Rabies Post-exposure Prophylaxis
Conditions
Keywords
rabies, vaccine, post-exposure prophylaxis
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.
Interventions
BIOLOGICALrabies vaccine
Administration of PCECV according to ESSEN regimen
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum bactericidal activity | measured at day 14 and day 45 after first vaccination dose |
Secondary
| Measure | Time frame |
|---|---|
| solicited local and systemic reactions | within 6 days following vaccination and adverse events thought the study |
Countries
China
Outcome results
None listed