Back to resultsPurified Rabies Vaccine for Human Use (Chick-embryo Cell)
Primary Purpose
Rabies Post-exposure Prophylaxis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
rabies vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Rabies Post-exposure Prophylaxis focused on measuring rabies, vaccine, post-exposure prophylaxis
Eligibility Criteria
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
Sites / Locations
- Danyang CDC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Outcomes
Primary Outcome Measures
serum bactericidal activity
Secondary Outcome Measures
solicited local and systemic reactions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00345319
Brief Title
Purified Rabies Vaccine for Human Use (Chick-embryo Cell)
Official Title
Evaluate the Immunogenicity and Safety of Rabies Vaccine Given in a Post-exposure Prophylaxis Regimen to Healthy Children and Adults Aged 10-60 Years.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies Post-exposure Prophylaxis
Keywords
rabies, vaccine, post-exposure prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
630 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Title
Group 2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
rabies vaccine
Intervention Description
Administration of PCECV according to ESSEN regimen
Primary Outcome Measure Information:
Title
serum bactericidal activity
Time Frame
measured at day 14 and day 45 after first vaccination dose
Secondary Outcome Measure Information:
Title
solicited local and systemic reactions
Time Frame
within 6 days following vaccination and adverse events thought the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines - Information Services
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Study Chair
Facility Information:
Facility Name
Danyang CDC
City
Danyang
State/Province
Jiangsu
Country
China
12. IPD Sharing Statement
Learn more about this trial
Purified Rabies Vaccine for Human Use (Chick-embryo Cell)
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