Table 3. 21 Day Booster response to 7.5 μg clade 1 A/Vietnam/1194/2004/NIBERG-14 6-months after the first vaccination.
| Age group | 18 to 60 years | > 60 years | |||
|---|---|---|---|---|---|
| Primary vaccine dose | 7.5 μg (N = 39) | 30 μg + Adjuvant (N = 38) | 7.5 μg (N = 36) | 30 μg + Adjuvant(N = 41) | |
| EMA threshold | |||||
| GMT (95% CI) | None | 8.67 (6.32; 11.89) | 9.96 (7.17; 13.82) | 11.53 (7.56; 17.59) | 18.8 (12.5; 28.3) |
| GMTR (95% CI) | >2.5 | 1.59 (1.22; 2.06) | 1.45 (1.21; 1.75) | ||
| GMTR (95% CI) | > 2# | 1.31 (1.06; 1.62) | 1.34 (1.09; 1.67) | ||
| Seroconversion* % (95% CI) | > 40% | 10.3 (2.9; 24.2) | 2.6 (0.1; 13.8) | ||
| Seroconversion* % (95% CI) | > 30%# | 2.8 (0.1; 14.5) | 9.8 (2.7; 23.1) | ||
| Seroprotection (titre ≥ 40) % (95% CI) | > 70% | 12.8 (4.31; 27.4) | 13.2 (4.4; 28.1) | ||
| Seroprotection (titre ≥ 40) % (95% CI) | > 60%# | 19.4 (8.2; 36.0) | 29.3 (16.1; 45.5) | ||
n = number of participants
EMA: European Medicines Authority
GMT: Geometric mean titer
GMTR: Geometric mean titer ratio (post-vaccination titer/pre-vaccination titer)
*Seroconversion: subjects with pre-vaccination titers < 8 and post-vaccination titres > 32 or significant increase in titres defined as pre-vaccination titre < 8 with at least a 4-fold increase in post-vaccination titers
# Modified EMA criteria for adults aged over 60 years of age