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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