Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00948272

Purpose

The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.

Primary Objective:

To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series.

Secondary Objectives:

To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects.
To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.

Condition	Intervention	Phase
Rabies	Biological: Purified Vero Rabies Vaccine - Serum Free Biological: Purified inactivated rabies vaccine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults

Resource links provided by NLM:

MedlinePlus related topics: Rabies

Drug Information available for: Rabies Vaccine Rabies Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine. [ Time Frame: 42 days post-primary series vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To provide information concerning the safety after Purified Vero Rabies Vaccine. [ Time Frame: 0 to 7 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment:	384
Study Start Date:	July 2009
Study Completion Date:	August 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VRVg Group	Biological: Purified Vero Rabies Vaccine - Serum Free 0.5 mL, Intramuscular Other Name: VRVg
Active Comparator: Verorab Group	Biological: Purified inactivated rabies vaccine 0.5 mL, Intramuscular Other Name: Verorab

Detailed Description:

All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria :

Aged 18 to 60 years on the day of inclusion
Provision of a signed Informed Consent Form
Able to attend all scheduled visits and comply with all trial procedures
For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination)
Entitlement to national social security

Exclusion Criteria :

For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
Breast-feeding woman
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
Planned receipt of any vaccine in the 4 weeks following any trial vaccination
Known human immunodeficiency virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity
Previous vaccination against rabies with any vaccine (in pre- or post-exposure regimen)
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
Subject at high risk for rabies exposure during the trial period
Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
Study site employee who is involved in the protocol and may have direct access to trial related data.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948272

Locations

France

Gières, France, 38610

Montpellier Cedex 5, France, 34094

Pierre Bénite, France, 69130

Poitiers, France, 86000

Rennes, France, 35000

Rueil Malmaison, France, 92502

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00948272 History of Changes
Other Study ID Numbers:	VRV01, UTN: U1111-1111-4382
Study First Received:	July 28, 2009
Last Updated:	October 5, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

Rabies
Rabies virus
Purified Vero Rabies Vaccine
Serum Free

Additional relevant MeSH terms:

Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 09, 2012