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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Rabies

Treatments

Biological: Purified Vero Rabies Vaccine - Serum Free

Biological: Purified inactivated rabies vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00948272

UTN: U1111-1111-4382

VRV01

Details and patient eligibility

About

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.

Full description

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

Enrollment

384 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.