Skip to main content

Table 2 Immunogenicity of vaccine without HSA and licensed varicella vaccines six weeks after doses 1 and 2 (according-to-protocol immunogenicity cohort N = 233)

From: Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial

Dose Group A
Varicella vaccine without HSA
Group B
Licensed varicella vaccine
Ratio (Group A/Group B)
Post-dose 1
N SC % (95 % CI) GMT (95 % CI) N SC (95 % CI) GMT (95 % CI) GMT (95 % CI)
IFA
6 weeks Post-dose 1 116 98.3 (93.9; 99.8) 172.6 (141.6; 210.3) 115 99.1 (95.3; 100) 154.3(128.7; 185.0) 1.12 (0.86; 1.46)
6 weeks Post-dose 2 115 100 (96.8; 100) 1452.5 (1240.7; 1700.5) 112 100 (96.8; 100) 1395.4 (1183.0; 1645.9)
Dose N SR (95 % CI) GMC (95 % CI) N SR (95 % CI) GMC (95 % CI) GMC (95 % CI)
ELISA
6 weeks Post-dose 1 116 98.3 (93.9; 99.8) 123.5(107.9; 141.4) 115 98.3 (93.9; 99.8) 110.7 (98.4; 124.6) 1.12 (0.93; 1.33)
6 weeks Post-dose 2 116 100 (96.9; 100) 1013.6 (880.9; 1166.4) 114 100 (96.8;100) 999.2 (877.3; 1138.1)
  1. N: total number of subjects
  2. 95 % CI: 95 % confidence interval
  3. SC %: seroconversion rate
  4. SR %: Seroresponse rate
  5. GMT: geometric mean antibody titre calculated on all subjects by IFA
  6. GMC: geometric mean antibody concentration calculated on all subjects by ELISA
  7. Criteria for non-inferiority:
  8. The lower limit of the 95 % confidence interval (CI) for the GMT ratio (derived by IFA) between Group A and Group B is equal to or above the pre-defined clinical limit of 0.5
  9. The lower limit of the 95 % CI for the GMC ratio (derived from ELISA) between Group A and Group B is equal to or above the pre-defined clinical limit of 0.67