Immune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled study

Table 4 Difference between groups in the percentage of participants reporting grade 3 solicited and unsolicited symptoms

Symptoms	ACWY-TT			Men-PS			Difference in percentage (ACWY-TT minus Men-PS)
	N	n	%	N	n	%	% [95% CI]
Any symptom	374	12	3.2	126	1	0.8	2.41 [−1.29, 4.91]
General symptom	374	5	1.3	126	0	0.0	1.34 [−1.64, 3.09]
Local symptom	374	9	2.4	126	1	0.8	1.61 [−2.06, 3.90]

ACWY-TT = group of participants who received one dose of MenACWY-TT at Month 0.
Men-PS = group of participants who received one dose of the MenACWY polysaccharide vaccine at Month 0.
N = number of participants with the administered dose (total vaccinated cohort).
n/% = number/percentage of participants reporting a specified symptom during the four-day post-vaccination period.
95% CI = standardised asymptotic 95% confidence interval.
Bold = upper limits of the 95% confidence intervals of the differences in percentages of participants reporting grade 3 general symptoms, which were used to demonstrate non-inferiority (co-primary objective).

ISSN: 1471-2334