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).

Borja-Tabora et al.

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

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