Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)

A Phase III, Single Center, Randomized, Open-label Study, Comparing PCECV Administered in the Abbreviated Zagreb Regimen (2-1-1) to the Conventional Essen Regimen (1-1-1-1-1) in Healthy Volunteers in China

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

Inclusion Criteria:

• Male and female subjects 18-50 years of age who:
• are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
• volunteer for the simulated post-exposure vaccination courses and blood draws;
• have given a written informed consent; informed consent must be obtained for all the subjects before enrolment in the study;
• are available for all the visits scheduled in the study.

Exclusion Criteria:

• Subjects with the below criteria were excluded:
• pregnancy or unwillingness to practice acceptable contraception during participation in the study;
• a history of rabies immunization;
• a significant acute or chronic infectious disease that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment;
• fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrolment;
• treatment with corticosteroids, immunosuppressive or antimalaria drugs during the two month period before enrolment;
• administration of any vaccine within the past 14 days before enrolment;
• known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
• history of allergy to egg protein;
• known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component;
• treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months;
• mental condition rendering the subject unable to understand the nature, scope and consequences of the study;
• participation in any other investigational trial within the past 3 months before enrolment;
• planned surgery during the study period;
• intention to leave the area of the study site before the end of study period;
• any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.