BCG Skin Reaction Prevalence and Risk of Lymphadenitis by BCG Strain in the Subgroup of Infants Reached by Home Visits
| Sex . | Infants With No Visible BCG Skin Reaction . | Mean Size of BCG Skin Reaction . | History of Left Axillary Lymphadenitisa . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| % (no./No.) . | Japan/Russia No Reaction PR (95% CI)b . | Size, mm (SD) . | Reaction Size, MD (95% CI)c . | % (no./No.) . | Japan/Russia RR (95% CI)b . | ||||
| BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | ||||
| Home visits conducted by 2 months of age | |||||||||
| Male | 0.6% (3/534) | 2.0% (11/559) | 0.29 (.08–1.02) | 5.3 (1.4) | 4.8 (1.2) | 0.51 (.35–.67)d | 0.0% (0/530) | 0.4% (2/556) | … |
| Female | 1.0% (5/518) | 1.9% (10/526) | 0.51 (.17–1.48) | 5.2 (1.3) | 4.7 (1.1) | 0.52 (.36–.67)d | 0.2% (1/514) | 0.4% (2/526) | 0.51 (.05–5.63) |
| Total | 0.8% (8/1052) | 1.9% (21/1085) | 0.39 (.17–.88) | 5.2 (1.3) | 4.7 (1.2) | 0.51 (.40–.62)d | 0.1% (1/1044) | 0.4% (4/1082) | 0.26 (.03–2.31) |
| Home visits conducted by 6 months of age | |||||||||
| Male | 1.3% (6/473) | 2.5% (12/489) | 0.52 (.20–1.37) | 5.1 (1.6) | 4.5 (1.3) | 0.54 (.33–.76)d | 0.0% (0/471) | 0.2% (1/485) | … |
| Female | 0.4% (2/486) | 2.1% (10/471) | 0.19 (.04–.88) | 5.1 (1.3) | 4.4 (1.3) | 0.66 (.46–.85)d | 0.2% (1/485) | 0.0% (0/468) | … |
| Total | 0.8% (8/959) | 2.3% (22/960) | 0.36 (.16–.81) | 5.1 (1.5) | 4.5 (1.3) | 0.61 (.46–.74)d | 0.1% (1/956) | 0.1% (1/953) | 1.00 (.06–15.9) |
| Sex . | Infants With No Visible BCG Skin Reaction . | Mean Size of BCG Skin Reaction . | History of Left Axillary Lymphadenitisa . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| % (no./No.) . | Japan/Russia No Reaction PR (95% CI)b . | Size, mm (SD) . | Reaction Size, MD (95% CI)c . | % (no./No.) . | Japan/Russia RR (95% CI)b . | ||||
| BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | ||||
| Home visits conducted by 2 months of age | |||||||||
| Male | 0.6% (3/534) | 2.0% (11/559) | 0.29 (.08–1.02) | 5.3 (1.4) | 4.8 (1.2) | 0.51 (.35–.67)d | 0.0% (0/530) | 0.4% (2/556) | … |
| Female | 1.0% (5/518) | 1.9% (10/526) | 0.51 (.17–1.48) | 5.2 (1.3) | 4.7 (1.1) | 0.52 (.36–.67)d | 0.2% (1/514) | 0.4% (2/526) | 0.51 (.05–5.63) |
| Total | 0.8% (8/1052) | 1.9% (21/1085) | 0.39 (.17–.88) | 5.2 (1.3) | 4.7 (1.2) | 0.51 (.40–.62)d | 0.1% (1/1044) | 0.4% (4/1082) | 0.26 (.03–2.31) |
| Home visits conducted by 6 months of age | |||||||||
| Male | 1.3% (6/473) | 2.5% (12/489) | 0.52 (.20–1.37) | 5.1 (1.6) | 4.5 (1.3) | 0.54 (.33–.76)d | 0.0% (0/471) | 0.2% (1/485) | … |
| Female | 0.4% (2/486) | 2.1% (10/471) | 0.19 (.04–.88) | 5.1 (1.3) | 4.4 (1.3) | 0.66 (.46–.85)d | 0.2% (1/485) | 0.0% (0/468) | … |
| Total | 0.8% (8/959) | 2.3% (22/960) | 0.36 (.16–.81) | 5.1 (1.5) | 4.5 (1.3) | 0.61 (.46–.74)d | 0.1% (1/956) | 0.1% (1/953) | 1.00 (.06–15.9) |
Abbreviations: CI, confidence interval; MD, mean difference; PR, prevalence ratio; RR, risk ratio; SD, standard deviation.
aHistory of left axillary lymphadenitis reported by the mother/guardian.
bBinomial regression.
cStudent t test providing estimates of MD in BCG reaction size (height + width divided by 2) between intervention and control groups.
dP < .001.
BCG Skin Reaction Prevalence and Risk of Lymphadenitis by BCG Strain in the Subgroup of Infants Reached by Home Visits
| Sex . | Infants With No Visible BCG Skin Reaction . | Mean Size of BCG Skin Reaction . | History of Left Axillary Lymphadenitisa . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| % (no./No.) . | Japan/Russia No Reaction PR (95% CI)b . | Size, mm (SD) . | Reaction Size, MD (95% CI)c . | % (no./No.) . | Japan/Russia RR (95% CI)b . | ||||
| BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | ||||
| Home visits conducted by 2 months of age | |||||||||
| Male | 0.6% (3/534) | 2.0% (11/559) | 0.29 (.08–1.02) | 5.3 (1.4) | 4.8 (1.2) | 0.51 (.35–.67)d | 0.0% (0/530) | 0.4% (2/556) | … |
| Female | 1.0% (5/518) | 1.9% (10/526) | 0.51 (.17–1.48) | 5.2 (1.3) | 4.7 (1.1) | 0.52 (.36–.67)d | 0.2% (1/514) | 0.4% (2/526) | 0.51 (.05–5.63) |
| Total | 0.8% (8/1052) | 1.9% (21/1085) | 0.39 (.17–.88) | 5.2 (1.3) | 4.7 (1.2) | 0.51 (.40–.62)d | 0.1% (1/1044) | 0.4% (4/1082) | 0.26 (.03–2.31) |
| Home visits conducted by 6 months of age | |||||||||
| Male | 1.3% (6/473) | 2.5% (12/489) | 0.52 (.20–1.37) | 5.1 (1.6) | 4.5 (1.3) | 0.54 (.33–.76)d | 0.0% (0/471) | 0.2% (1/485) | … |
| Female | 0.4% (2/486) | 2.1% (10/471) | 0.19 (.04–.88) | 5.1 (1.3) | 4.4 (1.3) | 0.66 (.46–.85)d | 0.2% (1/485) | 0.0% (0/468) | … |
| Total | 0.8% (8/959) | 2.3% (22/960) | 0.36 (.16–.81) | 5.1 (1.5) | 4.5 (1.3) | 0.61 (.46–.74)d | 0.1% (1/956) | 0.1% (1/953) | 1.00 (.06–15.9) |
| Sex . | Infants With No Visible BCG Skin Reaction . | Mean Size of BCG Skin Reaction . | History of Left Axillary Lymphadenitisa . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| % (no./No.) . | Japan/Russia No Reaction PR (95% CI)b . | Size, mm (SD) . | Reaction Size, MD (95% CI)c . | % (no./No.) . | Japan/Russia RR (95% CI)b . | ||||
| BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | BCG-Japan . | BCG-Russia . | ||||
| Home visits conducted by 2 months of age | |||||||||
| Male | 0.6% (3/534) | 2.0% (11/559) | 0.29 (.08–1.02) | 5.3 (1.4) | 4.8 (1.2) | 0.51 (.35–.67)d | 0.0% (0/530) | 0.4% (2/556) | … |
| Female | 1.0% (5/518) | 1.9% (10/526) | 0.51 (.17–1.48) | 5.2 (1.3) | 4.7 (1.1) | 0.52 (.36–.67)d | 0.2% (1/514) | 0.4% (2/526) | 0.51 (.05–5.63) |
| Total | 0.8% (8/1052) | 1.9% (21/1085) | 0.39 (.17–.88) | 5.2 (1.3) | 4.7 (1.2) | 0.51 (.40–.62)d | 0.1% (1/1044) | 0.4% (4/1082) | 0.26 (.03–2.31) |
| Home visits conducted by 6 months of age | |||||||||
| Male | 1.3% (6/473) | 2.5% (12/489) | 0.52 (.20–1.37) | 5.1 (1.6) | 4.5 (1.3) | 0.54 (.33–.76)d | 0.0% (0/471) | 0.2% (1/485) | … |
| Female | 0.4% (2/486) | 2.1% (10/471) | 0.19 (.04–.88) | 5.1 (1.3) | 4.4 (1.3) | 0.66 (.46–.85)d | 0.2% (1/485) | 0.0% (0/468) | … |
| Total | 0.8% (8/959) | 2.3% (22/960) | 0.36 (.16–.81) | 5.1 (1.5) | 4.5 (1.3) | 0.61 (.46–.74)d | 0.1% (1/956) | 0.1% (1/953) | 1.00 (.06–15.9) |
Abbreviations: CI, confidence interval; MD, mean difference; PR, prevalence ratio; RR, risk ratio; SD, standard deviation.
aHistory of left axillary lymphadenitis reported by the mother/guardian.
bBinomial regression.
cStudent t test providing estimates of MD in BCG reaction size (height + width divided by 2) between intervention and control groups.
dP < .001.
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