Table 3.
SCR |
SPR |
|||||
---|---|---|---|---|---|---|
Group | Studies (n) | Rate (95% CI) | Studies (n) | Rate (95% CI) | CHMP | CBER |
3.75 µg | ||||||
No adjuvant | 225,35 | 0.13(−0.03,0.29) | 225,35 | 0.13(−0.13,0.29) | NO | NO |
MF59 | 230,37 | 0.59(0.50,0.68) | 230,37 | 0.53(0.49,0.56) | SCR | SCR |
AS03 | 135 | 0.72(0.65,0.79) | 135 | 0.65(0.58,0.73) | SCR/SPR | SCR/SPR |
Alum | 125 | 0.08(0.00,0.15) | 125 | 0.16(0.06,0.26) | NO | NO |
7.5 µg | ||||||
No adjuvant | 425,29,34,35 | 0.33(0.13,0.53) | 425,29,34,35 | 0.42(0.20,0.64) | SCR | SCR |
MF59 | 530–33,37 | 0.64(0.50,0.78) | 530–33,37 | 0.62(0.56,0.68) | SCR/SPR | SCR/SPR |
AS03 | 135 | 0.88(0.83.0.94) | 135 | 0.79(0.73,0.86) | SCR/SPR | SCR/SPR |
Alum | 125 | 0.12(0.04,0.20) | 125 | 0.19(0.09,0.29) | NO | NO |
15 µg | ||||||
No adjuvant | 125 | 0.21(0.11,0.32) | 125 | 0.29(0.17,0.40) | NO | NO |
MF59 | 132 | 0.70(0.60,0.81) | 132 | 0.65(0.54,0.76) | SCR/SPR | SCR/SPR |
Alum | 125 | 0.13(0.04,0.32) | 125 | 0.15(0.06,0.25) | NO | NO |
Abbreviations: Alum, aluminum; SCR, seroconversion rate; SPR, seroprotection rate; CI, confidence interval; CHMP, European Committee for Medicinal Products for Human Use; CBER, Center for Biologics Evaluation and Research.