Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)
Condition: Rabies
MeSH terms: Rabies
Intervention: Abbreviated Zagreb 2-1-1 schedule; Standard Essen 1-1-1-1-1 schedule
Intervention description: Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase.; Subjects received the standard Essen regimen.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 825.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine; prevention; rabies; Rabies disease

Summary:

      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
    

Eligibility criteria:

        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.