Purified Rabies Vaccine for Human Use (Chick-embryo Cell)

Novartis

Status and phase: Completed; Phase 3

Conditions: Rabies Post-exposure Prophylaxis

Treatments: Biological: rabies vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00345319

M49P7

Details and patient eligibility

About

Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis regimen to healthy children and adults aged 10-60 years.

Enrollment: 630 patients

Sex: All

Ages: 10 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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630 participants in 2 patient groups

Group 1

Active Comparator group

Treatment:

Biological: rabies vaccine

Group 2

Active Comparator group

Treatment:

Biological: rabies vaccine