This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in China
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
825
Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase.
Subjects received the standard Essen regimen.
Unnamed facility
Jizhou, Hebei, China
Rabies Virus Neutralizing Antibody Concentrations on Day 14.
Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.
Time frame: 14 days
Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination
Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.
Time frame: 7 days after each vaccination
Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.
Rabies virus neutralizing antibody concentrations the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.
Time frame: 7 days and 42 days
Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.
Percentages of participants with seroconversion (defined as rabies virus neutralizing antibody concentrations equal and above 0.5 IU/ml) on days 7, 14 and 42.
Time frame: 7 days, 14 days and 42 days
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