Figure 2.
A–D, Boxplots of enzyme immunoassay, palivizumab-competitive antibody, and respiratory syncytial virus (RSV) subtypes A and B infant cord blood (Cord) levels by case/control status (A and C, endpoint 1 cases; B and D, endpoint 2 cases) in the vaccine arm (A and B) or the placebo arm (C and D). E–H, Odds ratios in the vaccine arm (E and F) or the placebo arm (G and H) of experiencing RSV disease defined by endpoint 1 (E and G) or endpoint 2 (F and H) per 10-fold increase in the designated immunologic biomarker, based on logistic regression modeling adjusting for maternal risk score and number of days from vaccination to birth. Cases were defined as infants in the correlates analysis cohort with an RSV illness defined by endpoint 1 or endpoint 2 (as appropriate) through 90 days of age in the expanded data set. Controls were defined as infants 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. Endpoint 1 was defined as medically significant RSV-associated lower respiratory tract infection (LRTI), RSV-associated LRTI with hospitalization, or RSV-associated LRTI with severe hypoxemia (52 vaccine endpoints). Endpoint 2 was defined as RSV-associated LRTI with severe hypoxemia (14 vaccine endpoints). Abbreviations: BH, false-discovery rate (q value, Benjamini-Hochberg) adjustment applied separately for the vaccine arm; CI, confidence interval; Cord, infant cord blood; EIA, enzyme immunoassay; Holm, family-wise error rate (Holm-Bonferroni); OR, odds ratio; PCA, palivizumab-competitive antibody; RSV-A, respiratory syncytial virus subtype A; RSV-B, respiratory syncytial virus subtype B.

AD, Boxplots of enzyme immunoassay, palivizumab-competitive antibody, and respiratory syncytial virus (RSV) subtypes A and B infant cord blood (Cord) levels by case/control status (A and C, endpoint 1 cases; B and D, endpoint 2 cases) in the vaccine arm (A and B) or the placebo arm (C and D). EH, Odds ratios in the vaccine arm (E and F) or the placebo arm (G and H) of experiencing RSV disease defined by endpoint 1 (E and G) or endpoint 2 (F and H) per 10-fold increase in the designated immunologic biomarker, based on logistic regression modeling adjusting for maternal risk score and number of days from vaccination to birth. Cases were defined as infants in the correlates analysis cohort with an RSV illness defined by endpoint 1 or endpoint 2 (as appropriate) through 90 days of age in the expanded data set. Controls were defined as infants 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. Endpoint 1 was defined as medically significant RSV-associated lower respiratory tract infection (LRTI), RSV-associated LRTI with hospitalization, or RSV-associated LRTI with severe hypoxemia (52 vaccine endpoints). Endpoint 2 was defined as RSV-associated LRTI with severe hypoxemia (14 vaccine endpoints). Abbreviations: BH, false-discovery rate (q value, Benjamini-Hochberg) adjustment applied separately for the vaccine arm; CI, confidence interval; Cord, infant cord blood; EIA, enzyme immunoassay; Holm, family-wise error rate (Holm-Bonferroni); OR, odds ratio; PCA, palivizumab-competitive antibody; RSV-A, respiratory syncytial virus subtype A; RSV-B, respiratory syncytial virus subtype B.

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