.5) | NA |
| EIA D14 | 702 | 569 (114–2847) | 1 (0–3) | 47 | 527 (131–2122) | 1 (0–2) | 25 | 562 (154–2051) | 1 (0–2) | 0.9 (.1–7.8) | 1.0 (.3–3.5) | 1.0 (.1–7.8) | 1.0 (.3–3.4) |
| PCA D14 | 702 | 12 (3–45) | 1 (0–2) | 47 | 12 (4–36) | 1 (0–2) | 25 | 12 (4–34) | 1 (0–2) | 1.0 (.2–5.3) | 0.9 (.3–2.7) | 1.0 (.2–5.1) | 0.8 (.2–2.8) |
| RSV-A D14 | 104 | 772 (161–3692) | 1 (0–4) | 51 | 668 (133–3367) | 1 (0–3) | 27 | 660 (149–2925) | 1 (0–3) | 0.9 (.1–8.2) | 1.0 (.2–6.4) | 0.9 (.1–7.4) | 0.9 (.2–5.3) |
| RSV-B D14 | 104 | 556 (76–4063) | 1 (0–3) | 51 | 465 (70–3115) | 1 (0–3) | 27 | 430 (69–2665) | 1 (0–2) | 0.8 (.1–13.1) | 0.9 (.2–5.0) | 0.8 (.1–11.5) | 0.9 (.2–4.1) |
| EIA Cord | 686 | 625 (127–3071) | 1 (0–4) | 48 | 648 (153–2755) | 1 (0–4) | 25 | 664 (166–2646) | 1 (0–3) | 1.0 (.1–8.9) | 1.1 (.2–5.6) | 1.1 (.1–8.8) | 1.0 (.2–4.8) |
| PCA Cord | 680 | 13 (3–48) | 1 (0–3) | 48 | 14 (5–41) | 1 (0–2) | 25 | 14 (5–40) | 1 (0–2) | 1.1 (.2–6.0) | 1.0 (.3–3.8) | 1.1 (.2–6.0) | 0.9 (.2–3.8) |
| RSV-A Cord | 104 | 694 (151–3186) | 1 (0–3) | 51 | 614 (121–3111) | 1 (0–3) | 27 | 663 (142–3104) | 1 (0–3) | 0.9 (.1–8.2) | 1.0 (.2–5.1) | 1.0 (.1–8.4) | 1.0 (.2–5.3) |
| RSV-B Cord | 104 | 582 (83–4083) | 1 (0–4) | 51 | 506 (58–4435) | 1 (0–4) | 27 | 510 (50–5178) | 1 (0–3) | 0.9 (.0–16.1) | 1.0 (.1–7.3) | 0.9 (.0–18.1) | 1.0 (.2–6.5) |
Abbreviations: CI, confidence interval; Cord, infant cord blood; D0, day 0; D14, day 14; EIA, enzyme immunoassay; GMC, geometric mean concentration; GMT, geometric mean titer, NA, not applicable; PCA, palivizumab-competitive antibody; RSV-A, respiratory syncytial virus subtype A; RSV-B, respiratory syncytial virus subtype B.
Infants in the correlates analysis cohort who did not experience RSV disease defined by endpoint 1 or endpoint 2 (as appropriate) through 90 days of age in the expanded data set.
Infants in the correlates analysis cohort with medically significant RSV-associated lower respiratory tract infection (LRTI), RSV-associated LRTI with hospitalization, or RSV-associated LRTI with severe hypoxemia through 90 days of age in the expanded data set.
Infants in the correlates analysis cohort with RSV-associated LRTI with severe hypoxemia through 90 days of age in the expanded data set.
Antibody Levels in Mothers (Placebo Recipients) and Their Infants by Case/Control Outcome Status
| Marker . | Controlsa . | Cases, Endpoint 1b . | Cases, Endpoint 2c . | Case/Control Comparison . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comparison for Endpoint 1 Cases . | Comparison for Endpoint 1 Cases . | ||||||||||||
| No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | GMT or GMC Ratio (95% CI) . | GM Fold-Rise Ratio (95% CI) . | GMT or GMC Ratio (95% CI) . | GM Fold-Rise Ratio (95% CI) . | |
| EIA D0 | 724 | 549 (108–2783) | NA | 51 | 532 (122–2312) | NA | 27 | 565 (151–2119) | … | 1.0 (.1–8.7) | NA | 1.0 (.1–8.4) | NA |
| PCA D0 | 724 | 13 (4–48) | NA | 51 | 14 (4–49) | NA | 27 | 16 (5–54) | … | 1.1 (.2–6.4) | NA | 1.2 (.2–7.1) | NA |
| RSV-A D0 | 104 | 792 (167–3752) | NA | 51 | 681 (123–3760) | NA | 27 | 740 (130–4206) | … | 0.9 (.1–8.7) | NA | 0.9 (.1–9.6) | NA |
| RSV-B D0 | 104 | 583 (97–3503) | NA | 51 | 517 (61–4412) | NA | 27 | 509 (64–4040) | … | 0.9 (.1–14.5) | NA | 0.9 (.1–13.5) | NA |
| EIA D14 | 702 | 569 (114–2847) | 1 (0–3) | 47 | 527 (131–2122) | 1 (0–2) | 25 | 562 (154–2051) | 1 (0–2) | 0.9 (.1–7.8) | 1.0 (.3–3.5) | 1.0 (.1–7.8) | 1.0 (.3–3.4) |
| PCA D14 | 702 | 12 (3–45) | 1 (0–2) | 47 | 12 (4–36) | 1 (0–2) | 25 | 12 (4–34) | 1 (0–2) | 1.0 (.2–5.3) | 0.9 (.3–2.7) | 1.0 (.2–5.1) | 0.8 (.2–2.8) |
| RSV-A D14 | 104 | 772 (161–3692) | 1 (0–4) | 51 | 668 (133–3367) | 1 (0–3) | 27 | 660 (149–2925) | 1 (0–3) | 0.9 (.1–8.2) | 1.0 (.2–6.4) | 0.9 (.1–7.4) | 0.9 (.2–5.3) |
| RSV-B D14 | 104 | 556 (76–4063) | 1 (0–3) | 51 | 465 (70–3115) | 1 (0–3) | 27 | 430 (69–2665) | 1 (0–2) | 0.8 (.1–13.1) | 0.9 (.2–5.0) | 0.8 (.1–11.5) | 0.9 (.2–4.1) |
| EIA Cord | 686 | 625 (127–3071) | 1 (0–4) | 48 | 648 (153–2755) | 1 (0–4) | 25 | 664 (166–2646) | 1 (0–3) | 1.0 (.1–8.9) | 1.1 (.2–5.6) | 1.1 (.1–8.8) | 1.0 (.2–4.8) |
| PCA Cord | 680 | 13 (3–48) | 1 (0–3) | 48 | 14 (5–41) | 1 (0–2) | 25 | 14 (5–40) | 1 (0–2) | 1.1 (.2–6.0) | 1.0 (.3–3.8) | 1.1 (.2–6.0) | 0.9 (.2–3.8) |
| RSV-A Cord | 104 | 694 (151–3186) | 1 (0–3) | 51 | 614 (121–3111) | 1 (0–3) | 27 | 663 (142–3104) | 1 (0–3) | 0.9 (.1–8.2) | 1.0 (.2–5.1) | 1.0 (.1–8.4) | 1.0 (.2–5.3) |
| RSV-B Cord | 104 | 582 (83–4083) | 1 (0–4) | 51 | 506 (58–4435) | 1 (0–4) | 27 | 510 (50–5178) | 1 (0–3) | 0.9 (.0–16.1) | 1.0 (.1–7.3) | 0.9 (.0–18.1) | 1.0 (.2–6.5) |
| Marker . | Controlsa . | Cases, Endpoint 1b . | Cases, Endpoint 2c . | Case/Control Comparison . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comparison for Endpoint 1 Cases . | Comparison for Endpoint 1 Cases . | ||||||||||||
| No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | No. . | Absolute Level GMT or GMC (95% CI) . | GM Fold-Rise (95% CI) . | GMT or GMC Ratio (95% CI) . | GM Fold-Rise Ratio (95% CI) . | GMT or GMC Ratio (95% CI) . | GM Fold-Rise Ratio (95% CI) . | |
| EIA D0 | 724 | 549 (108–2783) | NA | 51 | 532 (122–2312) | NA | 27 | 565 (151–2119) | … | 1.0 (.1–8.7) | NA | 1.0 (.1–8.4) | NA |
| PCA D0 | 724 | 13 (4–48) | NA | 51 | 14 (4–49) | NA | 27 | 16 (5–54) | … | 1.1 (.2–6.4) | NA | 1.2 (.2–7.1) | NA |
| RSV-A D0 | 104 | 792 (167–3752) | NA | 51 | 681 (123–3760) | NA | 27 | 740 (130–4206) | … | 0.9 (.1–8.7) | NA | 0.9 (.1–9.6) | NA |
| RSV-B D0 | 104 | 583 (97–3503) | NA | 51 | 517 (61–4412) | NA | 27 | 509 (64–4040) | … | 0.9 (.1–14.5) | NA | 0.9 (.1–13.5) | NA |
| EIA D14 | 702 | 569 (114–2847) | 1 (0–3) | 47 | 527 (131–2122) | 1 (0–2) | 25 | 562 (154–2051) | 1 (0–2) | 0.9 (.1–7.8) | 1.0 (.3–3.5) | 1.0 (.1–7.8) | 1.0 (.3–3.4) |
| PCA D14 | 702 | 12 (3–45) | 1 (0–2) | 47 | 12 (4–36) | 1 (0–2) | 25 | 12 (4–34) | 1 (0–2) | 1.0 (.2–5.3) | 0.9 (.3–2.7) | 1.0 (.2–5.1) | 0.8 (.2–2.8) |
| RSV-A D14 | 104 | 772 (161–3692) | 1 (0–4) | 51 | 668 (133–3367) | 1 (0–3) | 27 | 660 (149–2925) | 1 (0–3) | 0.9 (.1–8.2) | 1.0 (.2–6.4) | 0.9 (.1–7.4) | 0.9 (.2–5.3) |
| RSV-B D14 | 104 | 556 (76–4063) | 1 (0–3) | 51 | 465 (70–3115) | 1 (0–3) | 27 | 430 (69–2665) | 1 (0–2) | 0.8 (.1–13.1) | 0.9 (.2–5.0) | 0.8 (.1–11.5) | 0.9 (.2–4.1) |
| EIA Cord | 686 | 625 (127–3071) | 1 (0–4) | 48 | 648 (153–2755) | 1 (0–4) | 25 | 664 (166–2646) | 1 (0–3) | 1.0 (.1–8.9) | 1.1 (.2–5.6) | 1.1 (.1–8.8) | 1.0 (.2–4.8) |
| PCA Cord | 680 | 13 (3–48) | 1 (0–3) | 48 | 14 (5–41) | 1 (0–2) | 25 | 14 (5–40) | 1 (0–2) | 1.1 (.2–6.0) | 1.0 (.3–3.8) | 1.1 (.2–6.0) | 0.9 (.2–3.8) |
| RSV-A Cord | 104 | 694 (151–3186) | 1 (0–3) | 51 | 614 (121–3111) | 1 (0–3) | 27 | 663 (142–3104) | 1 (0–3) | 0.9 (.1–8.2) | 1.0 (.2–5.1) | 1.0 (.1–8.4) | 1.0 (.2–5.3) |
| RSV-B Cord | 104 | 582 (83–4083) | 1 (0–4) | 51 | 506 (58–4435) | 1 (0–4) | 27 | 510 (50–5178) | 1 (0–3) | 0.9 (.0–16.1) | 1.0 (.1–7.3) | 0.9 (.0–18.1) | 1.0 (.2–6.5) |
Abbreviations: CI, confidence interval; Cord, infant cord blood; D0, day 0; D14, day 14; EIA, enzyme immunoassay; GMC, geometric mean concentration; GMT, geometric mean titer, NA, not applicable; PCA, palivizumab-competitive antibody; RSV-A, respiratory syncytial virus subtype A; RSV-B, respiratory syncytial virus subtype B.
Infants in the correlates analysis cohort who did not experience RSV disease defined by endpoint 1 or endpoint 2 (as appropriate) through 90 days of age in the expanded data set.
Infants in the correlates analysis cohort with medically significant RSV-associated lower respiratory tract infection (LRTI), RSV-associated LRTI with hospitalization, or RSV-associated LRTI with severe hypoxemia through 90 days of age in the expanded data set.
Infants in the correlates analysis cohort with RSV-associated LRTI with severe hypoxemia through 90 days of age in the expanded data set.
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