Skip to main content

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

From: 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

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]
  1. ACWY-TT = group of participants who received one dose of MenACWY-TT at Month 0.
  2. Men-PS = group of participants who received one dose of the MenACWY polysaccharide vaccine at Month 0.
  3. N = number of participants with the administered dose (total vaccinated cohort).
  4. n/% = number/percentage of participants reporting a specified symptom during the four-day post-vaccination period.
  5. 95% CI = standardised asymptotic 95% confidence interval.
  6. 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).