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Table 5 Study in children: haemagglutinin inhibition (HI) antibodies to A/California/7/2009 (H1N1)v-like strain after vaccination (ATP cohorts for immunogenicity and persistence)

From: Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials

Group Time Seroconversion rate Seroconversion factor Seroprotection rate
  point N % (95% CI) N Ratio (95% CI) N % ≥1:40 (95% CI)
Q-Pan0.9 Pre - - - - - - 76 36.8 (26.1; 48.7)
Day 21 76 98.7 (92.9; 100) 76 25.7 (20.7; 32.0) 76 98.7 (92.9; 100)
Month 6 73 63.0 (50.9; 74.0) 73 6.6 (5.4; 8.2) 73 75.3 (63.9; 84.7)
D-Pan0.9 Pre - - - - - - 75 32.0 (21.7; 43.8)
Day 21 75 98.7 (92.8; 100) 75 27.1 (22.4; 32.8) 75 98.7 (92.8; 100)
Month 6 74 71.6 (59.9; 81.5) 74 8.0 (6.4; 10.1) 74 85.1 (75.0; 92.3)
Q-Pan1.9 Pre - - - - - - 58 31.0 (19.5; 44.5)
Day 21 58 98.3 (90.8; 100) 58 32.2 (24.7; 42.0) 58 98.3 (90.8; 100)
  Month 6 58 69.0 (55.5; 80.5) 58 8.9 (6.8; 11.7) 58 79.3 (66.6; 88.8)
  1. N number of subjects with available results (for seroconversion rate and seroconversion factor N - the number of subjects with pre- and post-vaccination results available); % - percentage of subjects; 95% CI - 95% confidence interval. Seroconversion: For initially seronegative subjects (i.e., HI titres <1:10), antibody titre≥ 1:40 after vaccination. For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre. Seroconversion Factor - Geometric Mean Ratio (mean[log10(post-vaccination GMT/pre vaccination GMT]). Pre - prior to vaccination, Day 21 etc- 21 days post vaccination. CBER Criteria were fulfilled if: the lower limit of the 95% CI for SCR was >40%, and the lower limit of the 95% CI for % ≥1:40 was > 70%. CHMP Criteria were fulfilled if: the point estimate for SCR was > 40% and, the post-vaccination point estimate for % ≥1:40 was > 70% and, the point estimate for SCF was >2.5. See Table 1 for details of treatment groups.