Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02D malaria vaccine in infants living in a malaria-endemic region

Table 6 Vaccine efficacy against P. falciparum disease (ATP Cohort for Efficacy)

RTS,S/AS02_D			Hepatitis B Vaccine			Point estimate of VE adjusted for covariates
Subjects (N)	No. of events	PYAR	Subjects (N)	No. of events	PYAR	(%)	95% CI		P value
Primary Case Definition: multiple episodes
Months 2.5 – 14
146	18	124.48	151	30	127.91	50.7	−6.5	77.1	0.072
Months 2.5 – 20
146	42	193.41	151	51	198.29	26.7	−33.1	59.6	0.307
Primary Case Definition: first or only
Months 2.5 – 14
146	13	121.04	151	24	121.34	53.6	8.6	76.4	0.026
Months 2.5 – 20
146	26	181.92	151	34	178.56	34.9	−8.8	61.1	0.101

PYAR: Episodes/Person Years at Risk; VE: Vaccine Efficacy (1-HR); CI: Confidence Interval; p value from Cox PH model; Poisson regression for multiple episodes.

ISSN: 1475-2875