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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00345319
Recruitment Status : Completed
First Posted : June 28, 2006
Last Update Posted : December 14, 2011
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

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.

Condition or disease Intervention/treatment Phase
Rabies Post-exposure Prophylaxis Biological: rabies vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : March 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. serum bactericidal activity [ Time Frame: measured at day 14 and day 45 after first vaccination dose ]

Secondary Outcome Measures :
  1. solicited local and systemic reactions [ Time Frame: within 6 days following vaccination and adverse events thought the study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00345319

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

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Responsible Party: Novartis Vaccines Identifier: NCT00345319     History of Changes
Other Study ID Numbers: M49P7
First Posted: June 28, 2006    Key Record Dates
Last Update Posted: December 14, 2011
Last Verified: December 2011
Keywords provided by Novartis ( Novartis Vaccines ):
post-exposure prophylaxis
Additional relevant MeSH terms:
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Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs