Table 2.

Non-inferiority assessment of the anti-CS and anti-HBs antibody responses at 1 month after the third dose of RTS,S/AS01 vaccine (RTS,S coad and RTS,S alone groups) and of the anti-measles, anti-rubella and anti-YF antibody responses at 1 month after the MR and YF vaccination (RTS,S coad and Control groups) - per-protocol set.

	RTS,S alone		RTS,S coad		GMC ratio (RTS,S alone/RTS,S coad)
Antibody	N	GMC (95% CI)	N	GMC (95% CI)	Value (95% CI)
Anti-CS (EU/mL)	213	422.49 (382.89–466.18)	207	452.87 (409.85–500.41)	0.93 (0.81–1.07)
Anti-HBs (mIU/mL)	210	43261.19 (36964.93–50629.89)	204	42096.33 (35887.11–49379.88)	1.03 (0.82–1.29)
	RTS,S coad		Control		Absolute difference in percentage (Control minus RTS,S coad)
Antibody	N	% (95% CI)	N	% (95% CI)	% (95% CI)
Anti-measles (mIU/mL)	204	96.08 (92.4–98.3)	216	98.15 (95.3–99.5)	2.07 (-1.27–5.92)
Anti-rubella (IU/mL)	199	99.50 (97.2–100.0)	212	100.00 (98.3–100.0)	0.50 (-1.29–2.80)
Anti-YF (ED50)	206	98.06 (95.1–99.5)	216	98.61 (96.0–99.7)	0.55 (-2.31–3.67)

The RTS,S coad group received the RTS,S/AS01 vaccines at 6, 7.5 and 9 months of age and the YF and MR vaccines at 9 months of age; the RTS,S alone group received the RTS,S/AS01 vaccines at 6, 7.5 and 9 months of age; and the Control group received the YF and MR vaccines at 9 months of age.

N, number of children with seronegative results at pre-vaccination and available post-vaccination results (for anti-measles and anti-rubella antibodies) or number of children with post-vaccination results available (anti-CS, anti-HBs and anti-YF antibodies); GMC, geometric mean concentration; CI, confidence interval; CS, circumsporozoite; HBs, hepatitis B surface antigens; %, percentage of seropositive (anti-YF), or seroconverted (anti-measles and anti-rubella children at 1 month post-vaccination; YF, yellow fever; MR, combined measles-rubella.

Bold: primary objective of the study.