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

NCT ID: NCT00345319

Last Updated: 2011-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-05-31

Brief Summary

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

Detailed Description

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Conditions

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Rabies Post-exposure Prophylaxis

Keywords

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rabies vaccine post-exposure prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

Group Type ACTIVE_COMPARATOR

rabies vaccine

Intervention Type BIOLOGICAL

Administration of PCECV according to ESSEN regimen

Group 2

Group Type ACTIVE_COMPARATOR

rabies vaccine

Intervention Type BIOLOGICAL

Administration of PCECV according to ESSEN regimen

Interventions

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rabies vaccine

Administration of PCECV according to ESSEN regimen

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines - Information Services

Role: STUDY_CHAIR

Novartis Vaccines & Diagnostics

Locations

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Danyang CDC

Danyang, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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M49P7

Identifier Type: -

Identifier Source: org_study_id