Status:
COMPLETED
Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)
Lead Sponsor:
Novartis Vaccines
Conditions:
Rabies
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief 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 schedul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
825 Patients enrolled
Trial Details
Trial ID
NCT00825305
Start Date
November 1 2008
End Date
January 1 2009
Last Update
December 13 2011
Active Locations (1)
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1
Jizhou, Hebei, China, 053200