Table 2.

Primary vaccination study (NCT00464815): Difference between groups in percentage of subjects with rSBA vaccine response one month after vaccination (Primary ATP immunogenicity re-analysis cohort).

	MenACWY-TT			Men-PS			Difference in VR rate (ACWY-TT minus Men-PS)
Serogroup	N	n	%VR [95% CI]	N	n	% VR [95% CI]	% [95% CI]
A	553	472	85.4** [82.1; 88.2]	191	148	77.5 [70.9; 83.2]	7.87 [1.63*; 14.87]
C	642	625	97.4 [95.8; 98.5]	211	204	96.7 [93.3; 98.7]	0.67 [−1.65*; 4.18]
W	639	616	96.4** [94.6; 97.7]	216	189	87.5 [82.3; 91.6]	8.90 [4.78*; 14.14]
Y	657	616	93.8** [91.6; 95.5]	219	172	78.5 [72.5; 83.8]	15.22 [9.89*; 21.37]

ATP = According-to-Protocol

VR = vaccine response defined as:

For initially seronegative subjects: antibody titer ≥ 1:32 post-vaccination

For initially seropositive subjects: antibody titer post-vaccination that is ≥ 4-fold the pre-vaccination antibody titer

N = number of subjects with both pre- and post-vaccination results available

n/% = number/percentage of subjects with a vaccine response

95% CI = exact 95% confidence interval

^*Lower limit of 95% CI was above pre-specified clinical non-inferiority limit of −10%

^**statistically higher value in ACWY-TT group than in Men-PS group (exploratory analysis)