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

This is an interventional prevention trial for Rabies focused on measuring Rabies, Rabies virus, Purified Vero Rabies Vaccine, Serum Free Read More

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.