Table 1.
Baseline characteristics of 83* children and young adults who were randomized to receive either HD TIV or SD TIV.
| Leukemia | Solid Tumor | HIV | ||||
|---|---|---|---|---|---|---|
| Characteristics | HD (N=13) | SD (N=13) | HD (N=8) | SD (N=9) | HD (N=20) | SD (N=20) |
| Age in years, mean (Std) | 10.8 (5.7) | 11.8 (5.1) | 12.4 (4.2) | 11.7 (4.5) | 16.7 (5.6) | 19.9 (1.8) |
| Male gender, n (%) | 9 (69) | 8 (62) | 4 (50) | 5 (56) | 13 (65) | 16 (80) |
| Race, n (%) | ||||||
| White | 12 (92) | 7 (54) | 4 (50) | 4 (44) | 2 (10) | 0 (0) |
| Black | 1 (8) | 5 (38) | 4 (50) | 4 (44) | 18 (90) | 20 (100) |
| Other | 0 (0) | 1 (8) | 0 (0) | 1 (11) | 0 (0) | 0 (0) |
| Subjects with undetectable HIV viral load, n (%) | NA | NA | NA | NA | 15 (75) | 19 (95) |
| Subjects with HIV on antiretroviral therapy, n (%) | NA | NA | NA | NA | 17 (85) | 18 (90) |
| Received influenza vaccine the prior season, n (%) | 9 (75) | 7 (70) | 2 (40) | 4 (80) | 18 (100) | 17 (100) |
| Dexamethasone received | ||||||
| Prior to first dose, n (%) | 8 (100) | 8 (89) | 4 (100) | 4 (100) | NA | NA |
| Prior to second dose, n (%) | 5 (63) | 7 (78) | 2 (50) | 2 (50) | NA | NA |
| White blood cell counts * 103/mm3, median (range) | 2.5 (1.6–13.9) | 3.7 (2–5.4) | 4.4 (2.5–20.3) | 6.2 (1.3–17.5) | 5.25 (3.3–8.6) | 4.65 (3.2–14.5) |
| Absolute lymphocyte cell counts/mm3, median (range) | 518.5 (70–2363) | 725 (190–1665) | 924 (270–5590) | 1027 (78–5250) | 2128 (1755–4731) | 1610 (1120–2296) |
| Immunoglobulin levels in mg/dl, median (range) | ||||||
| IgG | 445 (153–858) | 589 (267–1094) | 744.5 (156–1115) | 948 (317–1202) | 1362.5 (899–2304) | 1246 (1041–2499) |
| IgG1 | 329 (100–502) | 376 (184–712) | 507.5 (107–752) | 641 (261–856) | 949 (623–1870) | 898.5 (651–1890) |
| IgG2 | 95 (23–306) | 118 (68–341) | 153.5 (30–363) | 160 (34–323) | 262 (104–485) | 261.5 (101–500) |
| IgM | 11 (3–70) | 17 (5–152) | 38 (5–101) | 63 (24–134) | 103.5 (41–419) | 75 (41–240) |
| IgA | 29 (9–143) | 49 (17–311) | 92 (15–320) | 120 (17–210) | 187.5 (66–419) | 190.5(93–591) |
*
Two patients (one with leukemia and one with HIV) were lost to follow up before randomization.
HIV, human immunodeficiency virus; HD, high dose; SD, standard dose; TIV, trivalent inactivated influenza vaccine; Ig, immunoglobulin; NA, non-applicable; Std, standard deviation