|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).
Borja-Tabora et al.
Borja-Tabora et al. BMC Infectious Diseases 2013 13:116 doi:10.1186/1471-2334-13-116