Table 4.
Number (percentage and 95% confidence interval) of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (per-protocol set)*
| Cohort 1 (9–17 years) | Cohort 2 (3–8 years) | Cohort 3 (1–<3 years) | Cohort 4 (6–11 months) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 3.75 μg +halfMF59 (n = 72 ) | 7.5 μg +fullMF59 (n = 71 ) | 3.75 μg+halfMF59 (n = 58 ) | 7.5 μg +fullMF59 (n = 60 ) | 15 μg +noMF59 (n = 31 ) | 3.75 μg +halfMF59 (n = 51 ) | 7.5 μg +fullMF59 (n = 53 ) | 15 μg +noMF59 (n = 25 ) | 3.75 μg +halfMF59 (n = 58 ) | 7.5 μg +fullMF59 (n = 54 ) | |
| Day 22 | 56 (78)† (66–87) | 63 (89)† (79–95) | 46 (79)† (67–89) | 50 (83)† (71–92) | 20 (65)† (45–81) | 37 (73)† (58–84) | 41 (77)† (64–88) | 8 (32) (15–54) | 33 (57)† (43–70) | 40 (74)† (60–85) |
| Day 43 | 71 (99)† (93–100) | 71 (100)† (95–100) | 58 (100)† (94–100) | 60 (100)† (94–100) | 30 (97)† (83–100) | 50 (98)† (90–100) | 53 (100)† (93–100) | 21 (84)† (64–95) | 57 (98)† (91–100) | 54 (100)† (93–100) |
| Pre-booster | n = 21 | n = 22 | n = 24 | n = 31 | n = 11 | n = 36 | n = 41 | n = 19 | n = 52 | n = 46 |
| Day 366 (from day 1) | 18 (86) (64–97) | 21 (95) (77–100) | 24 (100) (86–100) | 31 (100) (89–100) | 10 (91) (59–100) | 33 (92) (78–98) | 37 (90) (77–97) | 9 (47) (24–71) | 43 (83) (70–92) | 42 (91) (79–98) |
| Post-booster | n = 19 | n = 20 | n = 20 | n = 29 | n = 10 | n = 32 | n = 38 | n = 17 | n = 47 | n = 40 |
| Day 387 (from day 1) | 19 (100) (82–100) | 20 (100) (83–100) | 20 (100) (83–100) | 29 (100) (88–100) | 10 (100) (69–100) | 32 (100) (89–100) | 38 (100) (91–100) | 17 (100) (80–100) | 46 (98) (89–100) | 40 (100) (91–100) |
| Day 387 (from day 366) | 17 (89)† (67–99) | 16 (80)† (56–94) | 19 (95)† (75–100) | 29 (100)† (88–100) | 10 (100)† (69–100) | 30 (94)† (79–99) | 36 (95)† (82–99) | 17 (100)† (80–100) | 40 (85)† (72–94) | 36 (90)† (76–97) |
*Data presented for days 1–366 are derived from a re-analysis of the original dataset following protocol violation regarding the administration of the booster. This violation required the retrospective removal of the non-compliant site data from the original data set. Data presented for the booster correspond to the original dataset as the non-compliant site did not contribute post-booster data. †Percentage of subjects achieving seroconversion or significant increase in hemagglutination inhibition is ≥40 %.