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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014