Purified Rabies Vaccine for Human Use (Chick-embryo Cell)
Phase 3
Completed
- Conditions
- Rabies Post-exposure Prophylaxis
- Registration Number
- NCT00345319
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis regimen to healthy children and adults aged 10-60 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 630
Inclusion Criteria
- male and female healthy subjects aged 10-60 years old
Exclusion Criteria
- history of rabies immunization
- previous exposure to a suspect rabid animal within the last 12 months
- any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days
- treatment with corticosteroids, immunosuppressive or anti-malaria drugs during the two month period before enrollment
- known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
- known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method serum bactericidal activity measured at day 14 and day 45 after first vaccination dose
- Secondary Outcome Measures
Name Time Method solicited local and systemic reactions within 6 days following vaccination and adverse events thought the study
Trial Locations
- Locations (1)
Danyang CDC
🇨🇳Danyang, Jiangsu, China
Danyang CDC🇨🇳Danyang, Jiangsu, China