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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00345319
First received: June 27, 2006
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Rabies Post-exposure Prophylaxis
 Biological: rabies vaccine
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Rabies
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • serum bactericidal activity [ Time Frame: measured at day 14 and day 45 after first vaccination dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • solicited local and systemic reactions [ Time Frame: within 6 days following vaccination and adverse events thought the study ] [ Designated as safety issue: Yes ]

Enrollment: 630
Study Start Date: March 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1 Biological: rabies vaccine
Administration of PCECV according to ESSEN regimen
Active Comparator: Group 2 Biological: rabies vaccine
Administration of PCECV according to ESSEN regimen

  Eligibility

Ages Eligible for Study:   10 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345319

Locations
China, Jiangsu
Danyang CDC
Danyang, Jiangsu, China
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines - Information Services Novartis Vaccines & Diagnostics
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00345319     History of Changes
Other Study ID Numbers: M49P7
Study First Received: June 27, 2006
Last Updated: December 12, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
rabies
vaccine
post-exposure prophylaxis

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013