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OpenTrials
Completed

NCT Number: NCT00345319

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

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

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Key information

Conditions

Rabies Post-exposure Prophylaxis Infections Mononegavirales Infections RNA Virus Infections Rabies Rhabdoviridae Infections Virus Diseases

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Danyang CDC

Danyang, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rabies vaccine

Biological

Administration of PCECV according to ESSEN regimen

Primary outcomes

  1. serum bactericidal activity

    Time frame: measured at day 14 and day 45 after first vaccination dose

Secondary outcomes

  1. solicited local and systemic reactions

    Time frame: within 6 days following vaccination and adverse events thought the study

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jun 28, 2006
Registry last updated
Dec 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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