Table 2.
Characteristics of Phase II/III randomized control trials included in Lu et al. [39].
| FUTURE I [104] | FUTURE II [46] | PATRICIA [105] | Muñoz [35] |
Koutsky and Mao 106, 107 |
Harper [27] | Villa [30] | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vaccine | Gardasil® | Gardasil® | Cervarix® | Gardasil® | Cervarix® | Cervarix® | Gardasil® | |||||||
| Phase | III | III | III | III | III | III | II | |||||||
| Funding source | Merk | Merk | GlaxoSmithKline | Merk | Merk | GlaxoSmithKline | Merk | |||||||
| No. study sites | 62 | 90 | 135 | 38 | 16 | 32 | 5 | |||||||
| Countries included | 16 | 13 | 14 | 7 | 1 | 3 | 5 | |||||||
| Control | 225 µg Aluminium hydroxyphosphate sulfate | 225 µg Aluminium hydroxyphosphate sulfate | Hepatitis A vaccine | Placebo | Placebo | Placebo | Placebo | |||||||
| Age | 16 – 24 | 15 – 26 | 15 – 25 | 24 – 45 | 16 – 25 | 15 – 25 | 16 – 23 | |||||||
| Case (2673) |
Control (2672) |
Case (6019) |
Control (6031) |
Case (9319) |
Control (9325) |
Case (1908) |
Control (1902) |
Case (1194) |
Control (1198) |
Case (531) |
Control (538) |
Case (272) |
Control (274) |
|
| Injection-related SAE | 1 | 0 | 3 | 2 | 11 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Risk ratio | 3.0 (0.12,73.58) | 1.50 (0.25,8.99) | 1.83 (0.68,4.96) | Not estimable | Not estimable | Not estimable | Not estimable | |||||||
| SAE | 48 | 45 | 45 | 54 | 701 | 699 | 3 | 7 | 4 | 3 | 22 | 19 | 2 | 2 |
| Risk ratio | 1.07 (0.71,1.60) | 0.83 (0.56,1.24) | 1.17 (0.64,2.14) | 0.43 (0.11,1.65) | 1.34 (0.30,5.96) | 1.17 (0.64,2.14) | 1.01 (0.91,1.09) | |||||||