Table 3.
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Rotavirus Diarrhea Incidence and Vaccine Efficacy, Intention-to-Treat and Per-Protocol Analyses

AnalysisAll Subjects, % (95% CI)RV1 Arm, % (95% CI)No RV1 Arm, % (95% CI)Risk Difference, % (95% CI)P ValueRR (95% CI)Efficacy % (95% CI)
Year 1 ITT analysis (n = 700)
 RVD25.8 (22.7–29.2)19.1 (15.3–23.6)32.6 (27.8–37.6)13.4 (7.0–19.8)4.0 × 10−51.70 (1.31–2.21)41.2 (23.6–54.8)
 Severe RVD7.6 (5.8–9.8)4.0 (2.4–6.6)11.1 (8.2–14.9)7.1 (3.2–11.2)3.0 × 10−42.78 (1.54–5.02)64.1 (35.1–80.1)
 All-cause diarrhea85.7 (82.9–88.1)85.1 (81.0–88.5)86.3 (82.3–89.5)1.1 (−4.1 to 6.4).661.01 (.95–1.08)1.3 (−4.8 to 7.1)
 Severe all-cause diarrhea33.7 (30.3–37.3)31.4 (26.8–36.5)36.0 (31.1–41.2)4.6 (−2.4 to 11.5).201.14 (.93–1.41)12.7 (−7.5 to 29.1)
Post-vaccination per-protocol analysis (n = 593)
 RVD25.6 (22.3–29.3)16.8 (12.9–21.5)34.2 (29.1–39.8)17.4 (10.5–24.2)6.6 × 10−72.04 (1.51–2.75)51.0 (33.8–63.7)
 Severe RVD7.4 (5.6–9.8)3.1 (1.6–5.8)11.6 (8.5–15.7)8.5 (4.4–12.9)5.0 × 10−53.77 (1.85–7.71)73.5 (45.8–87.0)
 All-cause diarrhea88.7 (85.9–91.0)90.1 (86.1–93.0)87.4 (83.1–90.7)−2.7 (−7.8 to 2.5).300.92 (.92–1.03)−3.1 (−9.2 to 2.7)
 Severe all-cause diarrhea25.5 (22.1–29.1)22.3 (17.9–27.4)28.6 (23.8–33.9)6.3 (−.71 to 13.2).081.28 (.97–1.70)22.1 (−3.0 to 41.1)
AnalysisAll Subjects, % (95% CI)RV1 Arm, % (95% CI)No RV1 Arm, % (95% CI)Risk Difference, % (95% CI)P ValueRR (95% CI)Efficacy % (95% CI)
Year 1 ITT analysis (n = 700)
 RVD25.8 (22.7–29.2)19.1 (15.3–23.6)32.6 (27.8–37.6)13.4 (7.0–19.8)4.0 × 10−51.70 (1.31–2.21)41.2 (23.6–54.8)
 Severe RVD7.6 (5.8–9.8)4.0 (2.4–6.6)11.1 (8.2–14.9)7.1 (3.2–11.2)3.0 × 10−42.78 (1.54–5.02)64.1 (35.1–80.1)
 All-cause diarrhea85.7 (82.9–88.1)85.1 (81.0–88.5)86.3 (82.3–89.5)1.1 (−4.1 to 6.4).661.01 (.95–1.08)1.3 (−4.8 to 7.1)
 Severe all-cause diarrhea33.7 (30.3–37.3)31.4 (26.8–36.5)36.0 (31.1–41.2)4.6 (−2.4 to 11.5).201.14 (.93–1.41)12.7 (−7.5 to 29.1)
Post-vaccination per-protocol analysis (n = 593)
 RVD25.6 (22.3–29.3)16.8 (12.9–21.5)34.2 (29.1–39.8)17.4 (10.5–24.2)6.6 × 10−72.04 (1.51–2.75)51.0 (33.8–63.7)
 Severe RVD7.4 (5.6–9.8)3.1 (1.6–5.8)11.6 (8.5–15.7)8.5 (4.4–12.9)5.0 × 10−53.77 (1.85–7.71)73.5 (45.8–87.0)
 All-cause diarrhea88.7 (85.9–91.0)90.1 (86.1–93.0)87.4 (83.1–90.7)−2.7 (−7.8 to 2.5).300.92 (.92–1.03)−3.1 (−9.2 to 2.7)
 Severe all-cause diarrhea25.5 (22.1–29.1)22.3 (17.9–27.4)28.6 (23.8–33.9)6.3 (−.71 to 13.2).081.28 (.97–1.70)22.1 (−3.0 to 41.1)

Abbreviations: CI, confidence interval; ITT, intention-to-treat; RR, relative risk; RV1, monovalent G1P[8] rotavirus vaccine; RVD, rotavirus diarrhea.

Table 3.
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Rotavirus Diarrhea Incidence and Vaccine Efficacy, Intention-to-Treat and Per-Protocol Analyses

AnalysisAll Subjects, % (95% CI)RV1 Arm, % (95% CI)No RV1 Arm, % (95% CI)Risk Difference, % (95% CI)P ValueRR (95% CI)Efficacy % (95% CI)
Year 1 ITT analysis (n = 700)
 RVD25.8 (22.7–29.2)19.1 (15.3–23.6)32.6 (27.8–37.6)13.4 (7.0–19.8)4.0 × 10−51.70 (1.31–2.21)41.2 (23.6–54.8)
 Severe RVD7.6 (5.8–9.8)4.0 (2.4–6.6)11.1 (8.2–14.9)7.1 (3.2–11.2)3.0 × 10−42.78 (1.54–5.02)64.1 (35.1–80.1)
 All-cause diarrhea85.7 (82.9–88.1)85.1 (81.0–88.5)86.3 (82.3–89.5)1.1 (−4.1 to 6.4).661.01 (.95–1.08)1.3 (−4.8 to 7.1)
 Severe all-cause diarrhea33.7 (30.3–37.3)31.4 (26.8–36.5)36.0 (31.1–41.2)4.6 (−2.4 to 11.5).201.14 (.93–1.41)12.7 (−7.5 to 29.1)
Post-vaccination per-protocol analysis (n = 593)
 RVD25.6 (22.3–29.3)16.8 (12.9–21.5)34.2 (29.1–39.8)17.4 (10.5–24.2)6.6 × 10−72.04 (1.51–2.75)51.0 (33.8–63.7)
 Severe RVD7.4 (5.6–9.8)3.1 (1.6–5.8)11.6 (8.5–15.7)8.5 (4.4–12.9)5.0 × 10−53.77 (1.85–7.71)73.5 (45.8–87.0)
 All-cause diarrhea88.7 (85.9–91.0)90.1 (86.1–93.0)87.4 (83.1–90.7)−2.7 (−7.8 to 2.5).300.92 (.92–1.03)−3.1 (−9.2 to 2.7)
 Severe all-cause diarrhea25.5 (22.1–29.1)22.3 (17.9–27.4)28.6 (23.8–33.9)6.3 (−.71 to 13.2).081.28 (.97–1.70)22.1 (−3.0 to 41.1)
AnalysisAll Subjects, % (95% CI)RV1 Arm, % (95% CI)No RV1 Arm, % (95% CI)Risk Difference, % (95% CI)P ValueRR (95% CI)Efficacy % (95% CI)
Year 1 ITT analysis (n = 700)
 RVD25.8 (22.7–29.2)19.1 (15.3–23.6)32.6 (27.8–37.6)13.4 (7.0–19.8)4.0 × 10−51.70 (1.31–2.21)41.2 (23.6–54.8)
 Severe RVD7.6 (5.8–9.8)4.0 (2.4–6.6)11.1 (8.2–14.9)7.1 (3.2–11.2)3.0 × 10−42.78 (1.54–5.02)64.1 (35.1–80.1)
 All-cause diarrhea85.7 (82.9–88.1)85.1 (81.0–88.5)86.3 (82.3–89.5)1.1 (−4.1 to 6.4).661.01 (.95–1.08)1.3 (−4.8 to 7.1)
 Severe all-cause diarrhea33.7 (30.3–37.3)31.4 (26.8–36.5)36.0 (31.1–41.2)4.6 (−2.4 to 11.5).201.14 (.93–1.41)12.7 (−7.5 to 29.1)
Post-vaccination per-protocol analysis (n = 593)
 RVD25.6 (22.3–29.3)16.8 (12.9–21.5)34.2 (29.1–39.8)17.4 (10.5–24.2)6.6 × 10−72.04 (1.51–2.75)51.0 (33.8–63.7)
 Severe RVD7.4 (5.6–9.8)3.1 (1.6–5.8)11.6 (8.5–15.7)8.5 (4.4–12.9)5.0 × 10−53.77 (1.85–7.71)73.5 (45.8–87.0)
 All-cause diarrhea88.7 (85.9–91.0)90.1 (86.1–93.0)87.4 (83.1–90.7)−2.7 (−7.8 to 2.5).300.92 (.92–1.03)−3.1 (−9.2 to 2.7)
 Severe all-cause diarrhea25.5 (22.1–29.1)22.3 (17.9–27.4)28.6 (23.8–33.9)6.3 (−.71 to 13.2).081.28 (.97–1.70)22.1 (−3.0 to 41.1)

Abbreviations: CI, confidence interval; ITT, intention-to-treat; RR, relative risk; RV1, monovalent G1P[8] rotavirus vaccine; RVD, rotavirus diarrhea.

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