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

Rabies Post-exposure Prophylaxis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345319
• Other study ID #: M49P7
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2006
• Last updated: December 12, 2011
• Start date: March 2006
• Est. completion date: May 2006

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rabies
• Rabies Post-exposure Prophylaxis

Intervention

Biological:
• rabies vaccine
Administration of PCECV according to ESSEN regimen

Locations

Country	Name	City	State
China	Danyang CDC	Danyang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum bactericidal activity		measured at day 14 and day 45 after first vaccination dose	No
Secondary	solicited local and systemic reactions		within 6 days following vaccination and adverse events thought the study	Yes