TABLE 1

Study Groups, Baseline Characteristics, and Disposition of Study Participants

ToddlersChildrenAdolescents
H5N1 VaccineSeasonal VaccineH5N1 VaccineSeasonal VaccineH5N1 VaccineSeasonal Vaccine
No. assigned randomly1455696409441
Age ± SD19.1 ± 8.7 mo18.7 ± 9.1 mo5.5 ± 1.7 y5.5 ± 1.6 y13.0 ± 2.7 y13.0 ± 2.7 y
Male, %464854683951
Previous influenza vaccination, %a2261332
Voluntary withdrawal, n (%)8 (6)0 (0)3 (3)2 (5)4 (4)1 (2)
Safety population, n (%)b145 (100)56 (100)96 (100)40 (100)93 (99)41 (100)
Full analysis set for HI, n (%)134 (92)55 (98)91 (95)40 (100)89 (95)40 (98)
Per-protocol analysis set for HI, n (%)93 (64)37 (66)77 (80)34 (85)78 (83)35 (85)
Full analysis set for SRH and microneutralization, n (%)137 (94)55 (98)91 (95)40 (100)90 (96)40 (98)
Per-protocol analysis set for SRH and microneutralization, n (%)95 (66)37 (66)77 (80)34 (85)79 (84)35 (85)
  • a Influenza vaccination was in a previous season, and therefore inclusion criteria were met.

  • b Participants who received ≥1 dose of vaccine.