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Table 4 Study in adults: 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 N Seroconversion rate Seroconversion factor Seroprotection rate
  point   % (95% CI) Ratio (95% CI) %≥1:40 (95% CI)
Q-Pan Pre 164 - - - - 13.4 (8.6; 19.6)
Day 21 164 93.9 (89.1; 97.0) 32.0 (26.5; 38.6) 97.6 (93.9; 99.3)
Day 42 155 98.7 (95.4; 99.8) 63.2 (52.6; 75.9) 100 (97.6; 100)
Month 6 154 91.6 (86.0; 95.4) 21.7 (18.1; 25.9) 97.4 (93.5; 99.3)
Month 12 146 72.6 (64.6; 79.7) 11.0 (9.1; 13.3) 82.9 (75.8; 88.6)
D-Pan Pre 164 - - - - 11.6 (7.1; 17.5)
Day 21 164 97.6 (93.9; 99.3) 41.5 (34.3; 50.2) 100 (97.8; 100)
Day 42 155 99.4 (96.5; 100) 63.0 (52.2; 76.1) 100 (97.6; 100)
Month 6 156 92.3 (86.9; 96.0) 22.0 (18.5; 26.1) 96.8 (92.7; 99.0)
  Month 12 144 75.7 (67.9; 82.4) 11.0 (9.2; 13.2) 84.0 (77.0; 89.6)
  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, post-vaccination HI titre ≥ 4 fold the pre-vaccination antibody titre. Seroconversion Factor -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.