NCT00345319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
Last Updated

December 14, 2011

Status Verified

December 1, 2011

Enrollment Period

2 months

First QC Date

June 27, 2006

Last Update Submit

December 12, 2011

Conditions

Rabies Post-exposure Prophylaxis

Keywords

rabiesvaccinepost-exposure prophylaxis

Outcome Measures

Primary Outcomes (1)

  • serum bactericidal activity

    measured at day 14 and day 45 after first vaccination dose

Secondary Outcomes (1)

  • solicited local and systemic reactions

    within 6 days following vaccination and adverse events thought the study

Study Arms (2)

Group 1

ACTIVE COMPARATOR
Biological: rabies vaccine

Group 2

ACTIVE COMPARATOR
Biological: rabies vaccine

Interventions

rabies vaccineBIOLOGICAL

Administration of PCECV according to ESSEN regimen

Group 1Group 2

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • male and female healthy subjects aged 10-60 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danyang CDC

Danyang, Jiangsu, China

Location

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

Rhabdoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Novartis Vaccines - Information Services

    Novartis Vaccines & Diagnostics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 28, 2006

Study Start

March 1, 2006

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

December 14, 2011

Record last verified: 2011-12

Locations

CN(1)