Immunogenicity and Safety of Verorab™ in Indian Population | NCT00260351

Studies
Immunogenicity and Safety of Verorab™ in Indian Population

NCT00260351

Sponsor

Sanofi Pasteur, a Sanofi Company

Status

Completed

Last Update Posted

Jan 14, 2014Estimated

Enrollment

405Actual

Phase

Phase 4

Conditions

Rabies

Interventions

Purified Verocell Rabies Vaccine
Purified Verocell Rabies Vaccine
Purified Verocell Rabies Vaccine

Countries

India

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

Jan 2014

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

Dec 2004

Primary Completion Date

Aug 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Nov 29, 2005

First Submission Date that Met QC Criteria

Nov 29, 2005

First Posted Date

Dec 1, 2005Estimated

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

Jan 10, 2014

Last Update Posted Date

Jan 14, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To demonstrate that rabies vaccine administered according to the Thai Red Cross, (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects with a WHO category III rabies exposure,or,
To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen (2-1-1) is not inferior to Rabies vaccine administered according to the ESSEN IM regimen in terms of GMTs at D28, in subjects with a WHO category III rabies exposure.

Secondary objectives:

To describe the immunogenicity profile of each regimen
To assess the safety of the vaccine in each group.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

405Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	Participants on Thai Red Cross, TRC-ID regimen	Biological: Purified Verocell Rabies Vaccine
Group 2	Experimental	Participants on Zagreb-IM regimen	Biological: Purified Verocell Rabies Vaccine
Group 3	Experimental	Participants on Essen-IM regimen.	Biological: Purified Verocell Rabies Vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Purified Verocell Rabies Vaccine	Biological	0.1 mL, ID (TRC regimen)	Group 1

Measure	Description	Time Frame
Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine		6 months post-vaccination

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject with WHO category III rabies exposure
Subject aged at least 2 years old (day of second birthday)

Exclusion Criteria:

Subject unable to comply with the follow-up schedule of the protocol
Delayed post-exposure treatment (>72 hours between incident and treatment
Subject bitten by an observable animal at the inclusion visit
Subject with immune-compromised or underlying diseases which may lead to inferior immune response
Subject with known pregnancy at the time of inclusion
Subject enrolled or scheduled to be enrolled in another clinical study.
Subject with acute febrile illness/ axillary temperature > 37.5 degree celsius
Subject in whom blood sampling will be difficult.
Subject receiving chloroquine or other anti-malarial treatment
Subject receiving immunosuppressive therapy, other immune-modifying drug or cytotoxic drugs
Subject with known chronic illnesses (ie. heart, lung, kidney, liver) including immunosuppressive diseases (cancer, HIV, etc.)
Previous rabies immunization
Subject having received any vaccine within the previous 30 days, except tetanus toxoid and tetanus immunoglobulin
Subject with clinical signs of rabies
Subject with known allergy to vaccine components (e.g. neomycin)
Subject who received blood and/or plasma transfusion within the past 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Hyderabad			India

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