Table 2.

Clinical outcome events comparing infants BCG-vaccinated at birth with infants BCG-vaccinated at age 6 weeks, overall and by sex and birthweight

	Before delayed BCG (age 0–6 weeks)*				After delayed BCG (age 6–10 weeks)†				Total follow-up period
	Frequency in BCG at birth group	Frequency in BCG at 6 weeks group	Hazard ratio (95% CI)	p value	Frequency in BCG at birth group	Frequency in BCG at 6 weeks group	Hazard ratio	p value	Frequency in BCG at birth group	Frequency in BCG at 6 weeks group	Hazard ratio	p value
Infectious presentations
Total	98	129	0·71 (0·53–0·95)	0·023	88	76	1·10 (0·87–1·40)	0·43	186	205	0·91 (0·76–1·10)	0·33
Male	42	62	0·57 (0·36–0·89)	0·013	41	33	1·11 (0·78–1·59)	0·56	83	95	0·84 (0·63–1·11)	0·22
Female	56	67	0·87 (0·59–1·27)	0·47	47	43	1·11 (0·81–1·52)	0·53	103	110	0·99 (0·78–1·25)	0·93
pinteraction between BCG and sex	..	..	..	0·16	..	..	..	0·99	..	..	..	0·37
Birthweight >2500 g	97	115	0·79 (0·59–1·07)	0·12	88	72	1·16 (0·9–1·48)	0·22	185	187	0·99 (0·82–1·19)	0·89
Birthweight ≤2500 g	1	14	0·10 (0·01–0·75)	0·026	0	4	1·31−8 (5·64−9–3·03−8)	<0·0001	1	18	0·07 (0·01–0·45)	0·0061
pinteraction between BCG and birthweight	..	..	..	0·044	..	..	..	<0·0001	..	..	..	0·0045
Serious illness (Integrated Management of Childhood Illness‡)
Total	33	49	0·68 (0·43–1·07)	0·093	26	18	1·45 (0·82–2·58)	0·20	59	67	0·89 (0·62–1·27)	0·51
Male	10	29	0·34 (0·17–0·69)	0·0028	11	8	1·27 (0·53–3·07)	0·59	21	37	0·54 (0·31–0·94)	0·029
Female	23	20	1·19 (0·65–2·17)	0·57	15	10	1·63 (0·77–3·49)	0·20	38	30	1·33 (0·83–2·15)	0·23
pinteraction between BCG and sex	..	..	..	0·0081	..	..	..	0·67	..	..	..	0·014
Birthweight >2500 g	30	43	0·69 (0·43–1·11)	0·13	26	16	1·62 (0·89–2·94)	0·11	56	59	0·94 (0·65–1·38)	0·77
Birthweight ≤2500 g	3	6	0·63 (0·12–3·25)	0·58	0	2	NA	NA	3	8	0·46 (0·09–2·28)	0·34
pinteraction between BCG and birthweight	..	..	..	0·90	..	..	..	NA	..	..	..	0·39

NA=numbers too few to analyse.

^*Comparison of BCG-vaccinated and BCG unvaccinated infants (ie, comparison of BCG + OPV vs OPV).

^†Comparison of infants receiving BCG at birth and infants receiving BCG at age 6 weeks (ie, comparison of DTP–Hib–HepB + PCV + OPV [after BCG] vs DTP–Hib–HepB + PCV + OPV + BCG); date of EPI-vaccinations in the BCG at birth group was used to establish when they moved into the “Post-BCG in the delayed group” follow-up period (usually day 42).

^‡Serious illness in infants younger than 2 months is defined by the following Integrated Management of Childhood Illness criteria: convulsions or a history of convulsions; not feeding well or vomiting everything; lethargy or unconsciousness or moves only when stimulated or no movement at all or stiff neck; fast breathing (>60 beats per min) or chest in-drawing or stridor in calm child or witnessed apnoeic episodes; axillary temperature of at least 37·5°C or less than 35·5°C; sunken eyes or slow skin pinch; or yellow palms and soles.