Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults

May 27, 2014 updated by: Sanofi Pasteur, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Gières, France, 38610
      • Montpellier Cedex 5, France, 34094
      • Pierre Bénite, France, 69130
      • Poitiers, France, 86000
      • Rennes, France, 35000
      • Rueil Malmaison, France, 92502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VRVg Group
Biological: Purified Vero Rabies Vaccine - Serum Free
0.5 mL, Intramuscular
Other Names:
  • VRVg
Active Comparator: Verorab Group
Biological: Purified inactivated rabies vaccine
0.5 mL, Intramuscular
Other Names:
  • Verorab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine.
Time Frame: 42 days post-primary series vaccination
42 days post-primary series vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the safety after Purified Vero Rabies Vaccine.
Time Frame: 0 to 7 days post-vaccination and entire study duration
0 to 7 days post-vaccination and entire study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 28, 2009

First Submitted That Met QC Criteria

July 28, 2009

First Posted (Estimate)

July 29, 2009

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRV01
  • UTN: U1111-1111-4382

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rabies

Clinical Trials on Purified Vero Rabies Vaccine - Serum Free

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe