Rabies Clinical Trial
Official title:
A Phase IIIb, Randomized, Open-label Study Comparing Two Different Rabies Vaccine Post-exposure Schedules (Zagreb 2-1-1 and Rabipur® Essen 1-1-1-1-1) in Chinese Children and Older Adults
This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.
This study was designed to evaluate the safety and immunogenicity of Rabipur Zagreb (2-1-1)
and Rabipur Essen (1-1-1-1-1) simulated post exposure vaccination schedules in Chinese
children and older adults. Subjects randomized to Group 1 (Zagreb) will receive 4 doses of
rabies vaccine Day 1 (2 doses), and on Day 8 and Day 22. Subjects randomized to Group 2
(Essen) will receive 5 doses of rabies vaccine on Days 1, 4, 8, 15, and 29. First vaccine
will be administered on study Day 1.
240 children and 400 older adults, a total of 640, is planned to be enrolled into the study.
Subjects will be divided further into age subsets of equal numbers within each age cohort
(children: 6 to 11 years of age and 12 to 17 years of age; older adults: 51 to 60 years of
age and 61 years of age and older. Within each age subset, subjects will be assigned
randomly in a 1:1 ratio.
The primary objective is to establish the non-inferiority of the Rabipur Zagreb (2-1-1)
schedule relative to the conventional Rabipur Essen (1-1-1-1-1) schedule based on geometric
mean titers (GMC), and the secondary objective is to assess the percent of subjects with
rabies virus neutralizing titer ≥ 0.5 IU/mL 14 days after the first vaccinations (study Day
15) for each schedule and age cohort
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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