All-Cause Admission Incidence and Case-Fatality Risk Within 6 Months, by BCG Strain and Sex
| All-Cause Hospital Admissions by 6 Months of Age . | ||||||||
|---|---|---|---|---|---|---|---|---|
| Sex . | Admission Rate per PY (Admissions/PY) . | Japan/Russia 6-Month Admission IRR (95% CI)a . | P Value for Interaction With Sex . | Case-Fatality Risk, % (Deaths/Admissions) . | Japan/Russia 6-Month Case-Fatality RR (95% CI)b . | P Value for Interaction With Sex . | ||
| BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | |||||
| n = 8754 | n = 8752 | n = 8754 | n = 8752 | |||||
| Male | 0.15 (342/2209) | 0.18 (397/2194) | 0.86 (.74–.99)c | 7.6% (26/342) | 9.6% (38/397) | 0.78 (.48–1.27) | ||
| Female | 0.13 (276/2054) | 0.14 (282/2068) | 0.99 (.84–1.17) | .21 | 12% (32/276) | 7.8% (22/282) | 1.52 (.90–2.59) | .07 |
| Total | 0.14 (618/4263) | 0.16 (679/4261) | 0.92 (.82–1.02) | 9.4% (58/618) | 8.8% (60/679) | 1.06 (.75–1.51) | ||
| Mother has a BCG scard | ||||||||
| n = 5584 | n = 5486 | n = 5584 | n = 5486 | |||||
| Male | 0.16 (224/1404) | 0.18 (249/1384) | 0.89 (.74–1.07) | 5.4% (12/224) | 8.0% (20/249) | 0.66 (.33–1.34) | ||
| Female | 0.14 (183/1321) | 0.13 (174/1291) | 1.03 (.84–1.27) | .28 | 12% (22/183) | 7.5% (13/174) | 1.69 (.87–3.30) | .06 |
| Total | 0.15 (407/2725) | 0.16 (423/2675) | 0.95 (.83–1.09) | 8.4% (34/407) | 7.8% (33/423) | 1.09 (.68–1.75) | ||
| Mother has no BCG scar | ||||||||
| n = 3037 | n = 3168 | n = 3037 | n = 3168 | |||||
| Male | 0.14 (111/771) | 0.17 (137/790) | 0.84 (.65–1.07) | 13% (14/111) | 11% (15/137) | 1.12 (.55–2.26) | ||
| Female | 0.12 (86/703) | 0.14 (102/751) | 0.91 (.68–1.21)e | .21 | 10% (9/86) | 6.9% (7/102) | 1.50 (.57–3.94) | .63 |
| Total | 0.13 (197/1474) | 0.16 (239/1541) | 0.87 (.72–1.05) | 12% (23/197) | 9.2% (22/239) | 1.24 (.70–2.18) | ||
| All-Cause Hospital Admissions by 6 Months of Age . | ||||||||
|---|---|---|---|---|---|---|---|---|
| Sex . | Admission Rate per PY (Admissions/PY) . | Japan/Russia 6-Month Admission IRR (95% CI)a . | P Value for Interaction With Sex . | Case-Fatality Risk, % (Deaths/Admissions) . | Japan/Russia 6-Month Case-Fatality RR (95% CI)b . | P Value for Interaction With Sex . | ||
| BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | |||||
| n = 8754 | n = 8752 | n = 8754 | n = 8752 | |||||
| Male | 0.15 (342/2209) | 0.18 (397/2194) | 0.86 (.74–.99)c | 7.6% (26/342) | 9.6% (38/397) | 0.78 (.48–1.27) | ||
| Female | 0.13 (276/2054) | 0.14 (282/2068) | 0.99 (.84–1.17) | .21 | 12% (32/276) | 7.8% (22/282) | 1.52 (.90–2.59) | .07 |
| Total | 0.14 (618/4263) | 0.16 (679/4261) | 0.92 (.82–1.02) | 9.4% (58/618) | 8.8% (60/679) | 1.06 (.75–1.51) | ||
| Mother has a BCG scard | ||||||||
| n = 5584 | n = 5486 | n = 5584 | n = 5486 | |||||
| Male | 0.16 (224/1404) | 0.18 (249/1384) | 0.89 (.74–1.07) | 5.4% (12/224) | 8.0% (20/249) | 0.66 (.33–1.34) | ||
| Female | 0.14 (183/1321) | 0.13 (174/1291) | 1.03 (.84–1.27) | .28 | 12% (22/183) | 7.5% (13/174) | 1.69 (.87–3.30) | .06 |
| Total | 0.15 (407/2725) | 0.16 (423/2675) | 0.95 (.83–1.09) | 8.4% (34/407) | 7.8% (33/423) | 1.09 (.68–1.75) | ||
| Mother has no BCG scar | ||||||||
| n = 3037 | n = 3168 | n = 3037 | n = 3168 | |||||
| Male | 0.14 (111/771) | 0.17 (137/790) | 0.84 (.65–1.07) | 13% (14/111) | 11% (15/137) | 1.12 (.55–2.26) | ||
| Female | 0.12 (86/703) | 0.14 (102/751) | 0.91 (.68–1.21)e | .21 | 10% (9/86) | 6.9% (7/102) | 1.50 (.57–3.94) | .63 |
| Total | 0.13 (197/1474) | 0.16 (239/1541) | 0.87 (.72–1.05) | 12% (23/197) | 9.2% (22/239) | 1.24 (.70–2.18) | ||
A total of 86% (1112/1297) of admissions were due to infection and 14% (185/1297) were due to noninfectious causes. The Japan/Russia IRR for admission due to infectious diseases was 0.92 (95% CI, .82–1.04) overall, 0.87 (95% CI, .75–1.02) for males, and 1.00 (95% CI, .84–1.20) for females. Corresponding case-fatality RRs were 1.09 (95% CI, .72–1.64) overall, 0.74 (95% CI, .42–1.30) for males, and 1.74 (95% CI, .92–3.27) for females.
Abbreviations: BCG, bacillus Calmette-Guérin; CI, confidence interval; IRR, incidence rate ratio; PY, person-years; RR, risk ratio.
aAndersen-Gill recurrent-event Cox proportional hazards model providing IRRs. Three newborns (2 BCG-Russia, 1 BCG-Japan) were lost to follow-up during hospital admission.
bBinomial regression providing RRs.
cP = .049.
dThe maternal BCG scar status was unknown for 1.3% (231/17 506) for the cohort in which there was 22 admissions and 4 in-hospital deaths (11 [1 fatal] BCG-Japan, 11 [3 fatal] BCG-Russia).
eTest of the proportional hazards assumption using Schoenfeld residuals: P = .041.
All-Cause Admission Incidence and Case-Fatality Risk Within 6 Months, by BCG Strain and Sex
| All-Cause Hospital Admissions by 6 Months of Age . | ||||||||
|---|---|---|---|---|---|---|---|---|
| Sex . | Admission Rate per PY (Admissions/PY) . | Japan/Russia 6-Month Admission IRR (95% CI)a . | P Value for Interaction With Sex . | Case-Fatality Risk, % (Deaths/Admissions) . | Japan/Russia 6-Month Case-Fatality RR (95% CI)b . | P Value for Interaction With Sex . | ||
| BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | |||||
| n = 8754 | n = 8752 | n = 8754 | n = 8752 | |||||
| Male | 0.15 (342/2209) | 0.18 (397/2194) | 0.86 (.74–.99)c | 7.6% (26/342) | 9.6% (38/397) | 0.78 (.48–1.27) | ||
| Female | 0.13 (276/2054) | 0.14 (282/2068) | 0.99 (.84–1.17) | .21 | 12% (32/276) | 7.8% (22/282) | 1.52 (.90–2.59) | .07 |
| Total | 0.14 (618/4263) | 0.16 (679/4261) | 0.92 (.82–1.02) | 9.4% (58/618) | 8.8% (60/679) | 1.06 (.75–1.51) | ||
| Mother has a BCG scard | ||||||||
| n = 5584 | n = 5486 | n = 5584 | n = 5486 | |||||
| Male | 0.16 (224/1404) | 0.18 (249/1384) | 0.89 (.74–1.07) | 5.4% (12/224) | 8.0% (20/249) | 0.66 (.33–1.34) | ||
| Female | 0.14 (183/1321) | 0.13 (174/1291) | 1.03 (.84–1.27) | .28 | 12% (22/183) | 7.5% (13/174) | 1.69 (.87–3.30) | .06 |
| Total | 0.15 (407/2725) | 0.16 (423/2675) | 0.95 (.83–1.09) | 8.4% (34/407) | 7.8% (33/423) | 1.09 (.68–1.75) | ||
| Mother has no BCG scar | ||||||||
| n = 3037 | n = 3168 | n = 3037 | n = 3168 | |||||
| Male | 0.14 (111/771) | 0.17 (137/790) | 0.84 (.65–1.07) | 13% (14/111) | 11% (15/137) | 1.12 (.55–2.26) | ||
| Female | 0.12 (86/703) | 0.14 (102/751) | 0.91 (.68–1.21)e | .21 | 10% (9/86) | 6.9% (7/102) | 1.50 (.57–3.94) | .63 |
| Total | 0.13 (197/1474) | 0.16 (239/1541) | 0.87 (.72–1.05) | 12% (23/197) | 9.2% (22/239) | 1.24 (.70–2.18) | ||
| All-Cause Hospital Admissions by 6 Months of Age . | ||||||||
|---|---|---|---|---|---|---|---|---|
| Sex . | Admission Rate per PY (Admissions/PY) . | Japan/Russia 6-Month Admission IRR (95% CI)a . | P Value for Interaction With Sex . | Case-Fatality Risk, % (Deaths/Admissions) . | Japan/Russia 6-Month Case-Fatality RR (95% CI)b . | P Value for Interaction With Sex . | ||
| BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | |||||
| n = 8754 | n = 8752 | n = 8754 | n = 8752 | |||||
| Male | 0.15 (342/2209) | 0.18 (397/2194) | 0.86 (.74–.99)c | 7.6% (26/342) | 9.6% (38/397) | 0.78 (.48–1.27) | ||
| Female | 0.13 (276/2054) | 0.14 (282/2068) | 0.99 (.84–1.17) | .21 | 12% (32/276) | 7.8% (22/282) | 1.52 (.90–2.59) | .07 |
| Total | 0.14 (618/4263) | 0.16 (679/4261) | 0.92 (.82–1.02) | 9.4% (58/618) | 8.8% (60/679) | 1.06 (.75–1.51) | ||
| Mother has a BCG scard | ||||||||
| n = 5584 | n = 5486 | n = 5584 | n = 5486 | |||||
| Male | 0.16 (224/1404) | 0.18 (249/1384) | 0.89 (.74–1.07) | 5.4% (12/224) | 8.0% (20/249) | 0.66 (.33–1.34) | ||
| Female | 0.14 (183/1321) | 0.13 (174/1291) | 1.03 (.84–1.27) | .28 | 12% (22/183) | 7.5% (13/174) | 1.69 (.87–3.30) | .06 |
| Total | 0.15 (407/2725) | 0.16 (423/2675) | 0.95 (.83–1.09) | 8.4% (34/407) | 7.8% (33/423) | 1.09 (.68–1.75) | ||
| Mother has no BCG scar | ||||||||
| n = 3037 | n = 3168 | n = 3037 | n = 3168 | |||||
| Male | 0.14 (111/771) | 0.17 (137/790) | 0.84 (.65–1.07) | 13% (14/111) | 11% (15/137) | 1.12 (.55–2.26) | ||
| Female | 0.12 (86/703) | 0.14 (102/751) | 0.91 (.68–1.21)e | .21 | 10% (9/86) | 6.9% (7/102) | 1.50 (.57–3.94) | .63 |
| Total | 0.13 (197/1474) | 0.16 (239/1541) | 0.87 (.72–1.05) | 12% (23/197) | 9.2% (22/239) | 1.24 (.70–2.18) | ||
A total of 86% (1112/1297) of admissions were due to infection and 14% (185/1297) were due to noninfectious causes. The Japan/Russia IRR for admission due to infectious diseases was 0.92 (95% CI, .82–1.04) overall, 0.87 (95% CI, .75–1.02) for males, and 1.00 (95% CI, .84–1.20) for females. Corresponding case-fatality RRs were 1.09 (95% CI, .72–1.64) overall, 0.74 (95% CI, .42–1.30) for males, and 1.74 (95% CI, .92–3.27) for females.
Abbreviations: BCG, bacillus Calmette-Guérin; CI, confidence interval; IRR, incidence rate ratio; PY, person-years; RR, risk ratio.
aAndersen-Gill recurrent-event Cox proportional hazards model providing IRRs. Three newborns (2 BCG-Russia, 1 BCG-Japan) were lost to follow-up during hospital admission.
bBinomial regression providing RRs.
cP = .049.
dThe maternal BCG scar status was unknown for 1.3% (231/17 506) for the cohort in which there was 22 admissions and 4 in-hospital deaths (11 [1 fatal] BCG-Japan, 11 [3 fatal] BCG-Russia).
eTest of the proportional hazards assumption using Schoenfeld residuals: P = .041.
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