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

Novartis

Status and phase

Completed

Phase 3

Conditions

Rabies

Treatments

Biological: Standard Essen 1-1-1-1-1 schedule

Biological: Abbreviated Zagreb 2-1-1 schedule

Study type

Interventional

Funder types

Industry

Identifiers

NCT00825305

M49P8

Details and patient eligibility

About

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

Enrollment

825 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.