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

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ClinicalTrials.gov Identifier: NCT00345319
Recruitment Status : Completed
First Posted : June 28, 2006
Last Update Posted : December 14, 2011
Sponsor:
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

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00345319


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

Responsible Party: Novartis Vaccines
ClinicalTrials.gov 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 ):
rabies
vaccine
post-exposure prophylaxis

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs