Purified Rabies Vaccine for Human Use (Chick-embryo Cell) | NCT00345319

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

NCT00345319

Sponsor

Novartis Vaccines

Status

Completed

Last Update Posted

Dec 14, 2011Estimated

Enrollment

630Actual

Phase

Phase 3

Conditions

Rabies Post-exposure Prophylaxis

Interventions

rabies vaccine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Jun 27, 2006

First Submission Date that Met QC Criteria

Jun 27, 2006

First Posted Date

Jun 28, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2011

Last Update Posted Date

Dec 14, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

630Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator		Biological: rabies vaccine
Group 2	Active Comparator		Biological: rabies vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rabies vaccine	Biological	Administration of PCECV according to ESSEN regimen	Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum bactericidal activity		measured at day 14 and day 45 after first vaccination dose

Secondary Outcomes

Measure	Description	Time Frame
solicited local and systemic reactions		within 6 days following vaccination and adverse events thought the study

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Vaccines - Information Services	Novartis Vaccines & Diagnostics	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danyang CDC		Danyang	Jiangsu		China

Condition Browse Module

MeSH Terms

ID	Term
D011818	Rabies

Ancestor Terms

ID	Term
D018353	Rhabdoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011819	Rabies Vaccines

Ancestor Terms

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided